Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2026-01-05 @ 7:53 AM
Study NCT ID:
NCT02539368
Status:
COMPLETED
Last Update Posted:
2020-02-13
First Post:
2015-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000591237', 'term': 'CT-P13'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Same event may appear as both an adverse event (AE) and serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Safety population was evaluated.', 'eventGroups': [{'id': 'EG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months.", 'otherNumAtRisk': 1522, 'deathsNumAtRisk': 1522, 'otherNumAffected': 442, 'seriousNumAtRisk': 1522, 'deathsNumAffected': 4, 'seriousNumAffected': 256}, {'id': 'EG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.', 'otherNumAtRisk': 494, 'deathsNumAtRisk': 494, 'otherNumAffected': 100, 'seriousNumAtRisk': 494, 'deathsNumAffected': 2, 'seriousNumAffected': 43}, {'id': 'EG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.', 'otherNumAtRisk': 358, 'deathsNumAtRisk': 358, 'otherNumAffected': 90, 'seriousNumAtRisk': 358, 'deathsNumAffected': 1, 'seriousNumAffected': 57}, {'id': 'EG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 7, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 10}, {'id': 'EG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.', 'otherNumAtRisk': 102, 'deathsNumAtRisk': 102, 'otherNumAffected': 21, 'seriousNumAtRisk': 102, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Iron deficiency anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Lymphadenopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Acute coronary syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cardiovascular insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Neurosensory hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Thyroiditis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Scleritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vision blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Abdominal tenderness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Anal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastrointestinal anastomotic stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastrointestinal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Ileal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hiatus hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Large intestinal stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Obstruction gastric', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Oesophagitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancreatic failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pouchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 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'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Gastrointestinal stromal tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Intraductal proliferative breast lesion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 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'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Seminoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 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'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Cutaneous vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Dermatitis psoriasiform', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Hidradenitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Palmoplantar pustulosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pustular psoriasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Skin reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Caesarean section', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Colectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Ventriculo-peritoneal shunt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Aortic aneurysm rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': "Behcet's syndrome", 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Circulatory collapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Femoral artery embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Poor venous access', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 1522, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 494, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 358, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 67, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 102, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v21.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Disease Characteristics of Participants: Disease Duration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1519', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '579'}, {'value': '112.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '632'}, {'value': '120.0', 'groupId': 'OG002', 'lowerLimit': '2', 'upperLimit': '593'}, {'value': '86.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '519'}, {'value': '101.0', 'groupId': 'OG004', 'lowerLimit': '9', 'upperLimit': '457'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline (Day 1)', 'description': 'Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).', 'unitOfMeasure': 'months', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Switched Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '358', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '102', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG001', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'title': "Crohn's Disease", 'measurements': [{'value': '237', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}]}, {'title': 'Ulcerative Colitis', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.'}, {'type': 'PRIMARY', 'title': 'Reasons for Switching Treatment by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'reportingStatus': 'POSTED', 'populationDescription': 'Reasons for switch were not captured in electronic data capture. Hence, due to change in planned analysis, data was not collected and analyzed.'}, {'type': 'PRIMARY', 'title': 'Total Dose of Infusion Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1520', 'groupId': 'OG000'}, {'value': '493', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Due to inconsistency in reporting of total daily dose, the median total dose and full range could not be estimated.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to inconsistency in reporting of total daily dose, the median total dose and full range could not be estimated.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to inconsistency in reporting of total daily dose, the median total dose and full range could not be estimated.', 'groupId': 'OG002', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to inconsistency in reporting of total daily dose, the median total dose and full range could not be estimated.', 'groupId': 'OG003', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Due to inconsistency in reporting of total daily dose, the median total dose and full range could not be estimated.', 'groupId': 'OG004', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Total dose of infusion received by the participants was calculated.', 'unitOfMeasure': 'milligram', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants by Frequency of Infusion Received', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1283', 'groupId': 'OG000'}, {'value': '433', 'groupId': 'OG001'}, {'value': '317', 'groupId': 'OG002'}, {'value': '60', 'groupId': 'OG003'}, {'value': '85', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'title': 'Once a week', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Once every 2 weeks', 'measurements': [{'value': '140', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Once every 3 weeks', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Once every 4 weeks', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'Once every 5 weeks', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Once every 6 weeks', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}, {'title': 'Once every 7 weeks', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Once every 8 weeks', 'measurements': [{'value': '804', 'groupId': 'OG000'}, {'value': '247', 'groupId': 'OG001'}, {'value': '198', 'groupId': 'OG002'}, {'value': '42', 'groupId': 'OG003'}, {'value': '47', 'groupId': 'OG004'}]}, {'title': 'Other', 'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline (Day 1)', 'description': "Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Change in Infusion Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1522', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'measurements': [{'value': '479', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change', 'denoms': [{'units': 'Participants', 'counts': [{'value': '479', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': "Principal Investigator's Decision", 'categories': [{'measurements': [{'value': '213', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}]}, {'title': "Participant's Decision", 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Loss of response', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}]}, {'title': 'Lack of compliance', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Hypersensitivity', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Occurrence of Adverse Event (including AESI/SAE)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Positive for antibodies', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '142', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': "Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest \\[AESI\\]/ serious adverse event \\[SAE\\]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety analysis population included all participants who received at least 1 dose of study drug during the observation period. Here, 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'PRIMARY', 'title': "Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '1522', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'measurements': [{'value': '1025', 'groupId': 'OG000'}, {'value': '262', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}, {'value': '39', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1522', 'groupId': 'OG000'}, {'value': '494', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '621', 'groupId': 'OG000'}, {'value': '133', 'groupId': 'OG001'}, {'value': '130', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '256', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '15', 'groupId': 'OG004'}]}]}, {'title': 'TEAEs of Special Interest', 'categories': [{'measurements': [{'value': '189', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.'}, {'type': 'SECONDARY', 'title': 'Number of Participants Remaining in Clinical Remission or Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1516', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1036', 'groupId': 'OG000'}, {'value': '335', 'groupId': 'OG001'}, {'value': '280', 'groupId': 'OG002'}, {'value': '54', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '870', 'groupId': 'OG000'}, {'value': '312', 'groupId': 'OG001'}, {'value': '261', 'groupId': 'OG002'}, {'value': '51', 'groupId': 'OG003'}, {'value': '70', 'groupId': 'OG004'}]}, {'title': 'Relapse', 'measurements': [{'value': '166', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '914', 'groupId': 'OG000'}, {'value': '306', 'groupId': 'OG001'}, {'value': '240', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '64', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '802', 'groupId': 'OG000'}, {'value': '288', 'groupId': 'OG001'}, {'value': '224', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '58', 'groupId': 'OG004'}]}, {'title': 'Relapse', 'measurements': [{'value': '112', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '703', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}, {'value': '203', 'groupId': 'OG002'}, {'value': '32', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '633', 'groupId': 'OG000'}, {'value': '257', 'groupId': 'OG001'}, {'value': '192', 'groupId': 'OG002'}, {'value': '31', 'groupId': 'OG003'}, {'value': '61', 'groupId': 'OG004'}]}, {'title': 'Relapse', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '424', 'groupId': 'OG000'}, {'value': '191', 'groupId': 'OG001'}, {'value': '157', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '386', 'groupId': 'OG000'}, {'value': '184', 'groupId': 'OG001'}, {'value': '148', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}, {'title': 'Relapse', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Months 6, 12, 18 and 24', 'description': "Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS)=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to assessment of CD or UC).Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '485', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '125', 'groupId': 'OG002'}, {'value': '24', 'groupId': 'OG003'}, {'value': '43', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '429', 'groupId': 'OG000'}, {'value': '182', 'groupId': 'OG001'}, {'value': '109', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '42', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '326', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}, {'value': '96', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '37', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '247', 'groupId': 'OG000'}, {'value': '88', 'groupId': 'OG001'}, {'value': '48', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '194', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '68', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '606', 'groupId': 'OG000'}, {'value': '246', 'groupId': 'OG001'}, {'value': '150', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}, {'value': '49', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '391', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '17', 'groupId': 'OG003'}, {'value': '19', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than \\[\\<\\] 5), mild disease (MD) (score equal to \\[=\\] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than \\[\\>\\] 16).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline: MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}, {'title': 'At Baseline: Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'At Baseline: SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; 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Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '85', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '91', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score \\< 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score \\>16).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '117', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 12-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '88', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 18-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-CR; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '103', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '29', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having \\>=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS \\<2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS \\>6).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline: MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}]}, {'title': 'At Baseline: Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}]}, {'title': 'At Baseline: SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 6-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 6-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 6-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 6-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 6-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 12-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 12-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 12-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 12-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 12-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 12-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 12-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 12-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 12-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 12-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 12-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 12-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 12-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 12-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 12-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 18-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 18-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 18-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 18-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 18-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '68', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 18-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 18-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 18-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 18-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 18-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 18-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 18-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 18-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 18-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 18-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-MD; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '157', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-Mod D; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-CR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-MD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-Mod D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-SD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Baseline-SD; Month 24-Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having \\>=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS \\<2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS \\>6).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis", 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'title': '16 years or younger', 'measurements': [{'value': '61', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': '17-40 years', 'measurements': [{'value': '553', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '115', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}, {'value': '39', 'groupId': 'OG004'}]}, {'title': 'Over 40 years', 'measurements': [{'value': '162', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At Baseline', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified rows for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline: Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'title': 'L1 Terminal ileum', 'measurements': [{'value': '257', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}, {'value': '34', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'L2 Colon', 'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '54', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon', 'measurements': [{'value': '329', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '80', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '28', 'groupId': 'OG004'}]}, {'title': 'L4 Upper GI', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L1 Terminal ileum, L4 Upper GI', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'L2 Colon, L4 Upper GI', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon, L4 Upper GI', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 6: Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'title': 'L1 Terminal ileum', 'measurements': [{'value': '202', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'L2 Colon', 'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon', 'measurements': [{'value': '236', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '65', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}, {'title': 'L4 Upper GI', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L1 Terminal ileum, L4 Upper GI', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L2 Colon, L4 Upper GI', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon, L4 Upper GI', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 12: Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'title': 'L1 Terminal ileum', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'L2 Colon', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon', 'measurements': [{'value': '200', 'groupId': 'OG000'}, {'value': '71', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '21', 'groupId': 'OG004'}]}, {'title': 'L4 Upper GI', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'L1 Terminal ileum, L4 Upper GI', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L2 Colon, L4 Upper GI', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon, L4 Upper GI', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 18: Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'title': 'L1 Terminal ileum', 'measurements': [{'value': '99', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'L2 Colon', 'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon', 'measurements': [{'value': '150', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}, {'title': 'L4 Upper GI', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'L1 Terminal ileum, L4 Upper GI', 'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L2 Colon, L4 Upper GI', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon, L4 Upper GI', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 24: Location', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'title': 'L1 Terminal ileum', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'L2 Colon', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}, {'title': 'L4 Upper GI', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'L1 Terminal ileum, L4 Upper GI', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L2 Colon, L4 Upper GI', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'L3 Ileocolon, L4 Upper GI', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'At Baseline: Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '777', 'groupId': 'OG000'}, {'value': '240', 'groupId': 'OG001'}, {'value': '164', 'groupId': 'OG002'}, {'value': '37', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}], 'categories': [{'title': 'B1 NS, NP', 'measurements': [{'value': '324', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing', 'measurements': [{'value': '165', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating', 'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'p Perianal disease', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B1 NS,NP, p Perianal disease', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, p Perianal disease', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating, p Perianal disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating, p Perianal disease', 'measurements': [{'value': '57', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 6: Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '589', 'groupId': 'OG000'}, {'value': '202', 'groupId': 'OG001'}, {'value': '127', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '44', 'groupId': 'OG004'}]}], 'categories': [{'title': 'B1 NS, NP', 'measurements': [{'value': '242', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}, {'value': '46', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '36', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'p Perianal disease', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B1 NS,NP, p Perianal disease', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, p Perianal disease', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating, p Perianal disease', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating, p Perianal disease', 'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 12: Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'OG000'}, {'value': '160', 'groupId': 'OG001'}, {'value': '104', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}, {'value': '40', 'groupId': 'OG004'}]}], 'categories': [{'title': 'B1 NS, NP', 'measurements': [{'value': '191', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}, {'value': '40', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing', 'measurements': [{'value': '94', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '28', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating', 'measurements': [{'value': '48', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'p Perianal disease', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B1 NS,NP, p Perianal disease', 'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, p Perianal disease', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating, p Perianal disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating, p Perianal disease', 'measurements': [{'value': '33', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 18: Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '330', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}, {'value': '85', 'groupId': 'OG002'}, {'value': '22', 'groupId': 'OG003'}, {'value': '36', 'groupId': 'OG004'}]}], 'categories': [{'title': 'B1 NS, NP', 'measurements': [{'value': '135', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'p Perianal disease', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B1 NS,NP, p Perianal disease', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, p Perianal disease', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating, p Perianal disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating, p Perianal disease', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 24: Behavior', 'denoms': [{'units': 'Participants', 'counts': [{'value': '190', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '18', 'groupId': 'OG003'}, {'value': '27', 'groupId': 'OG004'}]}], 'categories': [{'title': 'B1 NS, NP', 'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing', 'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating', 'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'p Perianal disease', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B1 NS,NP, p Perianal disease', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, p Perianal disease', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B2 Stricturing, B3 Penetrating, p Perianal disease', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'B3 Penetrating, p Perianal disease', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'title': 'E1 Ulcerative proctitis', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'E2 Left-sided UC', 'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '30', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'E3 Extensive UC', 'measurements': [{'value': '188', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'title': 'E1 Ulcerative proctitis', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'E2 Left-sided UC', 'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'E3 Extensive UC', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '13', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'title': 'E1 Ulcerative proctitis', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'E2 Left-sided UC', 'measurements': [{'value': '76', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'E3 Extensive UC', 'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'title': 'E1 Ulcerative proctitis', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'E2 Left-sided UC', 'measurements': [{'value': '55', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}, {'title': 'E3 Extensive UC', 'measurements': [{'value': '96', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'E1 Ulcerative proctitis', 'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'E2 Left-sided UC', 'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'E3 Extensive UC', 'measurements': [{'value': '59', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '547', 'groupId': 'OG000'}, {'value': '144', 'groupId': 'OG001'}, {'value': '121', 'groupId': 'OG002'}, {'value': '20', 'groupId': 'OG003'}, {'value': '30', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '380', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}, {'value': '66', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '22', 'groupId': 'OG004'}]}], 'categories': [{'title': 'S0', 'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '24', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'S1', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'S2', 'measurements': [{'value': '147', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'S3', 'measurements': [{'value': '75', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '302', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '20', 'groupId': 'OG004'}]}], 'categories': [{'title': 'S0', 'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'S1', 'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'S2', 'measurements': [{'value': '74', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '3', 'groupId': 'OG004'}]}, {'title': 'S3', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '38', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '18', 'groupId': 'OG004'}]}], 'categories': [{'title': 'S0', 'measurements': [{'value': '110', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'S1', 'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'S2', 'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'S3', 'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '168', 'groupId': 'OG000'}, {'value': '53', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '17', 'groupId': 'OG004'}]}], 'categories': [{'title': 'S0', 'measurements': [{'value': '81', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'S1', 'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'S2', 'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'S3', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '101', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'S0', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'S1', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'S2', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'S3', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day \\[with or without blood\\], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': "Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index", 'denoms': [{'units': 'Participants', 'counts': [{'value': '969', 'groupId': 'OG000'}, {'value': '348', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '47', 'groupId': 'OG003'}, {'value': '72', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '191', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '12', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}]}, {'title': 'Improvement', 'measurements': [{'value': '90', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Worsened', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Unchanged', 'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Not accessible', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '65', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Improvement', 'measurements': [{'value': '62', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}]}, {'title': 'Worsened', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Unchanged', 'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Not accessible', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}]}, {'title': 'Improvement', 'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Worsened', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Unchanged', 'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Not accessible', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}, {'title': 'Improvement', 'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Worsened', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Unchanged', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Not accessible', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}, {'value': '10', 'groupId': 'OG004'}]}], 'categories': [{'title': 'Remission', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}, {'title': 'Improvement', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}]}, {'title': 'Worsened', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Unchanged', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}, {'title': 'Not accessible', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}, {'title': 'Missing', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes. Here, Overall number of participants analyzed =Number of participants evaluable for this outcome measure. Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1516', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1044', 'groupId': 'OG000'}, {'value': '330', 'groupId': 'OG001'}, {'value': '229', 'groupId': 'OG002'}, {'value': '49', 'groupId': 'OG003'}, {'value': '67', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '13.70', 'spread': '43.8', 'groupId': 'OG000'}, {'value': '10.23', 'spread': '22.6', 'groupId': 'OG001'}, {'value': '8.79', 'spread': '17.0', 'groupId': 'OG002'}, {'value': '7.70', 'spread': '11.8', 'groupId': 'OG003'}, {'value': '12.18', 'spread': '30.7', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '933', 'groupId': 'OG000'}, {'value': '285', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}, {'value': '45', 'groupId': 'OG003'}, {'value': '66', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-1.09', 'spread': '47.4', 'groupId': 'OG000'}, {'value': '1.46', 'spread': '40.0', 'groupId': 'OG001'}, {'value': '-1.45', 'spread': '14.6', 'groupId': 'OG002'}, {'value': '-1.88', 'spread': '12.3', 'groupId': 'OG003'}, {'value': '0.94', 'spread': '32.8', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '678', 'groupId': 'OG000'}, {'value': '243', 'groupId': 'OG001'}, {'value': '166', 'groupId': 'OG002'}, {'value': '38', 'groupId': 'OG003'}, {'value': '55', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-4.87', 'spread': '38.6', 'groupId': 'OG000'}, {'value': '-2.23', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '-1.62', 'spread': '12.2', 'groupId': 'OG002'}, {'value': '3.88', 'spread': '25.4', 'groupId': 'OG003'}, {'value': '-4.84', 'spread': '30.7', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '428', 'groupId': 'OG000'}, {'value': '174', 'groupId': 'OG001'}, {'value': '122', 'groupId': 'OG002'}, {'value': '27', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-6.57', 'spread': '45.2', 'groupId': 'OG000'}, {'value': '0.63', 'spread': '37.7', 'groupId': 'OG001'}, {'value': '-2.45', 'spread': '11.7', 'groupId': 'OG002'}, {'value': '1.83', 'spread': '12.6', 'groupId': 'OG003'}, {'value': '-0.59', 'spread': '51.8', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '234', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '94', 'groupId': 'OG002'}, {'value': '21', 'groupId': 'OG003'}, {'value': '32', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '0.33', 'spread': '177.3', 'groupId': 'OG000'}, {'value': '-3.51', 'spread': '18.2', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '41.7', 'groupId': 'OG002'}, {'value': '4.17', 'spread': '24.6', 'groupId': 'OG003'}, {'value': '-3.11', 'spread': '19.6', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.', 'unitOfMeasure': 'milligram per liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1516', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '202', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '1066.31', 'spread': '5419.8', 'groupId': 'OG000'}, {'value': '556.88', 'spread': '916.2', 'groupId': 'OG001'}, {'value': '362.48', 'spread': '642.8', 'groupId': 'OG002'}, {'value': '616.03', 'spread': '1023.3', 'groupId': 'OG003'}, {'value': '537.58', 'spread': '1471.9', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-283.21', 'spread': '989.0', 'groupId': 'OG000'}, {'value': '-296.95', 'spread': '958.1', 'groupId': 'OG001'}, {'value': '-164.60', 'spread': '440.8', 'groupId': 'OG002'}, {'value': '-648.16', 'spread': '1333.1', 'groupId': 'OG003'}, {'value': '224.56', 'spread': '700.1', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-165.32', 'spread': '691.9', 'groupId': 'OG000'}, {'value': '361.51', 'spread': '1741.1', 'groupId': 'OG001'}, {'value': '-289.57', 'spread': '1004.9', 'groupId': 'OG002'}, {'value': '-382.73', 'spread': '503.1', 'groupId': 'OG003'}, {'value': '-643.67', 'spread': '2339.3', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-473.07', 'spread': '1394.3', 'groupId': 'OG000'}, {'value': '275.48', 'spread': '1518.0', 'groupId': 'OG001'}, {'value': '88.44', 'spread': '746.8', 'groupId': 'OG002'}, {'value': '-73.94', 'spread': '125.3', 'groupId': 'OG003'}, {'value': '109.16', 'spread': '164.4', 'groupId': 'OG004'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}]}], 'categories': [{'measurements': [{'value': '-625.69', 'spread': '1684.7', 'groupId': 'OG000'}, {'value': '-862.40', 'spread': '958.4', 'groupId': 'OG001'}, {'value': '-494.66', 'spread': '1226.4', 'groupId': 'OG002'}, {'value': '-13.35', 'spread': '273.4', 'groupId': 'OG003'}, {'value': '-450.98', 'spread': '200.2', 'groupId': 'OG004'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Months 6, 12, 18, and 24', 'description': "Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin.", 'unitOfMeasure': 'milligram per kilogram (mg/kg)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS=all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC). Here, Number analyzed =participants evaluable at specified time points for each arm.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Imaging Test Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1516', 'groupId': 'OG000'}, {'value': '492', 'groupId': 'OG001'}, {'value': '358', 'groupId': 'OG002'}, {'value': '67', 'groupId': 'OG003'}, {'value': '102', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'OG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'OG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'OG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'classes': [{'categories': [{'measurements': [{'value': '516', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '28', 'groupId': 'OG003'}, {'value': '50', 'groupId': 'OG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline up to follow-up period (a maximum of 2 years)', 'description': "Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS =all participants who received at least 1 dose of study drug and had at least one post-dose assessment of any of the effectiveness outcomes (clinical assessment of disease activity, laboratory and imaging results related to treatment or assessment of CD or UC).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'FG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'FG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'FG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'FG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1522'}, {'groupId': 'FG001', 'numSubjects': '494'}, {'groupId': 'FG002', 'numSubjects': '358'}, {'groupId': 'FG003', 'numSubjects': '67'}, {'groupId': 'FG004', 'numSubjects': '102'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1117'}, {'groupId': 'FG001', 'numSubjects': '393'}, {'groupId': 'FG002', 'numSubjects': '291'}, {'groupId': 'FG003', 'numSubjects': '60'}, {'groupId': 'FG004', 'numSubjects': '88'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '405'}, {'groupId': 'FG001', 'numSubjects': '101'}, {'groupId': 'FG002', 'numSubjects': '67'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '14'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '15'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '96'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '16'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Participant Non-compliant', 'reasons': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '145'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '24'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}]}, {'type': 'Missing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of 2565 participants were enrolled in the study, out of which 22 participants were not eligible to receive treatment for any of the treatment groups. Hence, only those participants who received treatment during the study observation period were included in the participants flow section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1522', 'groupId': 'BG000'}, {'value': '494', 'groupId': 'BG001'}, {'value': '358', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}, {'value': '102', 'groupId': 'BG004'}, {'value': '2543', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-P13', 'description': "Participants diagnosed with either Crohn's Disease (CD) or Ulcerative Colitis (UC), and who were biologic naive initiating CT-P13 and received CT-P13 continuously, or participants who were treated with CT-P13 continuously, or who were treated with CT-P13 then switched to other anti-tumor necrosis factors (TNFs) therapy except Remicade or non-biologic treatment during the study, or those who switched to CT-P13 from an alternative biologic therapy (except Remicade) due to non-responsiveness to or intolerance with existing therapy were enrolled in this group. Participants received CT-P13 continuously in accordance with usual clinical practice of Inflammatory bowel disease (IBD) at the discretion of the physician and observed for a duration of approximately 24 months."}, {'id': 'BG001', 'title': 'Remicade', 'description': 'Participants diagnosed with either CD or UC, and who were biologic naive initiating Remicade and received Remicade continuously, or participants who were treated with Remicade continuously, or who were treated with Remicade then switched to other anti-TNFs therapy (except CT-P13) or non-biologic treatment during the study, or those who switched to Remicade from an alternative biologic therapy (except CT-P13) due to non-responsiveness or intolerance were enrolled in this group. Participants received Remicade in accordance with usual clinical practice of IBD at the discretion of the physician and observed for a duration of approximately 24 months.'}, {'id': 'BG002', 'title': 'Switched From Remicade to CT-P13', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with Remicade continuously as per usual clinical practice of IBD, switched to CT-P13 once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'BG003', 'title': 'Switched From CT-P13 to Remicade', 'description': 'Participants diagnosed with either CD or UC and who were previously treated with CT-P13 continuously as per usual clinical practice of IBD, switched to Remicade once, either at enrollment or during the study were observed for a duration of approximately 24 months.'}, {'id': 'BG004', 'title': 'Multiple Switchers', 'description': 'Participants with CD or UC with at least 2 switches between Remicade and CT-P13 during the study, were observed for a duration of approximately 24 months. Both Remicade and CT-P13 were administered as per usual clinical practice of IBD.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '39.8', 'spread': '14.65', 'groupId': 'BG000'}, {'value': '38.8', 'spread': '12.74', 'groupId': 'BG001'}, {'value': '40.9', 'spread': '14.14', 'groupId': 'BG002'}, {'value': '41.1', 'spread': '13.96', 'groupId': 'BG003'}, {'value': '38.4', 'spread': '13.23', 'groupId': 'BG004'}, {'value': '39.8', 'spread': '13.74', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '750', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}, {'value': '48', 'groupId': 'BG004'}, {'value': '1218', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '772', 'groupId': 'BG000'}, {'value': '261', 'groupId': 'BG001'}, {'value': '200', 'groupId': 'BG002'}, {'value': '38', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '1325', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '1080', 'groupId': 'BG000'}, {'value': '391', 'groupId': 'BG001'}, {'value': '275', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '83', 'groupId': 'BG004'}, {'value': '1884', 'groupId': 'BG005'}]}, {'title': 'Other', 'measurements': [{'value': '267', 'groupId': 'BG000'}, {'value': '60', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '401', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '39', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '231', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With Medical History of Smoking', 'classes': [{'categories': [{'measurements': [{'value': '320', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}, {'value': '513', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With a History of Cancer', 'classes': [{'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With Stoma Status', 'classes': [{'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '65', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With a History Surgery', 'classes': [{'categories': [{'measurements': [{'value': '395', 'groupId': 'BG000'}, {'value': '165', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '32', 'groupId': 'BG004'}, {'value': '731', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Surgery status was a categorical variable defined as yes if the participant had prior surgical treatment related to the treatment of CD or UC.', 'unitOfMeasure': 'Participants'}, {'title': 'Participants With a History of Fistula Disease', 'classes': [{'categories': [{'measurements': [{'value': '304', 'groupId': 'BG000'}, {'value': '124', 'groupId': 'BG001'}, {'value': '86', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '561', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety analysis population included all participants who received at least 1 dose of study drug during the observation period.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-06', 'size': 2216441, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-22T12:01', 'hasProtocol': True}, {'date': '2018-10-08', 'size': 1151737, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-22T12:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2565}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-30', 'studyFirstSubmitDate': '2015-07-22', 'resultsFirstSubmitDate': '2019-10-22', 'studyFirstSubmitQcDate': '2015-08-31', 'lastUpdatePostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-30', 'studyFirstPostDateStruct': {'date': '2015-09-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease Characteristics of Participants: Disease Duration', 'timeFrame': 'Baseline (Day 1)', 'description': 'Disease duration was defined as the number of months from initial diagnosis of inflammatory bowel disease (CD or UC) to the date of informed consent, which was recorded at the time of enrollment into the study (baseline).'}, {'measure': 'Number of Participants Who Switched Treatment', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Here, number of participants with either UC or CD, who switched from remicade to CT-P13; switched from CT-P13 to remicade and multiple switchers were reported.'}, {'measure': 'Reasons for Switching Treatment by Participants', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)'}, {'measure': 'Total Dose of Infusion Received', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Total dose of infusion received by the participants was calculated.'}, {'measure': 'Number of Participants by Frequency of Infusion Received', 'timeFrame': 'Baseline (Day 1)', 'description': "Number of participants by infusion frequency (weeks) were reported at baseline and categorized as follows: once a week; once every 2 weeks; once every 3 weeks; once every 4 weeks; once every 5 weeks; once every 6 weeks; once every 7 weeks; once every 8 weeks and others. Here, 'Others' category included all the frequencies apart from the mentioned categories."}, {'measure': 'Number of Participants Who Had Change in Infusion Dose', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'Participants who had change in the dose of infusion (either dose reduction or increase in dose) were included and reported.'}, {'measure': 'Number of Participants Who Had Change in Infusion Dose Categorized Based on Reasons of Change', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': "Participants who had change in infusion dose due to various reasons such as principal investigator's decision, participant's decisions, loss of response, lack of compliance, hypersensitivity, occurrence of adverse event (including adverse event special interest \\[AESI\\]/ serious adverse event \\[SAE\\]), positive for antibodies and other were reported. Here, 'Others' category included all reasons apart from the mentioned categories. A participant could have different reasons of dose change across visits, hence could be counted in more than one category."}, {'measure': "Number of Participants Who Took Concomitant Medications Related to the Treatment of Crohn's Disease (CD) or Ulcerative Colitis (UC)", 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Event (AEs), Serious Adverse Events (SAEs) and Adverse Event With Special Interest (AESIs)', 'timeFrame': 'From baseline to follow-up period (up to a maximum duration of 2 years)', 'description': 'An AE was any untoward medical occurrence in a participant who received study treatment without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability or incapacity, congenital anomaly. Treatment-emergent were events between first dose of infusion up to month 24, that were absent before treatment or that worsened relative to pretreatment state. Hypersensitivity was the pre-defined TEAE of special Interest for this study. AEs included both serious and non-serious adverse events.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants Remaining in Clinical Remission or Relapse', 'timeFrame': 'Months 6, 12, 18 and 24', 'description': "Clinical remission in participants was defined by a total Mayo score of 2 points or lower, with no individual sub score exceeding 1 point. Mayo score is an instrument designed to measure disease activity. It consisted of 4 sub scores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician's global assessment, each sub score graded from 0 to 3 with higher scores indicating more severe disease. These scores were summed up to give a total score range of 0 to 12; where higher scores indicating more severe disease. The relapse of clinical remission was defined as the time from the date of first attaining CR to the date of relapse or death from any cause, whichever occurred first."}, {'measure': "Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index (HBI) According to Clinical Remission", 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'HBI is a simple index of CD activity. HBI measures 5 parameters; the general well-being (ranging from 0=very well to 4=terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (score less than \\[\\<\\] 5), mild disease (MD) (score equal to \\[=\\] 5 to 7), moderate disease (Mod D) (score=8 to 16) and severe disease (SD) (score more than \\[\\>\\] 16).'}, {'measure': "Crohn's Disease: Number of Participants With Shift From Baseline in Harvey Bradshaw Index According to Disease Activity", 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'HBI is a simple index of CD activity. HBI measures 5 clinical parameters; the general well-being ranging from 0 (very well) to 4 (terrible), abdominal pain ranging from 0 (none) to 3 (severe), number of liquid stools per day (no maximum score), presence of an abdominal mass on physical exam ranging from 0 (none) to 3 (definite and tender), and whether there are any complications ranging from 0=no complications, 1=Arthralgia; 2=Uveitis; 3=Erythema nodosum; 4=Aphthous ulcer; 5=Pyoderma gangrenosum; 6=Anal fissure; 7=New fistula and 8=abscess). The total HBI score is the sum of all the 5 individual parameters, the minimum score is 0 and there was no pre-specified maximum score as it depends on the number of liquids stools. Higher HBI scores=greater disease activity. The level of disease activity was interpreted as clinical remission (CR) (HBI score \\< 5), mild disease (MD) (HBI score = 5 to 7), moderate disease (Mod D) (HBI score = 8 to 16) and severe disease (SD) (HBI score \\>16).'}, {'measure': 'Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Clinical Remission', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores = more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having \\>=5 stools more than normal), the presence of rectal bleeding (ranging from 0=no blood seen to 3=blood alone passes), and physician's global assessment (ranging from 0=normal to 3=severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS \\<2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS \\>6)."}, {'measure': 'Ulcerative Colitis: Number of Participants With Shift From Baseline in Partial Mayo Scoring System According to Disease Activity', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "Mayo Score is an instrument to measure disease activity of UC. Score ranges from 0 to 12 points. It consists of 4 sub scores, each graded from 0 to 3. Higher scores= more severe disease. A Partial Mayo Score (PMS) (Mayo score without endoscopy) is comprised of 3 parameters: stool frequency ranging from 0 (normal number of stools) to 3 (having \\>=5 stools more than normal), the presence of rectal bleeding ranging from 0 (no blood seen) to 3 (blood alone passes), and physician's global assessment ranging from 0 (normal) to 3 (severe disease). The total partial Mayo score was the sum of all the parameters, score ranging from 0 (normal or inactive disease) to 9 (severe disease). Higher scores indicated more severe disease. The score was calculated if data were available for at least 1 of 3 Mayo sub scores. The level of disease activity was interpreted as clinical remission (CR) (PMS \\<2), mild disease (MD) (PMS=2 to 4), moderate disease (Mod D) (PMS=5 to 6) and severe disease (SD) (PMS \\>6)."}, {'measure': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Age at Diagnosis", 'timeFrame': 'At Baseline', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There were four different age groups categorized: 16 years or younger, 17-40 years, over 40 years and missing.'}, {'measure': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Location", 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consisted of three parameters: age at diagnosis, location and behavior of the disease activity. There are four different disease locations presented: Location 1 (L1) is terminal ileum, Location 2 (L2) is colon, Location 3 (L3) is ileocolon and Location 4 (L4) is upper gastrointestinal (GI). The first three categories (L1-L3) was combined with L4 where disease sites coexisted.'}, {'measure': "Crohn's Disease: Number of Participants Categorized on the Basis of Montreal Classification Index by Behavior of the Disease Activity", 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for CD was used to classify the extent of the disease activity. It consists of two parameters: location and behavior of the disease activity. There were 4 different categories for the behavior of the disease activity: Behaviour 1 (B1) was nonstricturing (NS), nonpenetrating (NP); Behaviour 2 (B2) was structuring; Behaviour 3 (B3) was penetrating and p as perianal disease (p). The first 3 categories (B1 to B3) could be added with p to indicate coexisting perianal disease. Perianal disease (p) was defined as the presence of perianal abscesses or fistulae.'}, {'measure': 'Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Extent', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for Ulcerative Colitis (UC) was used to classify the extent and severity of the disease activity. There were three subgroups of UC defined by extent: Extent 1 (E1) =Ulcerative proctitis, Extent 2 (E2) =Left-sided UC and Extent 3 (E3) =Extensive UC.'}, {'measure': 'Ulcerative Colitis: Number of Participants Categorized on the Basis of Montreal Classification Index by Severity', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'The Montreal classification index for UC was used to classify the extent and severity of the disease activity. UC can be classified broadly into four disease activity/severity categories: Severity 0 (S0) = asymptomatic clinical remission; Severity 1 (S1) = Mild UC (passage of four or fewer stools/day \\[with or without blood\\], absence of any systemic illness, and normal inflammatory markers); Severity 2 (S2) = Moderate UC (passage of more than four stools per day but with minimal signs of systemic toxicity) and Severity 3 (S3) = Severe UC (passage of at least six bloody stools daily).'}, {'measure': "Crohn's Disease: Number of Participants Categorized on the Basis of Fistula Drainage Assessment Index", 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': "The fistula drainage assessment index was used to assess the improvement or remission of the disease activity of Crohn's Disease, based on 6 categories: remission (remission was defined as closure of all fistulae that were draining at baseline for at least two consecutive visits); improvement (improvement defined as a decrease from baseline in the number of open draining fistulae of 50% for at least two consecutive visits); worsened; unchanged; not accessible and missing disease activity."}, {'measure': 'Mean Change From Baseline in Laboratory Test Results: C-Reactive Protein at Months 6, 12, 18, and 24', 'timeFrame': 'Baseline, Months 6, 12, 18 and 24', 'description': 'C-reactive protein (CRP) was a laboratory measurement for evaluation of an acute phase reactant of inflammation through the use of an ultra-sensitive assay. A decrease in the level of CRP indicated reduction in inflammation and therefore improvement.'}, {'measure': 'Mean Change From Baseline in Laboratory Test Results: Fecal Calprotectin at Months 6, 12, 18, and 24', 'timeFrame': 'Baseline, Months 6, 12, 18, and 24', 'description': "Here, the laboratory tests related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis was fecal calprotectin."}, {'measure': 'Number of Participants With Imaging Test Results', 'timeFrame': 'From baseline up to follow-up period (a maximum of 2 years)', 'description': "Number of participants who had Imaging test results related to the treatment or assessment of Crohn's Disease or Ulcerative Colitis were reported."}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CT-P13', 'Inflectra', 'Remicade', 'Infliximab', 'Observational', 'Follow-up', 'Safety', 'Effectiveness'], 'conditions': ['Inflammatory Bowel Diseases', 'Ulcerative Colitis', "Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '37038897', 'type': 'DERIVED', 'citation': 'Bokemeyer B, Hlavaty T, Allez M, Selema P, Moosavi S, Cadatal MJ, Fowler H, Mueller M, Liau KF, Gisbert JP. Real-world observational cohort study of treatment patterns and safety outcomes of infliximab biosimilar CT-P13 for the treatment of inflammatory bowel disease (CONNECT-IBD). Expert Opin Biol Ther. 2023 Jul-Dec;23(8):791-800. doi: 10.1080/14712598.2023.2200883. Epub 2023 Apr 16.'}]}, 'descriptionModule': {'briefSummary': "This is a post-marketing observational study of patients with Inflammatory Bowel Disease (specifically, Crohn's disease or Ulcerative Colitis) who have been prescribed CT-P13 (infliximab) or Remicade (infliximab) for treatment. CT-P13 (brand names Inflectra and Remsima) is a biosimilar medicine to Remicade, meaning it is a biologic medicine that contains the same active substance as Remicade (infliximab). The key study objectives are as follows:\n\n* To characterize the population and drug utilization patterns of patients treated with CT-P13 for Crohn's Disease (CD) or Ulcerative Colitis (UC) in the context of standard of care Remicade\n* To explore the long-term safety profile of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade\n* To assess the effectiveness of CT-P13 in the treatment of patients with CD or UC in the context of standard of care Remicade", 'detailedDescription': 'The study will be conducted in accordance with legal and regulatory requirements with scientific purpose, value and rigor following generally accepted research practices described in Guidelines for Good Pharmacoepidemiology Practices (GPP), Good Epidemiological Practice (GEP), Good Practices for Outcomes Research, International Ethical Guidelines for Epidemiological Research, European Medicines Agency (EMA) European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) Guide on Methodological Standards in Pharmacoepidemiology, and FDA Guidance for Industry. Data sources will be validated and will consist of the hospital medical records and monitoring will be organized on a regular basis. Data for the study will be entered into a web based electronic data capture (EDC) system at enrolment and then approximately every 3 months (at a minimum) thereafter up to 2 years. Adverse events will be encoded according to MedDRA 17.1 or later. The sample size will be approximately 2500 patients recruited over a 30 month period and followed up to 2 years. No inferential analyses are planned. Statistical analysis will be descriptive in nature.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The target study population will include patients with CD or UC, who are being treated, or initiating treatment, with CT-P13 or Remicade at the time of study enrolment. This would include the following treatment subgroups:\n\n* Biologic-naïve patients initiating CT-P13 (or Remicade);\n* Patients currently being treated with CT-P13 (or Remicade);\n* Patients who are considered stable by the Investigator under Remicade therapy for CD or UC, who switch to CT-P13;\n* Patients switching to CT-P13 or Remicade from an alternative biologic therapy (e.g. adalimumab) due to non-responsiveness to or intolerance;\n* Patients re-initiating CT-P13 or Remicade after having successfully completed and exited a previous course of infliximab therapy in the past.\n* Patients with fistulating disease or stomas and those receiving combination therapy will be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. At least 12 years of age at the time of initial confirmed diagnosis of CD or UC and at least 18 years of age at the time of enrolment to the study.\n2. Patients who are prescribed CT-P13 or Remicade for the treatment of CD or UC prescribed according to the corresponding summary of product characteristics (SmPC) as determined by the Investigator. Patients with stomas or surgery/pouch will be included.\n\nExclusion Criteria:\n\n1. Any reported contraindications for CT-P13 or Remicade, according to the SmPC.\n2. Known hypersensitivity (including severe, acute infusion reactions) to infliximab, its excipients or other murine proteins, at the time of enrolment.\n3. Prior history of failure to respond to Remicade or CT-P13.'}, 'identificationModule': {'nctId': 'NCT02539368', 'acronym': 'CONNECT-IBD', 'briefTitle': 'Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'POST-MARKETING OBSERVATIONAL COHORT STUDY OF PATIENTS WITH INFLAMMATORY BOWEL DISEASE (IBD) TREATED WITH CT-P13 IN USUAL CLINICAL PRACTICE (CONNECT-IBD)', 'orgStudyIdInfo': {'id': 'ZOB INF 1402'}, 'secondaryIdInfos': [{'id': 'C1231001', 'type': 'OTHER', 'domain': 'Alias Study Number'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'CT-P13', 'description': 'biosimilar infliximab', 'interventionNames': ['Drug: CT-P13']}, {'label': 'Remicade', 'description': 'infliximab', 'interventionNames': ['Drug: Remicade']}], 'interventions': [{'name': 'CT-P13', 'type': 'DRUG', 'otherNames': ['Inflectra', 'Remsima'], 'description': 'biosimilar infliximab', 'armGroupLabels': ['CT-P13']}, {'name': 'Remicade', 'type': 'DRUG', 'description': 'infliximab', 'armGroupLabels': ['Remicade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3000', 'city': 'Leuven', 'state': 'Vlaams Brabant', 'country': 'Belgium', 'facility': 'UZ Leuven Campus Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '2650', 'city': 'Edegem', 'country': 'Belgium', 'facility': 'UZ Antwerpen', 'geoPoint': {'lat': 51.15662, 'lon': 4.44504}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni Nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '500 12', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Hradecká Poliklinika III, HEPATO-GASTROENTEROLOGIE HK, s.r.o', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '703 84', 'city': 'Ostrava - Vitkovice', 'country': 'Czechia', 'facility': 'Centrum péce o zažívací trakt, Vítkovická nemocnice'}, {'zip': '140 21', 'city': 'Prague', 'country': 'Czechia', 'facility': 'IKEM (Institut Klinické a Experimentální Medicíny)', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180 81', 'city': 'Praha 8 Liben', 'country': 'Czechia', 'facility': 'Nemocnice Na Bulovce'}, {'zip': 'FI-40620', 'city': 'Jyväskylä', 'country': 'Finland', 'facility': 'Keski-Suomen keskussairaala', 'geoPoint': {'lat': 62.24147, 'lon': 25.72088}}, {'zip': '90220', 'city': 'Oulu', 'country': 'Finland', 'facility': 'Oulu University Hospital', 'geoPoint': {'lat': 65.01236, 'lon': 25.46816}}, {'zip': '20521', 'city': 'Turku', 'country': 'Finland', 'facility': 'Turku University Hospital', 'geoPoint': {'lat': 60.45148, 'lon': 22.26869}}, {'zip': '80054', 'city': 'Amiens', 'country': 'France', 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}, {'zip': '49933', 'city': 'Angers', 'country': 'France', 'facility': 'CHU Angers', 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '25030', 'city': 'Besançon', 'country': 'France', 'facility': 'CHRU de Besancon', 'geoPoint': {'lat': 47.24878, 'lon': 6.01815}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '94220', 'city': 'Charenton', 'country': 'France', 'facility': 'Clinique de Bercy', 'geoPoint': {'lat': 47.26971, 'lon': 2.98333}}, {'zip': '63003', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermontferrand', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hopital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '92700', 'city': 'Colombes', 'country': 'France', 'facility': 'Hôpital Louis Mourier', 'geoPoint': {'lat': 48.91882, 'lon': 2.25404}}, {'zip': '38043', 'city': 'Grenoble', 'country': 'France', 'facility': 'CHU de Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '59000', 'city': 'Lille', 'country': 'France', 'facility': 'CHRU', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'zip': '69003', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Edouard Herriot Pav H', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '13003', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Europeen', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '13015', 'city': 'Marseille', 'country': 'France', 'facility': 'Hopital Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '30029/Cedex 9', 'city': 'Nîmes', 'country': 'France', 'facility': 'CHU Nimes', 'geoPoint': {'lat': 43.83665, 'lon': 4.35788}}, {'zip': '75012', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Saint-Antoine, AP-HP, Universite Pierre-et-Marie-Curie', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75014', 'city': 'Paris', 'country': 'France', 'facility': 'Institut Montsouris', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Européen Georges Pompidou', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75475', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital St Louis', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'CHU Lyon Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '74374', 'city': 'Pringy', 'country': 'France', 'facility': 'Hopital Metz Tessy', 'geoPoint': {'lat': 45.94622, 'lon': 6.12608}}, {'zip': '51000', 'city': 'Reims', 'country': 'France', 'facility': 'Hopital Robert Debre', 'geoPoint': {'lat': 49.26526, 'lon': 4.02853}}, {'zip': '76031', 'city': 'Rouen', 'country': 'France', 'facility': 'Chu Ch.Nicolle', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}, {'zip': '42270', 'city': 'Saint Priez En Jarez', 'country': 'France', 'facility': 'Service: CHU saint-etienne'}, {'zip': '67098', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Centre Hospitalier Universitaire', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'CHU Rangueil', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '31059', 'city': 'Toulouse', 'country': 'France', 'facility': 'Hopital Purpan', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'CHU Nancy', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '69694', 'city': 'Vénissieux', 'country': 'France', 'facility': 'Groupe hospitalier mutualiste les portes du Sud', 'geoPoint': {'lat': 45.69706, 'lon': 4.88593}}, {'zip': '67076', 'city': 'Ludwigshafen am Rhein', 'state': 'Gartenstadt', 'country': 'Germany', 'facility': 'St. Marienkrankenhaus', 'geoPoint': {'lat': 49.48121, 'lon': 8.44641}}, {'zip': '24161', 'city': 'Altenholz', 'country': 'Germany', 'facility': 'Gemeinschaftspraxis im MEDICUM', 'geoPoint': {'lat': 54.39793, 'lon': 10.1279}}, {'zip': '55232', 'city': 'Alzey', 'country': 'Germany', 'facility': 'Gastroenterologische Praxis Dr. med. 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