Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2026-01-03 @ 11:26 PM
Study NCT ID:
NCT02260804
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2014-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000626854', 'term': 'CT-P10'}, {'id': 'D000069283', 'term': 'Rituximab'}], 'ancestors': [{'id': 'D058846', 'term': 'Antibodies, Monoclonal, Murine-Derived'}, {'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': 'contact@celltrion.com', 'phone': '+82-32-850-5000', 'title': 'Dr. Sung Hyun Kim', 'organization': 'CELLTRION, Inc.'}, 'certainAgreement': {'otherDetails': 'A confidentiality and non-disclosure agreement (CDA) was executed between Celltrion, Inc. and some PIs who have participated in publications funded by the sponsor for academic purposes for a period that is more than 180 days from the time submitted to the sponsor for review.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'In this study, TTE endpoints were secondary endpoints and were not powered. As medians of PFS, TTP, and OS were not reached in both treatment groups, longer follow-up is needed to ascertain the median time for TTE parameters of PFS, TTP, and OS.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and Serious adverse events (SAEs) were to be collected from the date the ICF was signed until up to 30 days from the last dose of the study drug, regardless of the relationship to the study drug. data from the overall study period (median follow-up of 29.2 months) are presented.', 'eventGroups': [{'id': 'EG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period', 'otherNumAtRisk': 130, 'deathsNumAtRisk': 130, 'otherNumAffected': 93, 'seriousNumAtRisk': 130, 'deathsNumAffected': 3, 'seriousNumAffected': 14}, {'id': 'EG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.', 'otherNumAtRisk': 128, 'deathsNumAtRisk': 128, 'otherNumAffected': 86, 'seriousNumAtRisk': 128, 'deathsNumAffected': 3, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 13}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Herpes virus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 31}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 29}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 13}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 42}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 39}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 7}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 6}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'seriousEvents': [{'term': 'Angina unstable', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Hyperparathyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastric haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Intestinal polyp', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Peptic ulcer perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Nasal neoplasm benign', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Squamous cell carcinoma of lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Genital prolapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}, {'term': 'Gastrointestinal surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 130, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 128, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 18.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Endpoint - Overall Response Rate by 7 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '108', 'groupId': 'OG000'}, {'value': '104', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'paramType': 'Difference in proportion', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.8', 'ciLowerLimit': '-6.43', 'ciUpperLimit': '10.2', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'The equivalence margin of ±17% was predefined.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'During the Month 7 (up to Maintenance Cycle 3; Week 28)', 'description': 'ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.\n\nPer 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \\>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint - ORR Over the Study Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'categories': [{'measurements': [{'value': '109', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 27 months', 'description': 'ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).\n\nPer 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \\>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.'}, {'type': 'SECONDARY', 'title': 'Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '123', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.0', 'groupId': 'OG000', 'lowerLimit': '56.0', 'upperLimit': '171.5'}, {'value': '120.0', 'groupId': 'OG001', 'lowerLimit': '64.0', 'upperLimit': '182.0'}]}]}, {'title': 'Induction Cycle 1 (1hr after end of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '114', 'groupId': 'OG000'}, {'value': '111', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Induction Cycle 2 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Induction Cycle 3 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '124', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Induction Cycle 4 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '121', 'groupId': 'OG000'}, {'value': '122', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'EOT1 (anytime)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Maintenance Cycle 1 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '113', 'groupId': 'OG000'}, {'value': '121', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Maintenance Cycle 1 (1hr after end of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Maintenance Cycle 2 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Maintenance Cycle 2 (1hr after end of infusion)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '107', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}, {'title': 'Maintenance Cycle 3 (predose)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG000', 'lowerLimit': '20.0', 'upperLimit': '20.0'}, {'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '20.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).', 'description': 'B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.', 'unitOfMeasure': 'cells/uL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PD population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PD result.'}, {'type': 'SECONDARY', 'title': 'Secondary PK Endpoints - Cmax', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': 'Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '212.86', 'spread': '50.64', 'groupId': 'OG000'}, {'value': '217.38', 'spread': '56.33', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '283.35', 'spread': '53.84', 'groupId': 'OG000'}, {'value': '285.98', 'spread': '62.26', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '327.32', 'spread': '71.05', 'groupId': 'OG000'}, {'value': '341.59', 'spread': '77.95', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '373.46', 'spread': '70.50', 'groupId': 'OG000'}, {'value': '383.05', 'spread': '83.86', 'groupId': 'OG001'}]}]}, {'title': 'Maintenance Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '256.97', 'spread': '65.61', 'groupId': 'OG000'}, {'value': '265.03', 'spread': '53.73', 'groupId': 'OG001'}]}]}, {'title': 'Maintenance Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '119', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '239.70', 'spread': '65.72', 'groupId': 'OG000'}, {'value': '249.86', 'spread': '69.02', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.'}, {'type': 'SECONDARY', 'title': 'Secondary PK Endpoints - Ctrough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': 'Induction Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '126', 'groupId': 'OG000'}, {'value': '127', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64.66', 'spread': '24.88', 'groupId': 'OG000'}, {'value': '72.94', 'spread': '40.39', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '113.23', 'spread': '34.60', 'groupId': 'OG000'}, {'value': '120.92', 'spread': '36.02', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '149.53', 'spread': '43.65', 'groupId': 'OG000'}, {'value': '161.80', 'spread': '43.91', 'groupId': 'OG001'}]}]}, {'title': 'Induction Cycle 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '34.78', 'spread': '33.58', 'groupId': 'OG000'}, {'value': '31.38', 'spread': '19.15', 'groupId': 'OG001'}]}]}, {'title': 'Maintenance Cycle 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '120', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.68', 'spread': '37.22', 'groupId': 'OG000'}, {'value': '21.35', 'spread': '20.90', 'groupId': 'OG001'}]}]}, {'title': 'Maintenance Cycle 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.96', 'spread': '9.61', 'groupId': 'OG000'}, {'value': '18.37', 'spread': '10.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)', 'unitOfMeasure': 'μg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK population consisted of all patients who received at least 1 dose (full) of study drug and had at least 1 posttreatment PK result.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint - Progression-free Survival (PFS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '0.93', 'groupId': 'OG000', 'lowerLimit': '0.87', 'upperLimit': '0.96'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.82', 'upperLimit': '0.93'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.88', 'groupId': 'OG000', 'lowerLimit': '0.81', 'upperLimit': '0.92'}, {'value': '0.83', 'groupId': 'OG001', 'lowerLimit': '0.75', 'upperLimit': '0.89'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.80', 'groupId': 'OG000', 'lowerLimit': '0.70', 'upperLimit': '0.87'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).', 'description': 'PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint - Overall Survival (OS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '0.99'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.94', 'upperLimit': '1.00'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '0.99'}, {'value': '0.98', 'groupId': 'OG001', 'lowerLimit': '0.94', 'upperLimit': '1.00'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '0.99'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '0.99'}]}]}, {'title': '42 months', 'categories': [{'measurements': [{'value': '0.98', 'groupId': 'OG000', 'lowerLimit': '0.93', 'upperLimit': '0.99'}, {'value': '0.97', 'groupId': 'OG001', 'lowerLimit': '0.89', 'upperLimit': '0.99'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study period (median follow-up of 29.2 months)', 'description': 'Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint - Time-to Progression (TTP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '128', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'OG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'classes': [{'title': '12 months', 'categories': [{'measurements': [{'value': '0.94', 'groupId': 'OG000', 'lowerLimit': '0.88', 'upperLimit': '0.97'}, {'value': '0.89', 'groupId': 'OG001', 'lowerLimit': '0.83', 'upperLimit': '0.94'}]}]}, {'title': '24 months', 'categories': [{'measurements': [{'value': '0.89', 'groupId': 'OG000', 'lowerLimit': '0.82', 'upperLimit': '0.94'}, {'value': '0.84', 'groupId': 'OG001', 'lowerLimit': '0.76', 'upperLimit': '0.89'}]}]}, {'title': '36 months', 'categories': [{'measurements': [{'value': '0.82', 'groupId': 'OG000', 'lowerLimit': '0.72', 'upperLimit': '0.88'}, {'value': '0.68', 'groupId': 'OG001', 'lowerLimit': '0.54', 'upperLimit': '0.79'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).', 'description': 'Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.', 'unitOfMeasure': 'Proportion of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The ITT population consisted of all patients enrolled and randomly assigned to receive a study drug, regardless of whether or not any study drug dosing was completed.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'FG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}], 'periods': [{'title': 'Induction Study Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '128'}, {'groupId': 'FG001', 'numSubjects': '128'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': '1st Year of the Maintenance Period (MP1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Five subjects completed the induction period but did not initiate this period in the CT-P10 group.', 'groupId': 'FG000', 'numSubjects': '123'}, {'comment': 'Eight subjects completed the induction period but did not initiate this period in the Rituxan group.', 'groupId': 'FG001', 'numSubjects': '120'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '111'}, {'groupId': 'FG001', 'numSubjects': '105'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '15'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}, {'title': '2nd Year of the Maintenance Period (MP2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'One subject completed the MP1 but did not initiate this period in the CT-P10 group.', 'groupId': 'FG000', 'numSubjects': '110'}, {'comment': 'Two subjects completed the MP1 but did not initiate this period in the Rituxan group.', 'groupId': 'FG001', 'numSubjects': '103'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '101'}, {'groupId': 'FG001', 'numSubjects': '97'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 402 participants were screened for the study. Of those, 144 participants failed screening and 258 participants were enrolled in the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '258', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'CT-P10', 'description': 'CT-P10 375mg/m2, IV, 4 cycles in induction period and additional 12 cycles in maintenance period'}, {'id': 'BG001', 'title': 'Rituxan', 'description': 'Rituxan, 375mg/m2, IV, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57.7', 'spread': '12.68', 'groupId': 'BG000'}, {'value': '57.7', 'spread': '11.53', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '12.10', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '135', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '66', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '226', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-28', 'size': 225312, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-01-11T01:14', 'hasProtocol': True}, {'date': '2019-10-17', 'size': 2804958, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-01-12T00:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 258}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2019-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2014-10-05', 'resultsFirstSubmitDate': '2021-01-21', 'studyFirstSubmitQcDate': '2014-10-06', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-03-16', 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Efficacy Endpoint - Overall Response Rate by 7 Months', 'timeFrame': 'During the Month 7 (up to Maintenance Cycle 3; Week 28)', 'description': 'ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR) by central review.\n\nPer 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \\>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy Endpoint - ORR Over the Study Period', 'timeFrame': 'up to 27 months', 'description': 'ORR was defined as the proportion of patients with the best response of complete response (CR), unconfirmed CR (CRu), or partial response (PR).\n\nPer 1999 IWG criteria, the disease status was assessed by using contrasted CT and/or MRI, and CR, CRu, and PR were defined as followings; CR=Disappearance of all clinical/radiographic evidence of disease: regression of lymph nodes to normal size, absence of B-symptoms, bone marrow involvement, and organomegaly, and normal LDH level; CRu=Regression of measurable disease: \\>75% decrease in SPD of target lesions and in each target lesions. no increase in the size of non-target lesions, neither new lesion nor organomegaly measured; PR=Regression of measurable disease: ≥50% decrease in SPD of target lesions and no evidence of disease progression.'}, {'measure': 'Secondary PD Endpoint - B-cell Kinetics (B-cell Depletion and Recovery)', 'timeFrame': 'Baseline, Induction Cycle 1 (predose, 1 hr postdose), Induction Cycle 2 to 4 (predose), EOT1/EOT2 (anytime), Maintenance Cycle 1 to 2 (predose, 1hr postdose) and Maintenance Cycle 3 (predose).', 'description': 'B-cell kinetics were demonstrated by median values of B-cell counts. Any values below the LLoQ were set as LLoQ which was 20 cells/μL.'}, {'measure': 'Secondary PK Endpoints - Cmax', 'timeFrame': '1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)'}, {'measure': 'Secondary PK Endpoints - Ctrough', 'timeFrame': '1, 2, 3, 4, 12, 20 weeks (predose, 1 hr post dose), EOT1/EOT2 (anytime during the day) and 28 week (predose)'}, {'measure': 'Secondary Efficacy Endpoint - Progression-free Survival (PFS)', 'timeFrame': 'Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).', 'description': 'PFS was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death from any cause, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.'}, {'measure': 'Secondary Efficacy Endpoint - Overall Survival (OS)', 'timeFrame': 'Overall study period (median follow-up of 29.2 months)', 'description': 'Overall survival was defined as the interval between randomization and death from any cause. Locally reviewed data was used for the secondary efficacy analyses.'}, {'measure': 'Secondary Efficacy Endpoint - Time-to Progression (TTP)', 'timeFrame': 'Overall study period (Baseline, Month 3, 7, 13, 19 27, and every 6 months thereafter).', 'description': 'Time to progression was defined as the interval between randomization and disease progression/relapse by IWG 1999 (at least a 50% increase of any single nodal after smallest decrease) or death as a result of lymphoma, whichever occurred first. Locally reviewed data was used for the secondary efficacy analyses.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Follicular Lymphoma']}, 'referencesModule': {'references': [{'pmid': '34686445', 'type': 'DERIVED', 'citation': 'Kwak LW, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Menne T, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Ogura M, Kim WS, Lee SJ, Kim SH, Ahn KY, Buske C. Efficacy and Safety of CT-P10 Versus Rituximab in Untreated Low-Tumor-Burden Follicular Lymphoma: Final Results of a Randomized Phase III Study. Clin Lymphoma Myeloma Leuk. 2022 Feb;22(2):89-97. doi: 10.1016/j.clml.2021.08.005. Epub 2021 Aug 28.'}, {'pmid': '30389036', 'type': 'DERIVED', 'citation': 'Ogura M, Sancho JM, Cho SG, Nakazawa H, Suzumiya J, Tumyan G, Kim JS, Lennard A, Mariz J, Ilyin N, Jurczak W, Lopez Martinez A, Samoilova O, Zhavrid E, Yanez Ruiz E, Trneny M, Popplewell L, Coiffier B, Buske C, Kim WS, Lee SJ, Lee SY, Bae YJ, Kwak LW. Efficacy, pharmacokinetics, and safety of the biosimilar CT-P10 in comparison with rituximab in patients with previously untreated low-tumour-burden follicular lymphoma: a randomised, double-blind, parallel-group, phase 3 trial. Lancet Haematol. 2018 Nov;5(11):e543-e553. doi: 10.1016/S2352-3026(18)30157-1.'}], 'seeAlsoLinks': [{'url': 'http://www.celltrion.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'To demonstrate that CT-P10 is similar to Rituxan in terms of efficacy as determined by overall response rate at 7 months'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of low tumour burden, CD20+ follicular lymphoma\n* Ann Arbor Stage II, III or IV\n\nExclusion Criteria:\n\n* Has receive rituximab\n* Allergies or hypersensitivity to murine, chimeric, human or humanised proteins\n* Previous treatment for NHL\n* Any malignancy\n* Current or recent treatment with any other investigational medicinal product or device\n* pregnant or lactating'}, 'identificationModule': {'nctId': 'NCT02260804', 'briefTitle': 'To Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Celltrion'}, 'officialTitle': 'A Phase 3, Randomised, Parallel-group, Active-controlled, Double-blind Study to Compare Efficacy and Safety Between CT-P10 and Rituxan in Patients With Low Tumour Burden Follicular Lymphoma', 'orgStudyIdInfo': {'id': 'CT-P10 3.4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CT-P10', 'description': 'CT-P10, intervention 375mg/m2, intravenous, 4 cycles in induction period and additional 12 cycles in maintenance period', 'interventionNames': ['Biological: CT-P10']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Rituxan', 'description': 'Rituxan, 375mg/m2 intravenous, 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.', 'interventionNames': ['Biological: Rituxan']}], 'interventions': [{'name': 'CT-P10', 'type': 'BIOLOGICAL', 'description': '375mg/m2, IV on day1 of 4 cycles in induction period, and 12 cycles in maintenance period.', 'armGroupLabels': ['CT-P10']}, {'name': 'Rituxan', 'type': 'BIOLOGICAL', 'description': '375mg/m2, IV on day1 of 4 cycles in induction period, Rituxan for the first 6 cycles and CT-P10 for the last 6 cycles in maintenance period.', 'armGroupLabels': ['Rituxan']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'SungHyun Kim', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Celltrion'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Celltrion', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}