Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-04 @ 9:20 AM
Study NCT ID:
NCT02822235
Status:
COMPLETED
Last Update Posted:
2020-02-25
First Post:
2016-06-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'trialdisclosures@takeda.com', 'phone': '+1-877-825-3327', 'title': 'Medical Director', 'organization': 'Takeda'}, 'certainAgreement': {'otherDetails': 'The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Missing data on paticipants medical records in retrospective analysis and missing information in medical activity scores of participants in prospective analysis resulted in improper collection of data for IBD participants.'}}, 'adverseEventsModule': {'timeFrame': 'Up to Month 12', 'description': 'Data of adverse events or adverse drug reactions were not collected as part of the study database.', 'eventGroups': [{'id': 'EG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 264, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Percentage of Participants With Active Crohn's Disease (CD) at Day 1", 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'HBI Score ≥8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.52', 'groupId': 'OG000'}]}]}, {'title': 'CDAI Score ≥220', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '25.97', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with CD from cross-sectional population were analyzed for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Active Ulcerative Colitis (UC) at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': "Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).", 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Participants with UC from cross-sectional population were analyzed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Age ≥18-39 years old', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Age ≥40-59 years old', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Age ≥ 60 years old', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Gender, Male', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Gender, Female', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Employed', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unemployed', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Student', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Retired', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Other', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unknown', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Family History of IBD', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Not Literate', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Primary School', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Primary School Not Completed', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Secondary School', 'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Secondary School Not Completed', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Higher Education', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Higher Education Not Completed', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Post-Graduate/MBA', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Educational Level, Unknown', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Income, >10-20 MS (R$ 8.800,01 - R$ 17.600,00)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Income, >5-10 MS (R$ 4.400,01 - R$ 8.800,00)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Income, >3-5 MS (R$ 2.640,01 - R$ 4.440,00)', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Income, >2-3 MS (R$ 1.760,01 - R$ 2.640,00)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Income, >1-2 MS (R$ 880,01 - R$ 1.760,00)', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Income, >½-1 MS (R$ 440,01 - R$ 880,00)', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Income, ≤½ MS (Until R$ 440,00 (Including))', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Income, No Income', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Income, Unknown', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Income, Not Informed', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'CD or UC, Moderate to Severe Activity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}]}, {'title': 'Height (cm)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not collected according to the pre-defined categories.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data was not collected according to the pre-defined categories.', 'groupId': 'OG001'}]}]}, {'title': 'Weight (kg)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': 'NA', 'comment': 'Data was not collected according to the pre-defined categories.', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Data was not collected according to the pre-defined categories.', 'groupId': 'OG001'}]}]}, {'title': 'BMI - <24 Kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'BMI - 25 - 30 Kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'BMI - ≥30 Kg/m^2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Family History of IBD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Never Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Former Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Medical History, Comorbidity or EIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'Location of CD, L1+L4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Location of CD, L2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}]}]}, {'title': 'Location of CD, L3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}]}]}, {'title': 'Location of CD, L3+L4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B1+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B2+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Behavior, B3+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': 'Extent Inflammation, E1-Distal: Proctitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Extent Inflammation, E1-Distal: Proctosigmoiditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Inflammation, E2-Left-sided', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Inflammation, E3-Pancolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S1-Mild UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S2-Moderate UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S3-Severe UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-dependent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-refractory Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Colonoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Calprotectin >200ug/g', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': 'NA', 'comment': 'Calprotectin levels was not applicable for UC participants as established in the protocol.', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; anthropometric (Height, Weight and BMI); Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g, Eligibility for 12-month follow-up.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Salycyclic Derivates', 'categories': [{'measurements': [{'value': '16.9', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}, {'title': 'Corticosteroids', 'categories': [{'measurements': [{'value': '14.4', 'groupId': 'OG000'}, {'value': '36.1', 'groupId': 'OG001'}]}]}, {'title': 'Immunosuppresors', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000'}, {'value': '47.2', 'groupId': 'OG001'}]}]}, {'title': 'Biologic Therapy', 'categories': [{'measurements': [{'value': '66.9', 'groupId': 'OG000'}, {'value': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'Antibiotics', 'categories': [{'measurements': [{'value': '9.3', 'groupId': 'OG000'}, {'value': '13.9', 'groupId': 'OG001'}]}]}, {'title': 'Surgeries', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Others', 'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the previous 3 years including Day 1', 'description': 'Therapies for IBD included aminosalicylates, steroids, immunossupressors, biologics, antibiotics, surgeries and others. One participant could use more than one therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Infliximab', 'categories': [{'measurements': [{'value': '33.1', 'groupId': 'OG000'}, {'value': '16.7', 'groupId': 'OG001'}]}]}, {'title': 'Adalimumab', 'categories': [{'measurements': [{'value': '30.5', 'groupId': 'OG000'}, {'value': '11.1', 'groupId': 'OG001'}]}]}, {'title': 'Vedolizumab', 'categories': [{'measurements': [{'value': '2.5', 'groupId': 'OG000'}, {'value': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'Certolizumab', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Ustekimumab', 'categories': [{'measurements': [{'value': '0.8', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within the previous 3 years including Day 1', 'description': 'IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. One participant could use more than one biologic therapy.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.4', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.1', 'groupId': 'OG000'}, {'value': '88.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': "Crohn's Disease (Mild or No Activity)", 'description': "Participants with diagnosis of mild Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1."}], 'classes': [{'title': 'Gender, Male', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}, {'title': 'Gender, Female', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Employed', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '65', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unemployed', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Student', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Retired', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Other', 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unknown', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographic variables included gender and professional status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': "Crohn's Disease (Mild or No Activity)", 'description': "Participants with diagnosis of mild Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1."}], 'classes': [{'title': 'Family History of IBD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Never Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '84', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Former Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Medical History, Comorbidity or EIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '66', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L1+L4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Location of CD, L3+L4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '141', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B1+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B2+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, B3+P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}]}, {'title': 'Behavior, P', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-dependent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-refractory disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Colonoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '104', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}]}, {'title': 'Calprotectin >200ug/g', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '41', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': "Crohn's Disease (Mild or No Activity)", 'description': "Participants with diagnosis of mild Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1."}], 'classes': [{'title': 'Type of Therapy, Salicylic Derivates', 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Corticosteroids', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Immunosuppressors', 'categories': [{'measurements': [{'value': '80', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Biologic Therapy', 'categories': [{'measurements': [{'value': '79', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Antibiotics', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Other', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Previous Surgery', 'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Treatment variables included previous treatments or regimens (aminosalicylates, steroids, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Mild or No Activity)', 'description': 'Participants with diagnosis of mild ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1.'}], 'classes': [{'title': 'Gender, Male', 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}]}, {'title': 'Gender, Female', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Employed', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unemployed', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Student', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Retired', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Other', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Professional Status, Unknown', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Socio-demographic variables included gender and professional status.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Mild or No Activity)', 'description': 'Participants with diagnosis of mild ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1.'}], 'classes': [{'title': 'Family History of IBD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Never Smoked', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}]}, {'title': 'Smoking Status, Former Smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Smoking status, Current smoker', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Medical History, Comorbidity or EIM', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}]}]}, {'title': 'Extent Inflammation, E1-Distal: Proctitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Extent Inflammation, E1-Distal: Proctosigmoiditis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Inflammation, E2-Left-sided', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}]}, {'title': 'Extent of Inflammation, E3-Pancolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '56', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S0-Clinical Remission', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S1-Mild UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S2-Moderate UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Severity, S3-Severe UC', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-dependent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Steroid Behavior, Steroid-refractory disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Colonoscopy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Mild or No Activity)', 'description': 'Participants with diagnosis of mild ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1.'}], 'classes': [{'title': 'Type of Therapy, Salicylic Derivates', 'categories': [{'measurements': [{'value': '75.0', 'groupId': 'OG000'}, {'value': '68.2', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Corticosteroids', 'categories': [{'measurements': [{'value': '36.1', 'groupId': 'OG000'}, {'value': '12.1', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Immunosuppressors', 'categories': [{'measurements': [{'value': '47.2', 'groupId': 'OG000'}, {'value': '43.0', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Biologic Therapy', 'categories': [{'measurements': [{'value': '30.6', 'groupId': 'OG000'}, {'value': '28.0', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Antibiotics', 'categories': [{'measurements': [{'value': '13.9', 'groupId': 'OG000'}, {'value': '1.9', 'groupId': 'OG001'}]}]}, {'title': 'Type of Therapy, Other', 'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '7.9', 'groupId': 'OG001'}]}]}, {'title': 'Previous Surgery', 'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Treatment variables include previous treatments or regimens (aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '8.53', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.7', 'spread': '3.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Month 12', 'description': 'HBI scale assessed the severity of CD. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. Higher score indicates higher disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '197.3', 'spread': '124.44', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '122.0', 'spread': '68.82', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Month 12', 'description': 'CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Longitudinal population included all participants who were eligible for the prospective period. Participants with active CD with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '5.4', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '2.3', 'spread': '2.16', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1 and Month 12', 'description': "The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease).", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Longitudinal population included all participants who were eligible for the prospective period. Participants with active UC with data available for analysis at Day 1 and Month 12 were observed for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Adverse Reaction', 'categories': [{'measurements': [{'value': '7.1', 'groupId': 'OG000'}, {'value': '3.8', 'groupId': 'OG001'}]}]}, {'title': 'Comorbidity', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Contraindication', 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Pregnancy', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Surgery', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Weight change', 'categories': [{'measurements': [{'value': '0.4', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Poor Effectiveness', 'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '12.4', 'groupId': 'OG001'}]}]}, {'title': 'Remission', 'categories': [{'measurements': [{'value': '11.0', 'groupId': 'OG000'}, {'value': '27.5', 'groupId': 'OG001'}]}]}, {'title': 'Patient decision', 'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}, {'title': 'Patient poor adherence', 'categories': [{'measurements': [{'value': '3.2', 'groupId': 'OG000'}, {'value': '1.3', 'groupId': 'OG001'}]}]}, {'title': 'Patient access to the treatment', 'categories': [{'measurements': [{'value': '0.7', 'groupId': 'OG000'}, {'value': '0.0', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '25.1', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '38.9', 'groupId': 'OG000'}, {'value': '46.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 12', 'description': 'One participant could have more than one reason for discontinuation.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Longitudinal population included all participants who were eligible for the prospective period (participants with active IBD at Day 1).'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '68.9', 'spread': '22.14', 'groupId': 'OG000'}, {'value': '55.2', 'spread': '22.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Mental Component Score', 'categories': [{'measurements': [{'value': '42.6', 'spread': '12.00', 'groupId': 'OG000'}, {'value': '36.4', 'spread': '13.48', 'groupId': 'OG001'}]}]}, {'title': 'Physical Component Score', 'categories': [{'measurements': [{'value': '43.3', 'spread': '10.15', 'groupId': 'OG000'}, {'value': '40.8', 'spread': '9.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a participant's health related quality of life. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '158.9', 'spread': '41.41', 'groupId': 'OG000'}, {'value': '153.2', 'spread': '49.66', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The total score ranged from 32 to 224, with higher scores representing better quality of life. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '263', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Bowel Systems', 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.24', 'groupId': 'OG000'}, {'value': '5.1', 'spread': '1.63', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Health', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.46', 'groupId': 'OG000'}, {'value': '4.6', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Systemic Systems', 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '1.64', 'groupId': 'OG001'}]}]}, {'title': 'Social Function', 'categories': [{'measurements': [{'value': '5.2', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '5.0', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Percentage of Total Work Productivity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '32.3', 'spread': '32.97', 'groupId': 'OG000'}, {'value': '25.3', 'spread': '33.13', 'groupId': 'OG001'}]}]}, {'title': 'Percentage of Total Activity Impairment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '35.8', 'spread': '33.49', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '37.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "The Work Productivity and Activity Impairment questionnaire (WPAI) assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The 'impairment while working due to IBD' was calculated based on one question: to what degree did the disease impair the productivity while working in the past seven days from visit and the 'activity impairment' was calculated based on Question: how much did the disease affect ability to perform regular daily activities, other than work at a job? Percentage of overall work impairment due to IBD is calculated as: Absenteeism+(1-Absenteeism)\\*Presenteeism. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity).", 'unitOfMeasure': 'percentage of total work impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment). Number analyzed is the number of participants with evaluable data at the given time-point.'}, {'type': 'SECONDARY', 'title': 'Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'spread': '23.78', 'groupId': 'OG000'}, {'value': '11.7', 'spread': '26.69', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\\[(1-(Q2/(Q2+Q4))x(Q5/10)\\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.", 'unitOfMeasure': 'percentage of work time missed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.4', 'spread': '27.94', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '26.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Mean impairment while working due to IBD from WPAI questionnaire was reported. The 'impairment while working due to IBD' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. ata are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.", 'unitOfMeasure': 'percentage of impairment while working', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'OG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.8', 'spread': '33.49', 'groupId': 'OG000'}, {'value': '39.9', 'spread': '37.45', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 1', 'description': "Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\\[(1-(Q2/(Q2+Q4))x(Q5/10)\\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity.", 'unitOfMeasure': 'percentage of total activity impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Cross-sectional population included all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Who Used Healthcare Resources', 'denoms': [{'units': 'Participants', 'counts': [{'value': '118', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Moderate to Severe Activity)", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase."}, {'id': 'OG001', 'title': 'Ulcerative Colitis (Moderate to Severe Activity)', 'description': 'Participants with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'classes': [{'title': 'Previous Imaging and Laboratory Testing Due to IBD', 'categories': [{'measurements': [{'value': '98.3', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}, {'title': 'Previous Surgery for IBD', 'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'Previous Hospitalization Due to IBD', 'categories': [{'measurements': [{'value': '43.2', 'groupId': 'OG000'}, {'value': '30.6', 'groupId': 'OG001'}]}]}, {'title': 'Previous Medical Appointments Due to IBD', 'categories': [{'measurements': [{'value': '99.2', 'groupId': 'OG000'}, {'value': '100.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants with moderate to severe CD or UC from the cross-sectional population, including all participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'FG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}], 'periods': [{'title': 'Cross-sectional Phase (Day 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '264'}, {'groupId': 'FG001', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'comment': 'Participants with moderate to severe IBD at Day 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '146'}, {'groupId': 'FG001', 'numSubjects': '107'}]}], 'dropWithdraws': [{'type': 'Not Eligible for Prospective Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '144'}, {'groupId': 'FG001', 'numSubjects': '107'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Prospective Phase (Day 1 up to Month 12)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '118'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '107'}, {'groupId': 'FG001', 'numSubjects': '34'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal of Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Reason Not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants took part in the study at the 14 investigative sites in Brazil from 11 October 2016 to 19 Feb 2018.', 'preAssignmentDetails': "Participants diagnosed with infectious bowel disease (IBD)- Crohn's disease (CD) or ulcerative colitis (UC) were observed to collect the retrospective data on Day 1. Participants with active disease at Day 1 entered Prospective phase and were followed up for a period of 12 months."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': "Crohn's Disease", 'description': 'Participants with diagnosis of CD for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active CD at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'BG001', 'title': 'Ulcerative Colitis', 'description': 'Participants with diagnosis of UC for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active UC at Day 1 were followed up for 12 months in prospective phase.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '42.9', 'spread': '12.96', 'groupId': 'BG000'}, {'value': '45.9', 'spread': '13.83', 'groupId': 'BG001'}, {'value': '43.9', 'spread': '13.34', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '224', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '62', 'groupId': 'BG001'}, {'value': '183', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Brazil', 'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Professional Situation', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Employed', 'measurements': [{'value': '101', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}]}, {'title': 'Unemployed', 'measurements': [{'value': '61', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}, {'title': 'Student', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Retired', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by the following categories: employed, unemployed, student, retired, other, unknown.', 'unitOfMeasure': 'Participants'}, {'title': 'Educational Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Not Literate', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Primary School', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Primary School Not Completed', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Secondary School', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Secondary School Not Completed', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Higher Education', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Higher Education Not Completed', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Post-graduate/Master of Business Administration', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '57', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '102', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by the following categories: not literate, primary school, primary school not completed, secondary school, secondary school not completed, higher education, higher education not completed, post-graduate/master of business administration (MBA), unknown.', 'unitOfMeasure': 'Participants'}, {'title': 'Income', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'title': '>10-20 MS (R$ 8.800,01- R$ 17.600,00)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': '> 5-10 MS (R$ 4.400,01 - R$ 8.800,00)', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>3-5 MS (R$ 2.640,01 - R$ 4.440,00)', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': '>2-3 MS (R$ 1.760,01 - R$ 2.640,00)', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': '>1-2 MS (R$ 880,01 - R$ 1.760,00)', 'measurements': [{'value': '49', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '65', 'groupId': 'BG002'}]}, {'title': '>1/2-1 MS (R$ 440,01 - R$ 880,00)', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': '≤1/2 MS (Until R$ 440,00 (Including))', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'No Income', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}, {'title': 'Unknown/Not Informed', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '74', 'groupId': 'BG001'}, {'value': '179', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by their monthly salary (MS). The following categories were made: \\>10-20 MS (R$ 8.800,01- R$ 17.600,00), \\>5-10 MS (R$ 4.400,01 - R$ 8.800,00), \\>3-5 MS (R$ 2.640,01 - R$ 4.440,00), \\>2-3 MS (R$ 1.760,01 - R$ 2.640,00), \\>1-2 MS (R$ 880,01 - R$ 1.760,00), \\>1/2-1 MS (R$ 440,01 - R$ 880,00), ≤1/2 MS (Until R$ 440,00 (including)), no income, unknown/not informed.', 'unitOfMeasure': 'Participants'}, {'title': 'Height', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '250', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '386', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '166.0', 'spread': '9.89', 'groupId': 'BG000'}, {'value': '165.1', 'spread': '10.70', 'groupId': 'BG001'}, {'value': '165.7', 'spread': '10.18', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for height.'}, {'title': 'Weight', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '262', 'groupId': 'BG000'}, {'value': '141', 'groupId': 'BG001'}, {'value': '403', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '69.0', 'spread': '14.52', 'groupId': 'BG000'}, {'value': '70.1', 'spread': '14.33', 'groupId': 'BG001'}, {'value': '69.4', 'spread': '14.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with data available for weight.'}, {'title': '(Body Mass Index) BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '249', 'groupId': 'BG000'}, {'value': '136', 'groupId': 'BG001'}, {'value': '385', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '4.67', 'groupId': 'BG000'}, {'value': '25.7', 'spread': '4.63', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '4.66', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Body Mass Index=weight (kg)/\\[height (m)\\^2\\]', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Number analyzed is the number of participants with available for BMI.'}, {'title': 'Smoking Status', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '264', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '407', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Never Smoked', 'measurements': [{'value': '171', 'groupId': 'BG000'}, {'value': '91', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': 'Former Smoker', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'Current Smoker', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}]}, {'title': 'Unknown', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by the following categories: never smoked, former smoker (not smoking at Day 1 but smoked 100 cigarettes in his/her lifetime), current smoker (smoking at Day 1 and has smoked 100 cigarettes in his/her lifetime), unknown.', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All enrolled participants who had completed the Day 1 assessment (occurred 6 months after start of enrolment), included in Cross-sectional population.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-17', 'size': 1652598, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-10-01T15:40', 'hasProtocol': True}, {'date': '2018-01-30', 'size': 1270207, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-10-01T15:40', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-11', 'studyFirstSubmitDate': '2016-06-30', 'resultsFirstSubmitDate': '2019-10-01', 'studyFirstSubmitQcDate': '2016-06-30', 'lastUpdatePostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-02-11', 'studyFirstPostDateStruct': {'date': '2016-07-04', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Percentage of Participants With Active Crohn's Disease (CD) at Day 1", 'timeFrame': 'Day 1', 'description': 'Participants with Harvey Bradshaw Index (HBI) score of ≥8 or Crohn´s Disease Activity Index (CDAI) ≥220 points at Day 1 were classified as participants with active disease. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. The CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.'}, {'measure': 'Number of Participants With Active Ulcerative Colitis (UC) at Day 1', 'timeFrame': 'Day 1', 'description': "Participants with ≥5 points in Partial Mayo Score were classified as active UC disease. The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease)."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Moderate to Severe CD or UC Stratified by Age, Gender, Professional Status, Family History, Educational Level and Income at Day 1', 'timeFrame': 'Day 1'}, {'measure': 'Number of Participants With Moderate to Severe CD or UC Stratified by Clinical Variables', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; anthropometric (Height, Weight and BMI); Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g, Eligibility for 12-month follow-up.'}, {'measure': 'Percentage of Participants With Moderate to Severe CD or UC Who Used Various Types of Therapies for IBD in Previous 3 Years', 'timeFrame': 'Within the previous 3 years including Day 1', 'description': 'Therapies for IBD included aminosalicylates, steroids, immunossupressors, biologics, antibiotics, surgeries and others. One participant could use more than one therapy.'}, {'measure': 'Percentage of Participants With Moderate to Severe CD or UC Treated With Biologic Therapy Within 3 Previous Years', 'timeFrame': 'Within the previous 3 years including Day 1', 'description': 'IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab. One participant could use more than one biologic therapy.'}, {'measure': 'Percentage of Participants With Moderate to Severe CD or UC Who Have Not Responded Previously to Biologic Therapies', 'timeFrame': 'Day 1', 'description': 'IBD types included CD and UC. Biologic therapies included treatment with infliximab, adalimumab, vedolizumab, certolizumab, golimumab and ustekimumab.'}, {'measure': 'Percentage of Participants With Moderate to Severe CD or UC Who Were Ongoing IBD Treatment at Day 1', 'timeFrame': 'Day 1', 'description': 'Participants with moderate to severe CD or UC ongoing IBD treatment at Day 1 were reported.'}, {'measure': 'Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Socio-demographic Variables', 'timeFrame': 'Day 1', 'description': 'Socio-demographic variables included gender and professional status.'}, {'measure': 'Number of Participants With Moderate to Severe Activity of CD or With Light or no Activity Stratified by Clinical Variables', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Disease location -L1=ileal, L2=colonic disease, L3=ileocolic, L4=isolated upper GI tract disease location. Behavior as B1/B1+P=Non stenosing/non penetrating or B1+P=Non stenosing/non penetrating+perianal disease, B2/B2+P=Stenosing/B2+P=Stenosing+perianal disease B3/B3+P=Penetrating, B3+P=Penetrating+perianal disease, P=Penetrating disease. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g.'}, {'measure': 'Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of CD or With Light or no Activity Stratified by Treatment Variables', 'timeFrame': 'Day 1', 'description': 'Treatment variables included previous treatments or regimens (aminosalicylates, steroids, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.'}, {'measure': 'Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Socio-demographic Variables', 'timeFrame': 'Day 1', 'description': 'Socio-demographic variables included gender and professional status.'}, {'measure': 'Number of Participants With Moderate to Severe Activity of UC or With Light or no Activity Stratified by Clinical Variables', 'timeFrame': 'Day 1', 'description': 'Clinical variables included IBD type:CD/UC; Family history; Smoking habits; Medical History/Comorbidities; Extension of inflammation as E1=distal UC: proctitis or E1=distal UC: proctosigmoiditis extension of inflammation E2/E3=left-sided: mucosa inflammation extending up to splenic flexure or E3=pancolitis: mucosa inflammation up to proximal transverse colon and beyond extension of inflammation and severity of UC as S0=Clinical remission, S1=Mild UC, S2=Moderate UC, S3=Severe UC. Steroid behavior; Colonoscopy, Calprotectin levels \\>200ug/g.'}, {'measure': 'Percentage of Participants With Treatment Beginning or Ongoing at Day 1 by Moderate to Severe Activity of UC or With Light or no Activity Stratified by Treatment Variables', 'timeFrame': 'Day 1', 'description': 'Treatment variables include previous treatments or regimens (aminosalicylates, steroids, immunomodulators, immunossupressors, biologics, antibiotics); and previous surgeries for IBD. One participant could use more than one treatment regimens.'}, {'measure': 'Harvey Bradshaw Index (HBI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12', 'timeFrame': 'Day 1 and Month 12', 'description': 'HBI scale assessed the severity of CD. HBI scale assessed five dimensions (general well-being, abdominal pain, number of liquid stools per day, abdominal mass, and complications). These dimensions were scored from the previous day. The total score ranges from 0 to 25. Higher score indicates higher disease activity.'}, {'measure': 'Crohn´s Disease Activity Index (CDAI) Total Score in Participants Who Had Moderate to Severe Active CD at Day 1 and Month 12', 'timeFrame': 'Day 1 and Month 12', 'description': 'CDAI evaluated the severity of signs and symptoms of CD. Collected data included information on the number of liquid stools, intensity of abdominal pain, general well-being, presence of comorbid conditions, use of medications for diarrhea, physical examination, and laboratory findings (abdominal mass, hematocrit, body weight), yielding 8 items that were combined with data from a 7-day diary to obtain the total CDAI score which ranges from 0 to approximately 600 points, where higher score indicates higher disease activity.'}, {'measure': 'Partial Mayo Score in Participants Who Had Moderate to Severe Active UC at Day 1 and Month 12', 'timeFrame': 'Day 1 and Month 12', 'description': "The mayo score without endoscopy measured severity of ulcerative colitis. Three sub-scores for stool frequency, rectal bleeding, and physician's global assessment were each graded from 0 to 3 with higher scores indicating more severe disease. Individual sub-scores were then summed to provide the total score ranging from 0 (normal or inactive disease) to 9 (severe disease)."}, {'measure': 'Percentage of Participants With Moderate to Severe Active CD or UC Who Changed IBD Treatment at Month 12, by Reason', 'timeFrame': 'Month 12', 'description': 'One participant could have more than one reason for discontinuation.'}, {'measure': 'Quality of Life as Assessed by European Quality of Life 5-Dimension (EQ-5D) Health States Visual Analog Scale (VAS) Score at Day 1', 'timeFrame': 'Day 1', 'description': 'EQ-5D questionnaire is an instrument used to measure general HRQOL in participants with IBD. Each dimension has three possible levels: 1 = none, 2 = moderate or 3 = extreme. The EQ-5D VAS score is a self-assigned rating of overall health using a 20-cm visual, vertical scale, with a score of 0 as the worst and 100 as the best possible health. An increase of ≥7 points in the EQ-5D VAS score represents a clinically meaningful improvement in quality of life for participants.'}, {'measure': 'Quality of Life as Assessed by 36-Item Short Form Health Survey (SF-36) Component Score at Day 1', 'timeFrame': 'Day 1', 'description': "The Short Form-36 (SF-36) is a questionnaire that evaluates a participant's health related quality of life. SF-36 includes 36 questions related to 8 health dimensions: physical functioning, role-physical (role limitations due to physical health problems), bodily pain, general health, vitality (energy/fatigue), social functioning, role-emotional (role limitations due to emotional problems), and mental health. Based on these 4 scales (physical functioning, role-physical, bodily pain, general health), the physical component summary (PCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life. Based on these 4 scales (vitality, social functioning, role-emotional, and mental health), the mental component summary (MCS) score is generated which ranges between 0 and 100, with higher scores indicating a better quality of life."}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Day 1', 'timeFrame': 'Day 1', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the sum of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best. The total score ranged from 32 to 224, with higher scores representing better quality of life. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.'}, {'measure': 'Inflammatory Bowel Disease Questionnaire (IBDQ) Domain Score at Day 1', 'timeFrame': 'Day 1', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) was a 32-item questionnaire that measures 4 dimensions: bowel function, emotional status, systemic symptoms, and social function. Within dimensions, each question presented seven possible answers/points. Each domain score was the average of 8 responses each ranging from 1 to 7, where 1 indicated worst function and 7 the best function. The IBDQ was not validated for participants with colostomies and therefore was not be applied for these participants.'}, {'measure': 'Mean of Percentage of Total Work Impairment Due to CD as Assessed by Work Productivity and Activity Impairment (WPAI) Questionnaire at Day 1', 'timeFrame': 'Day 1', 'description': "The Work Productivity and Activity Impairment questionnaire (WPAI) assessed the impact of IBD on work productivity and daily activities during the previous 7 days. The 'impairment while working due to IBD' was calculated based on one question: to what degree did the disease impair the productivity while working in the past seven days from visit and the 'activity impairment' was calculated based on Question: how much did the disease affect ability to perform regular daily activities, other than work at a job? Percentage of overall work impairment due to IBD is calculated as: Absenteeism+(1-Absenteeism)\\*Presenteeism. The total score ranges from 0 (no impairment) to 100% (total loss of work productivity)."}, {'measure': 'Mean of Percentage of Work Time Missed Due to CD as Assessed by WPAI at Day 1', 'timeFrame': 'Day 1', 'description': "Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\\[(1-(Q2/(Q2+Q4))x(Q5/10)\\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity."}, {'measure': 'Mean of Percentage of Impairment While Working Due to CD as Assessed by WPAI at Day 1', 'timeFrame': 'Day 1', 'description': "Mean impairment while working due to IBD from WPAI questionnaire was reported. The 'impairment while working due to IBD' was calculated based on one item: (Q5) to what degree did the disease impair the productivity while working in the past seven days. The item was measured on a scale from 0 (no effect) to 10 (completely prevented from doing regular activities/ working). The data was calculated using the formula Q5/10 and converted to percent. ata are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity."}, {'measure': 'Mean of Percentage of Total Activity Impairment Due to CD as Assessed by WPAI', 'timeFrame': 'Day 1', 'description': "Mean total activity impairment due to IBD from WPAI questionnaire was reported. The 'overall work impairment due to IBD' was calculated based on three items: (Q2) the number of hours missed from work due to health problems in the past seven days; (Q4) the number of actual work hours in the past seven days; and (Q5) to what degree did the disease impair the productivity while working past seven days. The data was calculated using the formula Q2/(Q2+Q4)+\\[(1-(Q2/(Q2+Q4))x(Q5/10)\\] and converted to percent. Data are presented as impairment percentage, with higher numbers indicating greater impairment and less productivity."}, {'measure': 'Percentage of Participants Who Used Healthcare Resources', 'timeFrame': 'Day 1', 'description': 'Healthcare resources used in the previous 3 years included imaging and laboratory testing, surgeries, hospitalizations, and consultations.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Drug Therapy'], 'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of available biologic therapies.', 'detailedDescription': 'This is a non-interventional study to determine the rate of control of disease activity in moderate to severe inflammatory bowel disease (IBD) participants, with two parts: cross-sectional evaluation (Day 1) with retrospective data collection and a prospective 12-month evaluation for patients with active IBD at cross-sectional evaluation (Day 1).\n\nThe study enrolled 407 patients. This multicenter trial was conducted in Brazil. Retrospective data of previous IBD treatments (drug, dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years will be collected. Prospective data was collected for a period of 12 months in participants with active disease. UC participants, with no or light disease activity at Day 1 did not continue to 12-month follow up. CD participants, with no or light disease activity at Day 1 but with colonoscopy or calprotectin levels (i.e, calprotectin \\>200 ug/g) in the previous year suggestive of inadequate control of activity progressed to 12-month follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult participants diagnosed with moderate to severe Crohn's Disease (CD) or Ulcerative Colitis (UC) were observed.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Male or female.\n2. 18 years or older (at the time of diagnosis of moderate to severe UC or CD).\n3. Diagnosis of moderate to severe CD or UC for at least 6 months prior to Day 1 appointment according the clinical or endoscopic \\\\ criteria.\n4. Has provided the written informed consent. For the prospective period, eligible participants should present at least one of the following criteria that will only be applied at Day 1:\n5. For CD participants:\n\n * Harvey Bradshaw Index (HBI) ≥8 or\n * Crohn's Disease Activity Index (CDAI) ≥220 or Considering that for CD participants, the disease activity may not be clearly documented only with clinical data, some objective criteria may be considered as entry criteria for the 12-month prospective period:\n * Colonoscopy in the previous year suggestive of inadequate control of activity or,\n * Calprotectin levels in the previous year suggestive of inadequate control of activity (i.e, calprotectin \\>200 µg/g).\n6. For UC: partial Mayo Score ≥5.\n\nNote: Participants with colostomy and prospective period: Although clinical scales defined above are impacted by colostomy these participants will not be excluded from the protocol to ensure the assessment of different clinical presentations of the IBD. In addition, participants with colostomy must follow the same criteria as above to be eligible to the prospective phase.\n\nExclusion Criteria:\n\n1. Indeterminate or not classified colitis.\n2. Current or previous participation in interventional clinical trial (within the last 3 years). In addition, for the 12-month prospective period, participants will be excluded if:\n3. Presenting mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation.\n4. Hospitalized participants at Day 1.\n5. Current off label treatment with Vedolizumab.\n\nStudy Discontinuation Criteria It will be considered a premature termination the situation in which the participant discontinues the participation, i.e. they are withdrawn from the study before completing the 12 months of follow up period (365 days ± 14 days from Day 1), due to any of the reasons listed below:\n\n1. Withdrawal of consent: participants who for any reason withdraw the free and informed consent;\n2. Lost to follow-up (no return of the participant on the expected date of visit - drop-out from the protocol);\n3. Death;\n4. Study termination;\n5. Any situation that places the participant within one of the exclusion criteria.\n\nNote: Participants who are eligible for the prospective period, it means, with active disease at Day 1 but who during the 12 months period presents disease remission and/or no activity disease condition, are allowed to continue the participation in the study."}, 'identificationModule': {'nctId': 'NCT02822235', 'briefTitle': 'Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil', 'organization': {'class': 'INDUSTRY', 'fullName': 'Takeda'}, 'officialTitle': 'Real-world Data of Moderate to Severe Inflammatory Bowel Disease in Brazil: a Non-interventional, Multicenter Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life (RISE BR)', 'orgStudyIdInfo': {'id': 'Vedolizumab-4008'}, 'secondaryIdInfos': [{'id': 'U1111-1178-66445', 'type': 'REGISTRY', 'domain': 'WHO'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's Disease", 'description': "Participants with diagnosis of moderate to severe Crohn's disease (CD) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and CD at Day 1 were followed up for 12 months in prospective phase.", 'interventionNames': ['Other: No Intervention']}, {'label': 'Ulcerative Colitis', 'description': 'Participants diagnosed with diagnosis of moderate to severe ulcerative colitis (UC) for at least 6 months prior to Day 1 were observed to collect the retrospective data including previous inflammatory bowel disease (IBD) treatments (drug dose, treatment duration, drug changes), and use of other health resources related with the management of IBD for previous three years at Day 1. Participants with active IBD and UC at Day 1 were followed up for 12 months in prospective phase.', 'interventionNames': ['Other: No Intervention']}], 'interventions': [{'name': 'No Intervention', 'type': 'OTHER', 'armGroupLabels': ["Crohn's Disease", 'Ulcerative Colitis']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Salvador', 'state': 'Estado de Bahia', 'country': 'Brazil', 'geoPoint': {'lat': -12.97563, 'lon': -38.49096}}, {'city': 'Goiânia', 'state': 'Goiás', 'country': 'Brazil', 'geoPoint': {'lat': -16.67861, 'lon': -49.25389}}, {'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'city': 'Juiz de Fora', 'state': 'Minas Gerais', 'country': 'Brazil', 'geoPoint': {'lat': -21.76417, 'lon': -43.35028}}, {'city': 'Curitiba', 'state': 'Paraná', 'country': 'Brazil', 'geoPoint': {'lat': -25.42778, 'lon': -49.27306}}, {'city': 'Teresina', 'state': 'Piauí', 'country': 'Brazil', 'geoPoint': {'lat': -5.08917, 'lon': -42.80194}}, {'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'city': 'Botucatu', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -22.88583, 'lon': -48.445}}, {'city': 'Ribeirão Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -21.1775, 'lon': -47.81028}}, {'city': 'Santo André', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.66389, 'lon': -46.53833}}, {'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}, {'city': 'Rio de Janeiro', 'country': 'Brazil', 'geoPoint': {'lat': -22.90642, 'lon': -43.18223}}, {'city': 'São Paulo', 'country': 'Brazil', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Abner Augusto Lobão Neto Clinical Science', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Takeda'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Takeda', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}