Ignite Creation Date:
2025-12-24 @ 1:01 PM
Ignite Modification Date:
2026-03-02 @ 9:43 AM
Study NCT ID:
NCT02914561
Status:
COMPLETED
Last Update Posted:
2023-12-18
First Post:
2016-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Mexico']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C584571', 'term': 'GLPG0634'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'medicalinfo@glpg.com', 'phone': '+32 15 342900', 'title': 'Galapagos Medical Information', 'organization': 'Galapagos NV'}, 'certainAgreement': {'otherDetails': 'The sponsor must review and approve any results of the study or abstracts for professional meetings prepared by the investigator(s). Published data must not compromise the objectives of the study. Data from individual study centers in multicenter studies must not be published separately.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose up to Week 62', 'description': 'Safety Analysis Set', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'otherNumAtRisk': 222, 'deathsNumAtRisk': 222, 'otherNumAffected': 87, 'seriousNumAtRisk': 222, 'deathsNumAffected': 0, 'seriousNumAffected': 18}, {'id': 'EG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.', 'otherNumAtRisk': 245, 'deathsNumAtRisk': 245, 'otherNumAffected': 90, 'seriousNumAtRisk': 245, 'deathsNumAffected': 0, 'seriousNumAffected': 16}, {'id': 'EG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks..', 'otherNumAtRisk': 237, 'deathsNumAtRisk': 237, 'otherNumAffected': 90, 'seriousNumAtRisk': 237, 'deathsNumAffected': 0, 'seriousNumAffected': 15}, {'id': 'EG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks', 'otherNumAtRisk': 202, 'deathsNumAtRisk': 202, 'otherNumAffected': 106, 'seriousNumAtRisk': 202, 'deathsNumAffected': 0, 'seriousNumAffected': 19}, {'id': 'EG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.', 'otherNumAtRisk': 228, 'deathsNumAtRisk': 228, 'otherNumAffected': 107, 'seriousNumAtRisk': 228, 'deathsNumAffected': 0, 'seriousNumAffected': 36}, {'id': 'EG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'otherNumAtRisk': 229, 'deathsNumAtRisk': 229, 'otherNumAffected': 109, 'seriousNumAtRisk': 229, 'deathsNumAffected': 0, 'seriousNumAffected': 26}, {'id': 'EG006', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.', 'otherNumAtRisk': 118, 'deathsNumAtRisk': 118, 'otherNumAffected': 59, 'seriousNumAtRisk': 118, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG007', 'title': 'Filgotinib 200 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.', 'otherNumAtRisk': 56, 'deathsNumAtRisk': 56, 'otherNumAffected': 28, 'seriousNumAtRisk': 56, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG008', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.', 'otherNumAtRisk': 104, 'deathsNumAtRisk': 104, 'otherNumAffected': 59, 'seriousNumAtRisk': 104, 'deathsNumAffected': 0, 'seriousNumAffected': 14}, {'id': 'EG009', 'title': 'Filgotinib 100 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.', 'otherNumAtRisk': 55, 'deathsNumAtRisk': 55, 'otherNumAffected': 25, 'seriousNumAtRisk': 55, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG010', 'title': 'Placebo to Placebo (Maintenance Study)', 'description': 'Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.', 'otherNumAtRisk': 145, 'deathsNumAtRisk': 145, 'otherNumAffected': 77, 'seriousNumAtRisk': 145, 'deathsNumAffected': 0, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 6, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 104, 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'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Drug-induced liver injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Ovarian cyst', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}, {'term': 'Gastrointestinal fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 222, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 245, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 237, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 202, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 228, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 229, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 118, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 56, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 104, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 55, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 145, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.0)'}], 'frequencyThreshold': '2.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '228', 'groupId': 'OG004'}, {'value': '229', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '39.3'}, {'value': '25.7', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '31.4'}, {'value': '19.8', 'groupId': 'OG002', 'lowerLimit': '14.5', 'upperLimit': '25.1'}, {'value': '26.7', 'groupId': 'OG003', 'lowerLimit': '20.4', 'upperLimit': '33.1'}, {'value': '16.7', 'groupId': 'OG004', 'lowerLimit': '11.6', 'upperLimit': '21.7'}, {'value': '14.8', 'groupId': 'OG005', 'lowerLimit': '10.0', 'upperLimit': '19.7'}]}]}], 'analyses': [{'pValue': '0.0017', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '4.7', 'ciUpperLimit': '20.7', 'groupDescription': 'Cochran-Mantel-Haenszel (CMH) test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.1730', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.2', 'ciLowerLimit': '-2.4', 'ciUpperLimit': '12.7', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0023', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '4.1', 'ciUpperLimit': '19.9', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6038', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.8', 'ciLowerLimit': '-5.2', 'ciUpperLimit': '8.7', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical remission was defined as a CDAI of \\< 150 points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Full Analysis Set (FAS) for each Induction Study (Cohorts A and B) included all randomized participants who took at least 1 dose of study drug in the corresponding Induction Study.'}, {'type': 'PRIMARY', 'title': 'Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '228', 'groupId': 'OG004'}, {'value': '229', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.9', 'groupId': 'OG000', 'lowerLimit': '18.0', 'upperLimit': '29.7'}, {'value': '20.8', 'groupId': 'OG001', 'lowerLimit': '15.5', 'upperLimit': '26.1'}, {'value': '18.1', 'groupId': 'OG002', 'lowerLimit': '13.0', 'upperLimit': '23.3'}, {'value': '11.9', 'groupId': 'OG003', 'lowerLimit': '7.2', 'upperLimit': '16.6'}, {'value': '13.6', 'groupId': 'OG004', 'lowerLimit': '8.9', 'upperLimit': '18.3'}, {'value': '11.4', 'groupId': 'OG005', 'lowerLimit': '7.0', 'upperLimit': '15.7'}]}]}], 'analyses': [{'pValue': '0.1365', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '12.9', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (0, \\>=1) at Day 1.'}, {'pValue': '0.5103', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-4.8', 'ciUpperLimit': '9.5', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9797', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.1', 'ciLowerLimit': '-6.5', 'ciUpperLimit': '6.6', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'CMH test stratified by use of corticosteroids (Yes/No), immunomodulators (Yes/No), and prior exposure to biologic agents (\\<=1, \\>1) at Day 1.'}, {'pValue': '0.4264', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.4', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '8.8', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': "The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for induction study was analyzed.'}, {'type': 'PRIMARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '33.2', 'upperLimit': '52.5'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '14.6', 'upperLimit': '32.4'}, {'value': '28.3', 'groupId': 'OG002', 'lowerLimit': '15.2', 'upperLimit': '41.4'}, {'value': '22.6', 'groupId': 'OG003', 'lowerLimit': '10.4', 'upperLimit': '34.9'}]}]}], 'analyses': [{'pValue': '0.0839', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.7', 'ciLowerLimit': '-1.0', 'ciUpperLimit': '28.4', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.8288', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.5', 'ciLowerLimit': '-12.1', 'ciUpperLimit': '15.0', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical remission was defined as a CDAI of \\< 150 points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study included all participants randomized to either the filgotinib 200 mg or filgotinib 100 mg treatment groups in the Induction Studies who were re-randomized in the Maintenance Study and took at least 1 dose of study drug in the Maintenance Study and achieved clinical remission by PRO2 or endoscopic response at Week 10.'}, {'type': 'PRIMARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.4', 'groupId': 'OG000', 'lowerLimit': '21.4', 'upperLimit': '39.3'}, {'value': '18.4', 'groupId': 'OG001', 'lowerLimit': '10.2', 'upperLimit': '26.5'}, {'value': '9.4', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '18.2'}, {'value': '13.2', 'groupId': 'OG003', 'lowerLimit': '3.1', 'upperLimit': '23.3'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.6', 'ciLowerLimit': '8.2', 'ciUpperLimit': '33.1', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3466', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-6.6', 'ciUpperLimit': '18.3', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': 'The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '228', 'groupId': 'OG004'}, {'value': '229', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.9', 'groupId': 'OG000', 'lowerLimit': '26.5', 'upperLimit': '39.3'}, {'value': '30.6', 'groupId': 'OG001', 'lowerLimit': '24.6', 'upperLimit': '36.6'}, {'value': '25.7', 'groupId': 'OG002', 'lowerLimit': '20.0', 'upperLimit': '31.5'}, {'value': '29.7', 'groupId': 'OG003', 'lowerLimit': '23.2', 'upperLimit': '36.3'}, {'value': '18.9', 'groupId': 'OG004', 'lowerLimit': '13.6', 'upperLimit': '24.2'}, {'value': '17.9', 'groupId': 'OG005', 'lowerLimit': '12.7', 'upperLimit': '23.1'}]}]}], 'analyses': [{'pValue': '0.0963', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.9', 'ciLowerLimit': '-1.4', 'ciUpperLimit': '15.2', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.3050', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.2', 'ciLowerLimit': '-3.9', 'ciUpperLimit': '12.2', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, \\>=1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0039', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.9', 'ciLowerLimit': '3.7', 'ciUpperLimit': '20.2', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7556', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.1', 'ciLowerLimit': '-6.2', 'ciUpperLimit': '8.5', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for induction study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '245', 'groupId': 'OG001'}, {'value': '237', 'groupId': 'OG002'}, {'value': '202', 'groupId': 'OG003'}, {'value': '228', 'groupId': 'OG004'}, {'value': '229', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'groupId': 'OG000', 'lowerLimit': '45.5', 'upperLimit': '59.0'}, {'value': '46.1', 'groupId': 'OG001', 'lowerLimit': '39.7', 'upperLimit': '52.6'}, {'value': '39.7', 'groupId': 'OG002', 'lowerLimit': '33.2', 'upperLimit': '46.1'}, {'value': '38.6', 'groupId': 'OG003', 'lowerLimit': '31.7', 'upperLimit': '45.6'}, {'value': '35.5', 'groupId': 'OG004', 'lowerLimit': '29.1', 'upperLimit': '42.0'}, {'value': '27.5', 'groupId': 'OG005', 'lowerLimit': '21.5', 'upperLimit': '33.5'}]}]}], 'analyses': [{'pValue': '0.0074', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '3.2', 'ciUpperLimit': '20.8', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.2159', 'groupIds': ['OG001', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.5', 'ciLowerLimit': '-3.2', 'ciUpperLimit': '14.1', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (0, ≥1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0110', 'groupIds': ['OG003', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.6', 'ciLowerLimit': '2.6', 'ciUpperLimit': '20.6', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.0593', 'groupIds': ['OG004', 'OG005'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-0.4', 'ciUpperLimit': '16.7', 'groupDescription': 'CMH test was stratified by concomitant use of oral, systemic corticosteroids (Yes/No) and of immunomodulators (Yes/No) at Day 1, and number of prior exposures to biologic agent (\\<=1, \\>1).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \\< 150 points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS for induction study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.8', 'groupId': 'OG000', 'lowerLimit': '34.1', 'upperLimit': '53.4'}, {'value': '29.6', 'groupId': 'OG001', 'lowerLimit': '20.0', 'upperLimit': '39.1'}, {'value': '26.4', 'groupId': 'OG002', 'lowerLimit': '13.6', 'upperLimit': '39.2'}, {'value': '24.5', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '37.1'}]}]}], 'analyses': [{'pValue': '0.0382', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.8', 'ciLowerLimit': '2.0', 'ciUpperLimit': '31.6', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4263', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.8', 'ciLowerLimit': '-8.5', 'ciUpperLimit': '20.0', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '45.5', 'groupId': 'OG000', 'lowerLimit': '35.9', 'upperLimit': '55.2'}, {'value': '33.7', 'groupId': 'OG001', 'lowerLimit': '23.8', 'upperLimit': '43.5'}, {'value': '34.0', 'groupId': 'OG002', 'lowerLimit': '20.3', 'upperLimit': '47.7'}, {'value': '30.2', 'groupId': 'OG003', 'lowerLimit': '16.9', 'upperLimit': '43.5'}]}]}], 'analyses': [{'pValue': '0.1827', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '10.9', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '26.4', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.5944', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '4.0', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '19.2', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \\< 150 points.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'groupId': 'OG000', 'lowerLimit': '28.9', 'upperLimit': '47.8'}, {'value': '19.4', 'groupId': 'OG001', 'lowerLimit': '11.1', 'upperLimit': '27.7'}, {'value': '22.6', 'groupId': 'OG002', 'lowerLimit': '10.4', 'upperLimit': '34.9'}, {'value': '20.8', 'groupId': 'OG003', 'lowerLimit': '8.9', 'upperLimit': '32.6'}]}]}], 'analyses': [{'pValue': '0.0512', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.2', 'ciLowerLimit': '1.0', 'ciUpperLimit': '29.3', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.9801', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.2', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '13.0', 'groupDescription': 'CMH test was stratified by concomitant use of immunomodulators (Yes/No) at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 10 and 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nSustained Clinical Remission by CDAI: CDAI \\<150 combined at both Week 10 and Week 58.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '34.0', 'groupId': 'OG000', 'lowerLimit': '19.9', 'upperLimit': '48.1'}, {'value': '4.9', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '12.7'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '37.7'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '26.7'}]}]}], 'analyses': [{'pValue': '0.1900', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '14.0', 'ciLowerLimit': '-5.1', 'ciUpperLimit': '33.1', 'groupDescription': 'CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.4248', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.5', 'ciLowerLimit': '-22.6', 'ciUpperLimit': '11.6', 'groupDescription': 'CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': "The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\n6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \\<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.", 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '112', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '53', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '41.1', 'groupId': 'OG000', 'lowerLimit': '31.5', 'upperLimit': '50.6'}, {'value': '25.5', 'groupId': 'OG001', 'lowerLimit': '16.4', 'upperLimit': '34.7'}, {'value': '20.8', 'groupId': 'OG002', 'lowerLimit': '8.9', 'upperLimit': '32.6'}, {'value': '24.5', 'groupId': 'OG003', 'lowerLimit': '12.0', 'upperLimit': '37.1'}]}]}], 'analyses': [{'pValue': '0.0122', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.9', 'ciLowerLimit': '5.7', 'ciUpperLimit': '34.0', 'groupDescription': 'CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.7708', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.0', 'ciLowerLimit': '-12.0', 'ciUpperLimit': '16.1', 'groupDescription': 'CMH test was stratified by concomitant use immunomodulators (Yes/No), at Maintenance baseline, and history of exposure to a biologic agent (Yes/No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 10 and 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.\n\nSustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}, {'value': '25', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg - Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg - Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG002', 'title': 'Filgotinib 200 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG003', 'title': 'Filgotinib 100 mg - Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '32.0', 'groupId': 'OG000', 'lowerLimit': '18.1', 'upperLimit': '45.9'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '0.0', 'upperLimit': '16.5'}, {'value': '20.0', 'groupId': 'OG002', 'lowerLimit': '2.3', 'upperLimit': '37.7'}, {'value': '12.0', 'groupId': 'OG003', 'lowerLimit': '0.0', 'upperLimit': '26.7'}]}]}], 'analyses': [{'pValue': '0.2631', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.0', 'ciLowerLimit': '-8.3', 'ciUpperLimit': '32.3', 'groupDescription': 'CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.6444', 'groupIds': ['OG001', 'OG003'], 'paramType': 'Stratified Percentage Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-20.9', 'ciUpperLimit': '14.0', 'groupDescription': 'CMH test was stratified by immunomodulators (Yes) at Maintenance baseline, immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (Yes), and immunomodulators (No) at Maintenance baseline and history of exposure to biologic agent (No).', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.\n\n6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The FAS for the Maintenance Study with available data was analyzed.'}, {'type': 'SECONDARY', 'title': 'Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1170', 'spread': '1270', 'groupId': 'OG000'}, {'value': '611', 'spread': '634', 'groupId': 'OG001'}, {'value': '1140', 'spread': '1070', 'groupId': 'OG002'}, {'value': '604', 'spread': '634', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose', 'description': 'Plasma concentrations of filgotinib \\[nanogram/milliliters (ng/mL)\\].', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Pharmacokinetic (PK) Analysis Set (included all randomized participants who took at least 1 dose of filgotinib and had at least 1 non-missing concentration value for filgotinib and/or its metabolite GS-829845 reported by the PK laboratory) for Induction study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.8', 'spread': '180', 'groupId': 'OG000'}, {'value': '21.3', 'spread': '79.5', 'groupId': 'OG001'}, {'value': '47.9', 'spread': '215', 'groupId': 'OG002'}, {'value': '40.8', 'spread': '139', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10: Predose', 'description': 'Plasma concentrations of filgotinib (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Induction study was analyzed.'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26', 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '284', 'spread': '623', 'groupId': 'OG000'}, {'value': '58.5', 'spread': '150', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26: At any timepoint', 'description': 'Plasma concentrations of filgotinib (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Maintenance study was analyzed'}, {'type': 'SECONDARY', 'title': 'Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '75.8', 'spread': '238', 'groupId': 'OG000'}, {'value': '16.9', 'spread': '55.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 58: Pre-dose', 'description': 'Plasma concentrations of filgotinib (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Maintenance study was analyzed'}, {'type': 'SECONDARY', 'title': "Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4", 'denoms': [{'units': 'Participants', 'counts': [{'value': '177', 'groupId': 'OG000'}, {'value': '181', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '3100', 'spread': '1530', 'groupId': 'OG000'}, {'value': '1800', 'spread': '936', 'groupId': 'OG001'}, {'value': '3140', 'spread': '1450', 'groupId': 'OG002'}, {'value': '1870', 'spread': '776', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 4: 0.5, 1, 2, and 3 hrs post dose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Induction study was analyzed.'}, {'type': 'SECONDARY', 'title': "Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10", 'denoms': [{'units': 'Participants', 'counts': [{'value': '183', 'groupId': 'OG000'}, {'value': '180', 'groupId': 'OG001'}, {'value': '136', 'groupId': 'OG002'}, {'value': '135', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG002', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'OG003', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2550', 'spread': '1390', 'groupId': 'OG000'}, {'value': '1290', 'spread': '801', 'groupId': 'OG001'}, {'value': '2640', 'spread': '1470', 'groupId': 'OG002'}, {'value': '1480', 'spread': '917', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 10: Predose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Induction study was analyzed.'}, {'type': 'SECONDARY', 'title': "Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26", 'denoms': [{'units': 'Participants', 'counts': [{'value': '77', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '3090', 'spread': '1500', 'groupId': 'OG000'}, {'value': '1460', 'spread': '814', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 26: At any timepoint', 'description': 'Plasma concentrations of GS-829845 (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Maintenance study was analyzed'}, {'type': 'SECONDARY', 'title': "Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58", 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'OG001', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}], 'classes': [{'categories': [{'measurements': [{'value': '2430', 'spread': '1430', 'groupId': 'OG000'}, {'value': '1220', 'spread': '551', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 58: Pre-dose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'PK Analysis Set for Maintenance study was analyzed'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'FG006', 'title': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'FG007', 'title': 'Filgotinib 200 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'FG008', 'title': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}, {'id': 'FG009', 'title': 'Filgotinib 100 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.'}, {'id': 'FG010', 'title': 'Placebo to Placebo (Maintenance Study)', 'description': 'Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.'}], 'periods': [{'title': 'Induction Study (Day 1 to Week 10)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '223'}, {'groupId': 'FG001', 'numSubjects': '245'}, {'groupId': 'FG002', 'numSubjects': '239'}, {'groupId': 'FG003', 'numSubjects': '204'}, {'groupId': 'FG004', 'numSubjects': '230'}, {'groupId': 'FG005', 'numSubjects': '231'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '222'}, {'groupId': 'FG001', 'numSubjects': '245'}, {'groupId': 'FG002', 'numSubjects': '237'}, {'groupId': 'FG003', 'numSubjects': '202'}, {'groupId': 'FG004', 'numSubjects': '228'}, {'groupId': 'FG005', 'numSubjects': '229'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '204'}, {'groupId': 'FG001', 'numSubjects': '213'}, {'groupId': 'FG002', 'numSubjects': '212'}, {'groupId': 'FG003', 'numSubjects': '177'}, {'groupId': 'FG004', 'numSubjects': '183'}, {'groupId': 'FG005', 'numSubjects': '192'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '27'}, {'groupId': 'FG003', 'numSubjects': '27'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '39'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '14'}, {'groupId': 'FG002', 'numSubjects': '14'}, {'groupId': 'FG003', 'numSubjects': '24'}, {'groupId': 'FG004', 'numSubjects': '31'}, {'groupId': 'FG005', 'numSubjects': '19'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '12'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}]}, {'title': 'Maintenance Study (Weeks 11 to 58)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'comment': 'Not all participants who completed the induction study entered the maintenance study.', 'groupId': 'FG006', 'numSubjects': '118'}, {'comment': 'Not all participants who completed the induction study entered the maintenance study.', 'groupId': 'FG007', 'numSubjects': '56'}, {'comment': 'Not all participants who completed the induction study entered the maintenance study.', 'groupId': 'FG008', 'numSubjects': '105'}, {'comment': 'Not all participants who completed the induction study entered the maintenance study.', 'groupId': 'FG009', 'numSubjects': '56'}, {'comment': 'Not all participants who completed the induction study entered the maintenance study.', 'groupId': 'FG010', 'numSubjects': '146'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '118'}, {'groupId': 'FG007', 'numSubjects': '56'}, {'groupId': 'FG008', 'numSubjects': '104'}, {'groupId': 'FG009', 'numSubjects': '55'}, {'groupId': 'FG010', 'numSubjects': '145'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '64'}, {'groupId': 'FG007', 'numSubjects': '21'}, {'groupId': 'FG008', 'numSubjects': '45'}, {'groupId': 'FG009', 'numSubjects': '26'}, {'groupId': 'FG010', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '54'}, {'groupId': 'FG007', 'numSubjects': '35'}, {'groupId': 'FG008', 'numSubjects': '60'}, {'groupId': 'FG009', 'numSubjects': '30'}, {'groupId': 'FG010', 'numSubjects': '72'}]}], 'dropWithdraws': [{'type': 'Protocol-Specified Disease Worsening', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '31'}, {'groupId': 'FG007', 'numSubjects': '32'}, {'groupId': 'FG008', 'numSubjects': '40'}, {'groupId': 'FG009', 'numSubjects': '25'}, {'groupId': 'FG010', 'numSubjects': '43'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '9'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '11'}, {'groupId': 'FG009', 'numSubjects': '2'}, {'groupId': 'FG010', 'numSubjects': '12'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '5'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '9'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '4'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Non-Compliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}]}, {'type': 'Randomized but not treated', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '1'}]}]}], 'recruitmentDetails': "Participants with diagnosis of moderately to severely Active Crohn's disease (CD) were enrolled in the study. Participants who were biologic-naïve or biologic-experienced were enrolled in Cohort A and participants who were biologic-experienced were enrolled in Cohort B, respectively.", 'preAssignmentDetails': 'Participants who met protocol eligibility criteria were assigned to the respective Cohort and subsequently randomized in a blinded fashion in a 1:1:1 ratio to 1 of 3 treatments: filgotinib 200 milligram (mg), filgotinib 100 mg and placebo.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '223', 'groupId': 'BG000'}, {'value': '245', 'groupId': 'BG001'}, {'value': '239', 'groupId': 'BG002'}, {'value': '204', 'groupId': 'BG003'}, {'value': '230', 'groupId': 'BG004'}, {'value': '231', 'groupId': 'BG005'}, {'value': '1372', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort A: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 mg with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG001', 'title': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG002', 'title': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG003', 'title': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG004', 'title': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG005', 'title': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '213', 'groupId': 'BG000'}, {'value': '233', 'groupId': 'BG001'}, {'value': '229', 'groupId': 'BG002'}, {'value': '191', 'groupId': 'BG003'}, {'value': '220', 'groupId': 'BG004'}, {'value': '227', 'groupId': 'BG005'}, {'value': '1313', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '59', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '106', 'groupId': 'BG001'}, {'value': '130', 'groupId': 'BG002'}, {'value': '115', 'groupId': 'BG003'}, {'value': '129', 'groupId': 'BG004'}, {'value': '116', 'groupId': 'BG005'}, {'value': '706', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '113', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '109', 'groupId': 'BG002'}, {'value': '89', 'groupId': 'BG003'}, {'value': '101', 'groupId': 'BG004'}, {'value': '115', 'groupId': 'BG005'}, {'value': '666', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '27', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '214', 'groupId': 'BG000'}, {'value': '237', 'groupId': 'BG001'}, {'value': '232', 'groupId': 'BG002'}, {'value': '193', 'groupId': 'BG003'}, {'value': '217', 'groupId': 'BG004'}, {'value': '220', 'groupId': 'BG005'}, {'value': '1313', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '221', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '34', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '166', 'groupId': 'BG000'}, {'value': '179', 'groupId': 'BG001'}, {'value': '185', 'groupId': 'BG002'}, {'value': '158', 'groupId': 'BG003'}, {'value': '182', 'groupId': 'BG004'}, {'value': '178', 'groupId': 'BG005'}, {'value': '1048', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Hong Kong', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '84', 'groupId': 'BG004'}, {'value': '60', 'groupId': 'BG005'}, {'value': '303', 'groupId': 'BG006'}]}]}, {'title': 'Czechia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}]}, {'title': 'Malaysia', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}]}, {'title': 'Portugal', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}, {'title': 'Iceland', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Russia', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Austria', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Netherlands', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}]}, {'title': 'Ireland', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}, {'value': '125', 'groupId': 'BG006'}]}]}, {'title': 'Slovakia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '31', 'groupId': 'BG005'}, {'value': '130', 'groupId': 'BG006'}]}]}, {'title': 'Serbia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}]}]}, {'title': 'Croatia', 'categories': [{'measurements': [{'value': '0', 'groupId': 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'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '13', 'groupId': 'BG005'}, {'value': '61', 'groupId': 'BG006'}]}]}, {'title': 'Ukraine', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '54', 'groupId': 'BG006'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '6', 'groupId': 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'BG006'}]}]}, {'title': 'Norway', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Taiwan', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '10', 'groupId': 'BG006'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '32', 'groupId': 'BG006'}]}]}, {'title': 'South Africa', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}]}, {'title': 'Georgia', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '6', 'groupId': 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study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-02', 'size': 5362503, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-18T08:53', 'hasProtocol': True}, {'date': '2023-01-15', 'size': 10140696, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-10-18T08:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1372}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-10-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2016-09-22', 'resultsFirstSubmitDate': '2023-10-23', 'studyFirstSubmitQcDate': '2016-09-22', 'lastUpdatePostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-11-24', 'studyFirstPostDateStruct': {'date': '2016-09-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10", 'timeFrame': 'Week 10', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical remission was defined as a CDAI of \\< 150 points.'}, {'measure': 'Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10', 'timeFrame': 'Week 10', 'description': "The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score."}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58', 'timeFrame': 'Week 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical remission was defined as a CDAI of \\< 150 points.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58', 'timeFrame': 'Week 58', 'description': 'The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.'}], 'secondaryOutcomes': [{'measure': 'Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10', 'timeFrame': 'Week 10', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.'}, {'measure': 'Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10', 'timeFrame': 'Week 10', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \\< 150 points.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58', 'timeFrame': 'Week 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58', 'timeFrame': 'Week 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nClinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \\< 150 points.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58', 'timeFrame': 'Weeks 10 and 58', 'description': 'The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\nSustained Clinical Remission by CDAI: CDAI \\<150 combined at both Week 10 and Week 58.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58', 'timeFrame': 'Week 58', 'description': "The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.\n\n6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \\<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58."}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58', 'timeFrame': 'Weeks 10 and 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.\n\nSustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.'}, {'measure': 'Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58', 'timeFrame': 'Week 58', 'description': 'The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.\n\n6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.'}, {'measure': 'Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4', 'timeFrame': 'Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose', 'description': 'Plasma concentrations of filgotinib \\[nanogram/milliliters (ng/mL)\\].'}, {'measure': 'Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10', 'timeFrame': 'Week 10: Predose', 'description': 'Plasma concentrations of filgotinib (ng/mL).'}, {'measure': 'Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26', 'timeFrame': 'Week 26: At any timepoint', 'description': 'Plasma concentrations of filgotinib (ng/mL).'}, {'measure': 'Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58', 'timeFrame': 'Week 58: Pre-dose', 'description': 'Plasma concentrations of filgotinib (ng/mL).'}, {'measure': "Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4", 'timeFrame': 'Week 4: 0.5, 1, 2, and 3 hrs post dose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).'}, {'measure': "Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10", 'timeFrame': 'Week 10: Predose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).'}, {'measure': "Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26", 'timeFrame': 'Week 26: At any timepoint', 'description': 'Plasma concentrations of GS-829845 (ng/mL).'}, {'measure': "Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58", 'timeFrame': 'Week 58: Pre-dose', 'description': 'Plasma concentrations of GS-829845 (ng/mL).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crohn's Disease"]}, 'referencesModule': {'references': [{'pmid': '39637881', 'type': 'DERIVED', 'citation': "Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2."}]}, 'descriptionModule': {'briefSummary': "The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.\n\nParticipants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment\n* Moderately to severely active CD\n* Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators\n* Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab\n* Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab\n\nKey Exclusion Criteria:\n\n* Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.\n* Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon\n* Active tuberculosis (TB) or history of latent TB that has not been treated\n* Use of any prohibited concomitant medications as described in the study protocol\n\nNOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT02914561', 'acronym': 'DIVERSITY1', 'briefTitle': "Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Galapagos NV'}, 'officialTitle': "Combined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease", 'orgStudyIdInfo': {'id': 'GS-US-419-3895'}, 'secondaryIdInfos': [{'id': '2016-001367-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort A: Filgotinib 200 (mg) (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort A: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort A: Placebo (Induction Study)', 'description': 'Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: Filgotinib 200 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort B: Filgotinib 100 mg (Induction Study)', 'description': 'Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cohort B: Placebo (Induction Study)', 'description': 'Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.', 'interventionNames': ['Drug: Filgotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 200 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.', 'interventionNames': ['Drug: Filgotinib']}, {'type': 'EXPERIMENTAL', 'label': 'Filgotinib 100 mg to Placebo (Maintenance Study)', 'description': 'Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.', 'interventionNames': ['Drug: Filgotinib', 'Other: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo to Placebo (Maintenance Study)', 'description': 'Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Filgotinib', 'type': 'DRUG', 'otherNames': ['GS-6034', 'GLPG0634'], 'description': 'Filgotinib tablets administered orally once daily.', 'armGroupLabels': ['Cohort A: Filgotinib 100 mg (Induction Study)', 'Cohort A: Filgotinib 200 (mg) (Induction Study)', 'Cohort A: Placebo (Induction Study)', 'Cohort B: Filgotinib 100 mg (Induction Study)', 'Cohort B: Filgotinib 200 mg (Induction Study)', 'Cohort B: Placebo (Induction Study)', 'Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)', 'Filgotinib 100 mg to Placebo (Maintenance Study)', 'Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)', 'Filgotinib 200 mg to Placebo (Maintenance Study)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo administered orally once daily.', 'armGroupLabels': ['Cohort A: Filgotinib 100 mg (Induction Study)', 'Cohort A: Filgotinib 200 (mg) (Induction Study)', 'Cohort A: Placebo (Induction Study)', 'Cohort B: Filgotinib 100 mg (Induction Study)', 'Cohort B: Filgotinib 200 mg (Induction Study)', 'Cohort B: Placebo (Induction Study)', 'Filgotinib 100 mg to Placebo (Maintenance Study)', 'Filgotinib 200 mg to Placebo (Maintenance Study)', 'Placebo to Placebo (Maintenance Study)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36305', 'city': 'Dothan', 'state': 'Alabama', 'country': 'United States', 'facility': 'Digestive Health Specialists of the Southeast', 'geoPoint': {'lat': 31.22323, 'lon': -85.39049}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Digestive Health - Sun City', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92118', 'city': 'Coronado', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Research Center, Inc.', 'geoPoint': {'lat': 32.68589, 'lon': -117.18309}}, {'zip': '92845', 'city': 'Garden Grove', 'state': 'California', 'country': 'United States', 'facility': 'VVCRD Research', 'geoPoint': {'lat': 33.77391, 'lon': -117.94145}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health System', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92377', 'city': 'Rialto', 'state': 'California', 'country': 'United States', 'facility': 'Inland Empire Clinical Trials, LLC', 'geoPoint': {'lat': 34.1064, 'lon': -117.37032}}, {'zip': '94118', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Kaiser Permanente', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '91351', 'city': 'Santa Clarita', 'state': 'California', 'country': 'United States', 'facility': 'Clearview Medical Research, LLC', 'geoPoint': {'lat': 34.39166, 'lon': -118.54259}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Denver and Hospital', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80124', 'city': 'Lone Tree', 'state': 'Colorado', 'country': 'United States', 'facility': 'South Denver Gastroenterology, PC', 'geoPoint': {'lat': 39.55171, 'lon': -104.8863}}, {'zip': '06032', 'city': 'Farmington', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Connecticut GI, PC-Research Division', 'geoPoint': {'lat': 41.71982, 'lon': -72.83204}}, {'zip': '20007', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United 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