Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2026-04-17 @ 5:53 AM
Study NCT ID:
NCT02819635
Status:
COMPLETED
Last Update Posted:
2022-06-30
First Post:
2016-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Egypt', 'Romania']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'abbvieclinicaltrials@abbvie.com', 'phone': '800-633-9110', 'title': 'Global Medical Services', 'organization': 'AbbVie'}, 'certainAgreement': {'otherDetails': 'AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All-cause mortality is reported from enrollment to end of study; median time on follow-up was up to 57, 61, and 364 days for Substudies 1, 2, and 3, respectively. TEAEs and SAEs were collected from first dose of study drug until 30 days after last dose of study drug; mean duration on study drug was up to 57, 56, and 364 days for Substudies 1, 2, and 3, respectively.', 'description': 'For safety analyses, participants were assigned to a treatment group based on the treatment actually received, regardless of the treatment randomized. The "as treated" group was determined by the most frequent dose regimen received in the analysis period.', 'eventGroups': [{'id': 'EG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 27, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 18, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 22, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.', 'otherNumAtRisk': 117, 'deathsNumAtRisk': 117, 'otherNumAffected': 58, 'seriousNumAtRisk': 117, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.', 'otherNumAtRisk': 123, 'deathsNumAtRisk': 123, 'otherNumAffected': 50, 'seriousNumAtRisk': 123, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG005', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'otherNumAtRisk': 155, 'deathsNumAtRisk': 155, 'otherNumAffected': 62, 'seriousNumAtRisk': 155, 'deathsNumAffected': 0, 'seriousNumAffected': 9}, {'id': 'EG006', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'otherNumAtRisk': 319, 'deathsNumAtRisk': 319, 'otherNumAffected': 121, 'seriousNumAtRisk': 319, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG007', 'title': 'SS2: Placebo/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.', 'otherNumAtRisk': 85, 'deathsNumAtRisk': 85, 'otherNumAffected': 36, 'seriousNumAtRisk': 85, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG008', 'title': 'SS2: Upadacitinib 45 mg/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.', 'otherNumAtRisk': 59, 'deathsNumAtRisk': 59, 'otherNumAffected': 17, 'seriousNumAtRisk': 59, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG009', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.', 'otherNumAtRisk': 385, 'deathsNumAtRisk': 385, 'otherNumAffected': 216, 'seriousNumAtRisk': 385, 'deathsNumAffected': 0, 'seriousNumAffected': 32}, {'id': 'EG010', 'title': 'SS3: Upadacitinib 7.5 mg', 'description': 'Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 18, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG011', 'title': 'SS3: Upadacitinib 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.', 'otherNumAtRisk': 323, 'deathsNumAtRisk': 323, 'otherNumAffected': 181, 'seriousNumAtRisk': 323, 'deathsNumAffected': 0, 'seriousNumAffected': 24}, {'id': 'EG012', 'title': 'SS3: Upadacitinib 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.', 'otherNumAtRisk': 316, 'deathsNumAtRisk': 316, 'otherNumAffected': 166, 'seriousNumAtRisk': 316, 'deathsNumAffected': 0, 'seriousNumAffected': 25}], 'otherEvents': [{'term': 'ANAEMIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 9, 'numAffected': 9}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 24, 'numAffected': 20}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'LYMPHOPENIA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'CERUMEN IMPACTION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'CATARACT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'VISUAL IMPAIRMENT', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ABDOMINAL DISTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ABDOMINAL PAIN', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ABDOMINAL TENDERNESS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'APHTHOUS ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COLITIS ULCERATIVE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 16, 'numAffected': 16}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 110, 'numAffected': 101}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 47, 'numAffected': 40}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 25, 'numAffected': 24}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'CONSTIPATION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'DIARRHOEA', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 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'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ACUTE RESPIRATORY FAILURE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'CHRONIC OBSTRUCTIVE PULMONARY DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'INTERSTITIAL LUNG DISEASE', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'NONINFECTIVE BRONCHITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'PULMONARY EMBOLISM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ERYTHEMA NODOSUM', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'PANNICULITIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'SKIN ULCER', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'ABORTION INDUCED', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'DEEP VEIN THROMBOSIS', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'HYPOTENSION', 'stats': [{'groupId': 'EG000', 'numAtRisk': 46, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 117, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 123, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 155, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 319, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 85, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 385, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 323, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG012', 'numAtRisk': 316, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8.5', 'groupId': 'OG001'}, {'value': '14.3', 'groupId': 'OG002'}, {'value': '13.5', 'groupId': 'OG003'}, {'value': '21.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.049', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.4', 'ciLowerLimit': '0.0', 'ciUpperLimit': '16.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.010', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.5', 'ciLowerLimit': '3.3', 'ciUpperLimit': '23.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.007', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.8', 'ciLowerLimit': '3.8', 'ciUpperLimit': '23.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.1', 'ciLowerLimit': '8.6', 'ciUpperLimit': '33.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS1 main population (ITT1A): those randomized to ≥1 dose of study drug during the initial part of SS1. Non-responder imputation (NRI) was used to impute missing values.'}, {'type': 'PRIMARY', 'title': 'Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.8', 'groupId': 'OG000'}, {'value': '26.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.6', 'ciLowerLimit': '15.8', 'ciUpperLimit': '27.4', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes vs. no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS2, Part 1 population (ITT1): all randomized participants in the 8-week double-blind induction period who received ≥1 dose of study drug. NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used for SS2, with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'PRIMARY', 'title': 'Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000', 'lowerLimit': '6.9', 'upperLimit': '17.4'}, {'value': '42.3', 'groupId': 'OG001', 'lowerLimit': '34.3', 'upperLimit': '50.3'}, {'value': '51.7', 'groupId': 'OG002', 'lowerLimit': '43.6', 'upperLimit': '59.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '30.7', 'ciLowerLimit': '21.7', 'ciUpperLimit': '39.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.0', 'ciLowerLimit': '29.7', 'ciUpperLimit': '48.2', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Baseline of Induction Study; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.2', 'groupId': 'OG000'}, {'value': '14.9', 'groupId': 'OG001'}, {'value': '30.6', 'groupId': 'OG002'}, {'value': '26.9', 'groupId': 'OG003'}, {'value': '35.7', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.030', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.1', 'ciLowerLimit': '1.2', 'ciUpperLimit': '25.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.6', 'ciLowerLimit': '13.1', 'ciUpperLimit': '42.1', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.6', 'ciLowerLimit': '12.3', 'ciUpperLimit': '40.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.4', 'ciLowerLimit': '19.2', 'ciUpperLimit': '51.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10.6', 'groupId': 'OG001'}, {'value': '10.2', 'groupId': 'OG002'}, {'value': '11.5', 'groupId': 'OG003'}, {'value': '19.6', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.021', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.0', 'ciLowerLimit': '1.7', 'ciUpperLimit': '20.4', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.024', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.6', 'ciLowerLimit': '1.3', 'ciUpperLimit': '18.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.2', 'ciLowerLimit': '2.3', 'ciUpperLimit': '22.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '20.1', 'ciLowerLimit': '8.0', 'ciUpperLimit': '32.1', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \\[confirmed by a central reader\\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000'}, {'value': '29.8', 'groupId': 'OG001'}, {'value': '49.0', 'groupId': 'OG002'}, {'value': '46.2', 'groupId': 'OG003'}, {'value': '55.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.7', 'ciLowerLimit': '0.9', 'ciUpperLimit': '32.5', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.2', 'ciLowerLimit': '17.5', 'ciUpperLimit': '52.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.6', 'ciLowerLimit': '16.3', 'ciUpperLimit': '50.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '26.2', 'ciUpperLimit': '63.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000'}, {'value': '23.4', 'groupId': 'OG001'}, {'value': '34.7', 'groupId': 'OG002'}, {'value': '36.5', 'groupId': 'OG003'}, {'value': '55.4', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.495', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-11.1', 'ciUpperLimit': '22.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.074', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '15.9', 'ciLowerLimit': '-1.6', 'ciUpperLimit': '33.4', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.033', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.2', 'ciLowerLimit': '1.6', 'ciUpperLimit': '36.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '40.1', 'ciLowerLimit': '20.5', 'ciUpperLimit': '59.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2', 'description': 'The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n\nThe overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.\n\nClinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Change in Full Mayo Score From Baseline to Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '44', 'groupId': 'OG002'}, {'value': '44', 'groupId': 'OG003'}, {'value': '48', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.741', 'spread': '2.3302', 'groupId': 'OG000'}, {'value': '-2.870', 'spread': '2.9685', 'groupId': 'OG001'}, {'value': '-3.589', 'spread': '2.4984', 'groupId': 'OG002'}, {'value': '-4.211', 'spread': '3.0886', 'groupId': 'OG003'}, {'value': '-4.606', 'spread': '2.8976', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.142', 'ciLowerLimit': '-3.2323', 'ciUpperLimit': '-1.0520', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\\<= 7 and \\> 7)), and Baseline value as covariate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.938', 'ciLowerLimit': '-4.0284', 'ciUpperLimit': '-1.8478', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\\<= 7 and \\> 7)), and Baseline value as covariate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.736', 'ciLowerLimit': '-4.8247', 'ciUpperLimit': '-2.6470', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\\<= 7 and \\> 7)), and Baseline value as covariate.'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.061', 'ciLowerLimit': '-5.1252', 'ciUpperLimit': '-2.9974', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, Baseline corticosteroid use, Baseline Adapted Mayo score (\\<= 7 and \\> 7)), and Baseline value as covariate.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \\[confirmed by a central reader\\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Last observation carried forward (LOCF) was used for missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}, {'value': '4.1', 'groupId': 'OG002'}, {'value': '9.6', 'groupId': 'OG003'}, {'value': '17.9', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.075', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.6', 'ciLowerLimit': '-0.7', 'ciUpperLimit': '13.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.199', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '3.8', 'ciLowerLimit': '-2.0', 'ciUpperLimit': '9.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.015', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.1', 'ciLowerLimit': '2.2', 'ciUpperLimit': '20.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '0.004', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.8', 'ciLowerLimit': '5.8', 'ciUpperLimit': '29.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '49', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '56', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'OG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.5', 'groupId': 'OG000'}, {'value': '31.9', 'groupId': 'OG001'}, {'value': '51.0', 'groupId': 'OG002'}, {'value': '44.2', 'groupId': 'OG003'}, {'value': '48.2', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '25.6', 'ciLowerLimit': '8.9', 'ciUpperLimit': '42.3', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 7.5 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 7.5 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.6', 'ciLowerLimit': '25.4', 'ciUpperLimit': '61.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG003'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '39.4', 'ciLowerLimit': '21.3', 'ciUpperLimit': '57.5', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG004'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '43.1', 'ciLowerLimit': '24.4', 'ciUpperLimit': '61.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 1: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by previous biologic use, baseline corticosteroid use and baseline Adapted Mayo score (≤ 7 and \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.\n\nHistologic improvement was defined as decrease from baseline in Geboes score.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 1 main population (ITT1A) includes participants who were randomized to at least one dose (placebo or upadacitinib 7.5 mg, 15 mg, 30 mg, 45 mg) during the main (initial) part of Substudy 1. Non-responder imputation (NRI) was used to impute missing values for the ITT1A population.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.4', 'groupId': 'OG000', 'lowerLimit': '3.2', 'upperLimit': '11.5'}, {'value': '36.3', 'groupId': 'OG001', 'lowerLimit': '31.0', 'upperLimit': '41.7'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '29.3', 'ciLowerLimit': '22.6', 'ciUpperLimit': '35.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '13.7', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '17.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '12.7', 'ciLowerLimit': '8.4', 'ciUpperLimit': '17.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '34.3'}, {'value': '72.6', 'groupId': 'OG001', 'lowerLimit': '67.7', 'upperLimit': '77.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.3', 'ciLowerLimit': '38.4', 'ciUpperLimit': '54.2', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.3', 'groupId': 'OG000', 'lowerLimit': '20.2', 'upperLimit': '34.3'}, {'value': '60.1', 'groupId': 'OG001', 'lowerLimit': '54.7', 'upperLimit': '65.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.3', 'ciLowerLimit': '24.8', 'ciUpperLimit': '41.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)', 'otherAnalysisDescription': 'Difference = Upadacitinib 45 mg - Placebo'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 2', 'description': 'The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n\nThe overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.\n\nClinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'groupId': 'OG000', 'lowerLimit': '2.6', 'upperLimit': '10.5'}, {'value': '30.1', 'groupId': 'OG001', 'lowerLimit': '25.0', 'upperLimit': '35.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.7', 'ciLowerLimit': '17.5', 'ciUpperLimit': '30.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.\n\nThe endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.4', 'groupId': 'OG000', 'lowerLimit': '14.9', 'upperLimit': '27.9'}, {'value': '48.4', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '53.9'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '27.4', 'ciLowerLimit': '19.2', 'ciUpperLimit': '35.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Bowel urgency was assessed by participants in a subject diary completed once a day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '16.7', 'upperLimit': '30.1'}, {'value': '46.6', 'groupId': 'OG001', 'lowerLimit': '41.1', 'upperLimit': '52.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.6', 'ciLowerLimit': '15.1', 'ciUpperLimit': '32.1', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Abdominal pain was assessed by participants in a subject diary completed once a day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000', 'lowerLimit': '15.9', 'upperLimit': '29.1'}, {'value': '55.0', 'groupId': 'OG001', 'lowerLimit': '49.5', 'upperLimit': '60.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '32.2', 'ciLowerLimit': '23.8', 'ciUpperLimit': '40.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by bio-IR status (bio-IR vs. non-bio-IR), Baseline corticosteroid use (yes or no) and Baseline Adapted Mayo score (≤ 7 vs. \\> 7)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '292', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '21.7', 'groupId': 'OG000', 'lowerLimit': '16.03', 'upperLimit': '27.28'}, {'value': '55.3', 'groupId': 'OG001', 'lowerLimit': '51.54', 'upperLimit': '59.15'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.7', 'ciLowerLimit': '27.02', 'ciUpperLimit': '40.36', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.39', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Mixed-effect model repeated measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status).'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '154', 'groupId': 'OG000'}, {'value': '319', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '3.1'}, {'value': '10.7', 'groupId': 'OG001', 'lowerLimit': '7.3', 'upperLimit': '14.1'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.7', 'ciLowerLimit': '5.7', 'ciUpperLimit': '13.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Baseline corticosteroid use (yes or no), Baseline Adapted Mayo score (≤ 7 or \\> 7), and bio-IR status (bio-IR or non-bio-IR)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 8', 'description': 'Mucosal healing is defined as an endoscopic score of 0 and Geboes score \\< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 population (ITT1) includes all randomized participants in the 8-week double-blind induction period who received at least one dose of double-blinded study drug in Part 1; NRI incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used with participants analyzed according to treatment groups to which they were randomized.'}, {'type': 'SECONDARY', 'title': 'Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '125', 'groupId': 'OG000'}, {'value': '291', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'SS2: Placebo', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'OG001', 'title': 'SS2: Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'groupId': 'OG000', 'lowerLimit': '1.23', 'upperLimit': '4.44'}, {'value': '9.5', 'groupId': 'OG001', 'lowerLimit': '8.44', 'upperLimit': '10.61'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares (LS) Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.7', 'ciLowerLimit': '4.79', 'ciUpperLimit': '8.59', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with multiplicity adjustment using a fixed-sequence multiple testing procedure to ensure a strong control of family-wise type I error rate at significance level alpha = 0.05 (2-sided).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.97', 'estimateComment': 'Difference = Upadacitinib 45 mg - Placebo', 'groupDescription': 'Substudy 2: Upadacitinib 45 mg vs Placebo', 'statisticalMethod': 'Mixed-effect model repeated measurement', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'MMRM with Baseline, treatment, visit, treatment-by-visit interaction, and strata (Baseline Adapted Mayo score, corticosteroid use, and bio-IR status)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': 'The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The Substudy 2, Part 1 ITT1 population with available data; a mixed effect model repeat measurement (MMRM) analysis with data from observed cases up to Week 8 was used except for measurements at or after the occurrence of UC-related corticosteroids intercurrent event were excluded'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'groupId': 'OG000', 'lowerLimit': '8.7', 'upperLimit': '20.3'}, {'value': '48.7', 'groupId': 'OG001', 'lowerLimit': '40.5', 'upperLimit': '56.8'}, {'value': '61.6', 'groupId': 'OG002', 'lowerLimit': '53.6', 'upperLimit': '69.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '34.4', 'ciLowerLimit': '25.1', 'ciUpperLimit': '43.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '46.3', 'ciLowerLimit': '36.7', 'ciUpperLimit': '55.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '33.3'}, {'value': '59.2', 'groupId': 'OG001', 'lowerLimit': '45.1', 'upperLimit': '73.4'}, {'value': '69.7', 'groupId': 'OG002', 'lowerLimit': '57.7', 'upperLimit': '81.8'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.4', 'ciLowerLimit': '20.3', 'ciUpperLimit': '54.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '47.0', 'ciLowerLimit': '30.7', 'ciUpperLimit': '63.3', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.2', 'groupId': 'OG000', 'lowerLimit': '11.1', 'upperLimit': '33.3'}, {'value': '57.1', 'groupId': 'OG001', 'lowerLimit': '42.9', 'upperLimit': '71.3'}, {'value': '68.0', 'groupId': 'OG002', 'lowerLimit': '55.8', 'upperLimit': '80.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '35.4', 'ciLowerLimit': '18.2', 'ciUpperLimit': '52.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '28.7', 'ciUpperLimit': '61.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical remission per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}, {'value': '79', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'groupId': 'OG000', 'lowerLimit': '9.9', 'upperLimit': '28.4'}, {'value': '61.6', 'groupId': 'OG001', 'lowerLimit': '49.6', 'upperLimit': '73.7'}, {'value': '69.5', 'groupId': 'OG002', 'lowerLimit': '59.1', 'upperLimit': '80.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '42.0', 'ciLowerLimit': '27.8', 'ciUpperLimit': '56.2', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '48.6', 'ciLowerLimit': '35.5', 'ciUpperLimit': '61.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved endoscopic improvement in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '1.8', 'upperLimit': '9.3'}, {'value': '24.2', 'groupId': 'OG001', 'lowerLimit': '17.3', 'upperLimit': '31.2'}, {'value': '25.9', 'groupId': 'OG002', 'lowerLimit': '18.8', 'upperLimit': '33.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '18.7', 'ciLowerLimit': '11.0', 'ciUpperLimit': '26.4', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '19.4', 'ciLowerLimit': '11.7', 'ciUpperLimit': '27.2', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}, {'value': '144', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '18.8', 'groupId': 'OG000', 'lowerLimit': '12.1', 'upperLimit': '25.5'}, {'value': '63.0', 'groupId': 'OG001', 'lowerLimit': '54.8', 'upperLimit': '71.1'}, {'value': '76.6', 'groupId': 'OG002', 'lowerLimit': '69.6', 'upperLimit': '83.6'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '44.6', 'ciLowerLimit': '34.5', 'ciUpperLimit': '54.7', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '56.6', 'ciLowerLimit': '47.2', 'ciUpperLimit': '66.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1 and who achieved clinical response per Adapted Mayo Score in Substudy 1, 2, or M14-675. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '11.9', 'groupId': 'OG000', 'lowerLimit': '6.7', 'upperLimit': '17.2'}, {'value': '35.0', 'groupId': 'OG001', 'lowerLimit': '27.1', 'upperLimit': '42.8'}, {'value': '49.8', 'groupId': 'OG002', 'lowerLimit': '41.5', 'upperLimit': '58.0'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '23.8', 'ciLowerLimit': '14.8', 'ciUpperLimit': '32.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '37.3', 'ciLowerLimit': '27.8', 'ciUpperLimit': '46.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.\n\nThe endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.9', 'groupId': 'OG000', 'lowerLimit': '10.79', 'upperLimit': '25.00'}, {'value': '49.2', 'groupId': 'OG001', 'lowerLimit': '42.59', 'upperLimit': '55.89'}, {'value': '58.9', 'groupId': 'OG002', 'lowerLimit': '52.14', 'upperLimit': '65.59'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '31.3', 'ciLowerLimit': '21.98', 'ciUpperLimit': '40.70', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.77', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '41.0', 'ciLowerLimit': '31.39', 'ciUpperLimit': '50.55', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.88', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/ no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0), Week 52', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000', 'lowerLimit': '1.3', 'upperLimit': '8.2'}, {'value': '17.6', 'groupId': 'OG001', 'lowerLimit': '11.4', 'upperLimit': '23.8'}, {'value': '19.0', 'groupId': 'OG002', 'lowerLimit': '12.6', 'upperLimit': '25.4'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.0', 'ciLowerLimit': '6.0', 'ciUpperLimit': '20.0', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '13.6', 'ciLowerLimit': '6.6', 'ciUpperLimit': '20.6', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Mucosal healing is defined as an endoscopic score of 0 and Geboes score \\< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '17.4', 'groupId': 'OG000', 'lowerLimit': '11.4', 'upperLimit': '23.5'}, {'value': '56.1', 'groupId': 'OG001', 'lowerLimit': '48.1', 'upperLimit': '64.1'}, {'value': '63.6', 'groupId': 'OG002', 'lowerLimit': '56.0', 'upperLimit': '71.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.7', 'ciLowerLimit': '28.9', 'ciUpperLimit': '48.5', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '45.1', 'ciLowerLimit': '35.5', 'ciUpperLimit': '54.8', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Bowel urgency was assessed by participants in a subject diary completed once a day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '20.8', 'groupId': 'OG000', 'lowerLimit': '14.2', 'upperLimit': '27.3'}, {'value': '45.9', 'groupId': 'OG001', 'lowerLimit': '37.9', 'upperLimit': '54.0'}, {'value': '55.3', 'groupId': 'OG002', 'lowerLimit': '47.4', 'upperLimit': '63.2'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '24.3', 'ciLowerLimit': '14.2', 'ciUpperLimit': '34.5', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'Adjusted risk difference (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.7', 'ciLowerLimit': '23.6', 'ciUpperLimit': '43.9', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by Bio-IR (Bio-IR/Non-Bio-IR) at Induction Study Baseline; clinical remission at Week 0 (yes/no); corticosteroid use at Week 0 (yes/no)'}], 'paramType': 'NUMBER', 'timeFrame': 'At Week 52', 'description': 'Abdominal pain was assessed by participants in a subject diary completed once a day.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population: the first 451 upadacitinib 45 mg 8-week induction responders who were enrolled under the protocol for 52-week maintenance treatment period in Cohort 1. Non-responder imputation incorporating multiple imputation (MI) to handle missing data due to COVID-19 (NRI-C) was used to handle missing data.'}, {'type': 'SECONDARY', 'title': 'Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '154', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8, while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'OG001', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks'}, {'id': 'OG002', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at Week 8 while receiving upadacitinib 15, 30, or 45 mg QD and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'groupId': 'OG000', 'lowerLimit': '1.88', 'upperLimit': '5.43'}, {'value': '8.7', 'groupId': 'OG001', 'lowerLimit': '7.01', 'upperLimit': '10.49'}, {'value': '9.5', 'groupId': 'OG002', 'lowerLimit': '7.80', 'upperLimit': '11.22'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.1', 'ciLowerLimit': '2.67', 'ciUpperLimit': '7.52', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 15 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 15 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)'}, {'pValue': '<0.001', 'groupIds': ['OG000', 'OG002'], 'paramType': 'LS Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '3.44', 'ciUpperLimit': '8.27', 'pValueComment': 'The primary and ranked secondary efficacy endpoints were tested with graphical multiplicity adjustment to ensure a strong control of family-wise type I error rate at significance level α= 0.05 (2-sided).', 'estimateComment': 'Difference = Upadacitinib 30 mg - Placebo', 'groupDescription': 'Substudy 3: Upadacitinib 30 mg vs Placebo', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Stratified by corticosteroid use at Week 0 (yes/no); clinical remission status at Week 0 (yes/no); Bio-IR status at Baseline (Bio-IR or Non-Bio-IR)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (Week 0), Week 52', 'description': 'The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Substudy 3 ITT\\_A population with available data: Baseline is defined as the last non-missing value prior to the first dose in Phase 2b Induction or Induction Studies. Multiple Imputation Incorporating Return-to-Baseline (RTB-MI) was used to handle missing data.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'FG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'FG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'FG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'FG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'FG005', 'title': 'SS2: Placebo/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.'}, {'id': 'FG006', 'title': 'SS2: Upadacitinib 45 mg/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.'}, {'id': 'FG007', 'title': 'SS3: M14-675 Clinical Responders', 'description': 'Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \\[QD\\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.'}, {'id': 'FG008', 'title': 'SS3: Placebo', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to placebo QD in Substudy 3 for up to 52 weeks. In addition, participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3 for up to 52 weeks.'}, {'id': 'FG009', 'title': 'SS3: UPA 7.5 mg', 'description': 'Participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3 for up to 52 weeks.'}, {'id': 'FG010', 'title': 'SS3: UPA 15 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 15 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 15 mg QD in Substudy 3.'}, {'id': 'FG011', 'title': 'SS3: UPA 30 mg', 'description': 'Participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, while receiving upadacitinib 15, 30, or 45 mg QD and those who achieved clinical response while receiving upadacitinib 15 mg QD in Substudy 1 and were randomized to upadacitinib 30 mg QD in Substudy 3 for up to 52 weeks. In addition, participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 and were randomized to upadacitinib 30 mg QD in Substudy 3.'}], 'periods': [{'title': 'Substudy 1 and Substudy 2, Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '46'}, {'groupId': 'FG001', 'numSubjects': '47'}, {'groupId': 'FG002', 'numSubjects': '49'}, {'groupId': 'FG003', 'numSubjects': '117'}, {'groupId': 'FG004', 'numSubjects': '123'}, {'groupId': 'FG005', 'numSubjects': '155'}, {'groupId': 'FG006', 'numSubjects': '319'}, {'groupId': 'FG007', 'numSubjects': '446'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '45'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '113'}, {'groupId': 'FG005', 'numSubjects': '135'}, {'groupId': 'FG006', 'numSubjects': '306'}, {'groupId': 'FG007', 'numSubjects': '446'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '12'}, {'groupId': 'FG004', 'numSubjects': '10'}, {'groupId': 'FG005', 'numSubjects': '20'}, {'groupId': 'FG006', 'numSubjects': '13'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '9'}, {'groupId': 'FG006', 'numSubjects': '6'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'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': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COVID-19 Logistical Restrictions', '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'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '7'}, {'groupId': 'FG006', 'numSubjects': '3'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Substudy 2, Part 2', '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': '85'}, {'groupId': 'FG006', 'numSubjects': '59'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'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': '74'}, {'groupId': 'FG006', 'numSubjects': '47'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'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': '11'}, {'groupId': 'FG006', 'numSubjects': '12'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}], 'dropWithdraws': [{'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': '4'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'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': '1'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'COVID-19 Logistical Restrictions', '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': '2'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}, {'type': 'Other, not specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}, {'groupId': 'FG006', 'numSubjects': '8'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '0'}]}]}, {'title': 'Substudy 3', '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'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '386'}, {'groupId': 'FG009', 'numSubjects': '20'}, {'groupId': 'FG010', 'numSubjects': '324'}, {'groupId': 'FG011', 'numSubjects': '316'}]}, {'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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '140'}, {'groupId': 'FG009', 'numSubjects': '11'}, {'groupId': 'FG010', 'numSubjects': '218'}, {'groupId': 'FG011', 'numSubjects': '248'}]}, {'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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '246'}, {'groupId': 'FG009', 'numSubjects': '9'}, {'groupId': 'FG010', 'numSubjects': '106'}, {'groupId': 'FG011', 'numSubjects': '68'}]}], 'dropWithdraws': [{'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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '32'}, {'groupId': 'FG009', 'numSubjects': '3'}, {'groupId': 'FG010', 'numSubjects': '12'}, {'groupId': 'FG011', 'numSubjects': '18'}]}, {'type': 'Withdrew consent', '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': '11'}, {'groupId': 'FG009', 'numSubjects': '1'}, {'groupId': 'FG010', 'numSubjects': '4'}, {'groupId': 'FG011', 'numSubjects': '9'}]}, {'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': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '1'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'COVID-19 Logistical Restrictions', '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': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}, {'groupId': 'FG010', 'numSubjects': '0'}, {'groupId': 'FG011', 'numSubjects': '1'}]}, {'type': 'Other, not specified', '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': '202'}, {'groupId': 'FG009', 'numSubjects': '5'}, {'groupId': 'FG010', 'numSubjects': '89'}, {'groupId': 'FG011', 'numSubjects': '39'}]}]}], 'preAssignmentDetails': 'Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all participants who received at least one dose of study drug in Substudy 3)'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'groups': [{'id': 'BG000', 'title': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'BG001', 'title': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'BG002', 'title': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.'}, {'id': 'BG003', 'title': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'BG004', 'title': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.'}, {'id': 'BG005', 'title': 'SS2: Placebo/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.'}, {'id': 'BG006', 'title': 'SS2: Upadacitinib 45 mg/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.'}, {'id': 'BG007', 'title': 'SS3: M14-675 Clinical Responders', 'description': 'Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \\[QD\\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.'}, {'id': 'BG008', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '42.3', 'spread': '13.29', 'groupId': 'BG000'}, {'value': '41.7', 'spread': '14.58', 'groupId': 'BG001'}, {'value': '46.0', 'spread': '13.58', 'groupId': 'BG002'}, {'value': '42.9', 'spread': '14.44', 'groupId': 'BG003'}, {'value': '41.6', 'spread': '14.19', 'groupId': 'BG004'}, {'value': '44.3', 'spread': '14.64', 'groupId': 'BG005'}, {'value': '43.6', 'spread': '14.04', 'groupId': 'BG006'}, {'value': '42.1', 'spread': '14.42', 'groupId': 'BG007'}, {'value': '42.9', 'spread': '14.27', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '121', 'groupId': 'BG006'}, {'value': '170', 'groupId': 'BG007'}, {'value': '500', 'groupId': 'BG008'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '70', 'groupId': 'BG003'}, {'value': '79', 'groupId': 'BG004'}, {'value': '97', 'groupId': 'BG005'}, {'value': '198', 'groupId': 'BG006'}, {'value': '276', 'groupId': 'BG007'}, {'value': '802', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}, {'value': '90', 'groupId': 'BG004'}, {'value': '101', 'groupId': 'BG005'}, {'value': '206', 'groupId': 'BG006'}, {'value': '302', 'groupId': 'BG007'}, {'value': '898', 'groupId': 'BG008'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '12', 'groupId': 'BG006'}, {'value': '15', 'groupId': 'BG007'}, {'value': '40', 'groupId': 'BG008'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '28', 'groupId': 'BG004'}, {'value': '46', 'groupId': 'BG005'}, {'value': '95', 'groupId': 'BG006'}, {'value': '124', 'groupId': 'BG007'}, {'value': '341', 'groupId': 'BG008'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '4', 'groupId': 'BG008'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'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': '1', 'groupId': 'BG006'}, {'value': '1', 'groupId': 'BG007'}, {'value': '2', 'groupId': 'BG008'}]}]}, {'title': 'Multiple', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}, {'value': '17', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Average Stool Frequency Subscore', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '318', 'groupId': 'BG006'}, {'value': '445', 'groupId': 'BG007'}, {'value': '1299', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '2.56', 'spread': '0.667', 'groupId': 'BG000'}, {'value': '2.62', 'spread': '0.600', 'groupId': 'BG001'}, {'value': '2.68', 'spread': '0.565', 'groupId': 'BG002'}, {'value': '2.61', 'spread': '0.613', 'groupId': 'BG003'}, {'value': '2.58', 'spread': '0.648', 'groupId': 'BG004'}, {'value': '2.52', 'spread': '0.668', 'groupId': 'BG005'}, {'value': '2.60', 'spread': '0.624', 'groupId': 'BG006'}, {'value': '2.55', 'spread': '0.623', 'groupId': 'BG007'}, {'value': '2.58', 'spread': '0.628', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Participants recorded stool frequency using an electronic subject diary on a daily basis. The stool frequency subscore (SFS) ranges from 0 to 3 according to the following scale:\n\nScore 0: Normal number of stools\n\nScore 1: 1 to 2 stools more than normal\n\nScore 2: 3 to 4 stools more than normal\n\nScore 3: 5 or more stools more than normal', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Average Rectal Bleeding Subscore', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '318', 'groupId': 'BG006'}, {'value': '445', 'groupId': 'BG007'}, {'value': '1299', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '1.66', 'spread': '1.034', 'groupId': 'BG000'}, {'value': '1.61', 'spread': '1.027', 'groupId': 'BG001'}, {'value': '1.55', 'spread': '0.915', 'groupId': 'BG002'}, {'value': '1.51', 'spread': '0.975', 'groupId': 'BG003'}, {'value': '1.49', 'spread': '0.960', 'groupId': 'BG004'}, {'value': '1.76', 'spread': '0.994', 'groupId': 'BG005'}, {'value': '1.71', 'spread': '1.046', 'groupId': 'BG006'}, {'value': '1.77', 'spread': '0.990', 'groupId': 'BG007'}, {'value': '1.68', 'spread': '1.003', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Participants recorded rectal bleeding in an electronic subject diary on a daily basis. The rectal bleeding subscore ranges from 0 to 3 according to the following scale:\n\nScore 0: No blood seen\n\nScore 1: Streaks of blood with stool less than half the time\n\nScore 2: Obvious blood with stool most of the time\n\nScore 3: Blood alone passed', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Participants with available data'}, {'title': 'Average Endoscopy Subscore', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '0.43', 'groupId': 'BG000'}, {'value': '2.8', 'spread': '0.40', 'groupId': 'BG001'}, {'value': '2.8', 'spread': '0.39', 'groupId': 'BG002'}, {'value': '2.7', 'spread': '0.47', 'groupId': 'BG003'}, {'value': '2.7', 'spread': '0.48', 'groupId': 'BG004'}, {'value': '2.7', 'spread': '0.47', 'groupId': 'BG005'}, {'value': '2.7', 'spread': '0.46', 'groupId': 'BG006'}, {'value': '2.7', 'spread': '0.47', 'groupId': 'BG007'}, {'value': '2.7', 'spread': '0.46', 'groupId': 'BG008'}]}]}], 'paramType': 'MEAN', 'description': 'Findings on endoscopy were scored according to the following:\n\nScore 0: Normal or inactive disease\n\nScore 1: Mild disease (erythema, decreased vascular pattern)\n\nScore 2: Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions)\n\nScore 3: Severe disease (spontaneous bleeding, ulceration)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Previous Biologic Use', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '382', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}, {'value': '87', 'groupId': 'BG003'}, {'value': '92', 'groupId': 'BG004'}, {'value': '288', 'groupId': 'BG008'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}, {'value': '382', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '31', 'groupId': 'BG004'}, {'value': '94', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with available data'}, {'title': 'Biologic-inadequate Responder (Bio-IR) Status', 'classes': [{'title': 'Bio-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '920', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '79', 'groupId': 'BG005'}, {'value': '168', 'groupId': 'BG006'}, {'value': '221', 'groupId': 'BG007'}, {'value': '468', 'groupId': 'BG008'}]}]}, {'title': 'Non-Bio-IR', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '920', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '76', 'groupId': 'BG005'}, {'value': '151', 'groupId': 'BG006'}, {'value': '225', 'groupId': 'BG007'}, {'value': '452', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Biologic-inadequate responders (Bio-IR) are defined as participants who had inadequate response, loss of response, or intolerance to biologic therapy.\n\nNon-biologic-inadequate responders (non-bio-IR) are defined as participants who had inadequate response, loss of response, or intolerance to conventional therapy but had not failed biologic therapy.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'populationDescription': 'Participants with available data'}, {'title': 'Baseline Corticosteroid Use', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '27', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '124', 'groupId': 'BG006'}, {'value': '173', 'groupId': 'BG007'}, {'value': '540', 'groupId': 'BG008'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '117', 'groupId': 'BG003'}, {'value': '123', 'groupId': 'BG004'}, {'value': '155', 'groupId': 'BG005'}, {'value': '319', 'groupId': 'BG006'}, {'value': '446', 'groupId': 'BG007'}, {'value': '1302', 'groupId': 'BG008'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}, {'value': '66', 'groupId': 'BG003'}, {'value': '70', 'groupId': 'BG004'}, {'value': '93', 'groupId': 'BG005'}, {'value': '195', 'groupId': 'BG006'}, {'value': '273', 'groupId': 'BG007'}, {'value': '762', 'groupId': 'BG008'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Intent-to-treat (ITT) analysis set: Substudy 1 (all randomized participants who received at least one dose of study drug in Substudy 1); Substudy 2 (all randomized participants who received at least one dose of doubleblinded study drug in Part 1 and all participants who received at least one dose of upadacitinib 45 mg in Part 2); Substudy 3 (all M14-675 participants who received at least one dose of study drug in Substudy 3)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-10', 'size': 7366952, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-03T12:37', 'hasProtocol': True}, {'date': '2021-05-20', 'size': 2666715, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-03T12:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1302}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-03', 'studyFirstSubmitDate': '2016-06-28', 'resultsFirstSubmitDate': '2022-06-03', 'studyFirstSubmitQcDate': '2016-06-28', 'lastUpdatePostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-06-03', 'studyFirstPostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Substudy 1: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 1, clinical remission is defined as SFS ≤ 1, RBS of 0, and endoscopic subscore ≤ 1.'}, {'measure': 'Substudy 2: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal)\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed)\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration)\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 2, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In Substudy 2, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.'}, {'measure': 'Substudy 3: Percentage Of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Week 52', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.'}], 'secondaryOutcomes': [{'measure': 'Substudy 1: Percentage Of Participants With Endoscopic Improvement at Week 8', 'timeFrame': 'At Week 8', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 1: Percentage Of Participants Achieving Clinical Remission Per Full Mayo Score at Week 8', 'timeFrame': 'At Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \\[confirmed by a central reader\\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1."}, {'measure': 'Substudy 1: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).'}, {'measure': 'Substudy 1: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2', 'timeFrame': 'At Week 2', 'description': 'The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n\nThe overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.\n\nClinical response per Partial Mayo Score is defined as a decrease in Partial Adapted Mayo score ≥ 2 points and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.'}, {'measure': 'Substudy 1: Change in Full Mayo Score From Baseline to Week 8', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': "The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The Full Mayo score (FMS) ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \\[confirmed by a central reader\\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \\> 1."}, {'measure': 'Substudy 1: Percentage Of Participants With Endoscopic Remission at Week 8', 'timeFrame': 'At Week 8', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 1: Percentage Of Participants Who Achieved Histologic Improvement at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.\n\nHistologic improvement was defined as decrease from baseline in Geboes score.'}, {'measure': 'Substudy 2: Percentage Of Participants With Endoscopic Improvement at Week 8', 'timeFrame': 'At Week 8', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 2: Percentage Of Participants With Endoscopic Remission at Week 8', 'timeFrame': 'At Week 8', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 2: Percentage Of Participants Achieving Clinical Response Per Adapted Mayo Score at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).'}, {'measure': 'Substudy 2: Percentage Of Participants Achieving Clinical Response Per Partial Mayo Score at Week 2', 'timeFrame': 'At Week 2', 'description': 'The Partial Mayo Score is a composite score of UC disease activity based on the following 2 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n\nThe overall Partial Mayo score ranges from 0 to 6 with higher scores representing more severe disease.\n\nClinical response per Partial Mayo Score is defined as a decrease from Baseline ≥ 1 point and ≥ 30% from Baseline, plus a decrease in RBS ≥ 1 or an absolute RBS ≤ 1.'}, {'measure': 'Substudy 2: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 8', 'timeFrame': 'At Week 8', 'description': 'Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.\n\nThe endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.'}, {'measure': 'Substudy 2: Percentage Of Participants Who Report No Bowel Urgency at Week 8', 'timeFrame': 'At Week 8', 'description': 'Bowel urgency was assessed by participants in a subject diary completed once a day.'}, {'measure': 'Substudy 2: Percentage Of Participants Who Reported No Abdominal Pain at Week 8', 'timeFrame': 'At Week 8', 'description': 'Abdominal pain was assessed by participants in a subject diary completed once a day.'}, {'measure': 'Substudy 2: Percentage Of Participants Who Achieved Histologic Improvement at Week 8', 'timeFrame': 'At Week 8', 'description': 'The Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration. Histologic improvement was defined as decrease from baseline in Geboes score.'}, {'measure': 'Substudy 2: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 8', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.'}, {'measure': 'Substudy 2: Percentage Of Participants With Mucosal Healing at Week 8', 'timeFrame': 'At Week 8', 'description': 'Mucosal healing is defined as an endoscopic score of 0 and Geboes score \\< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.'}, {'measure': 'Substudy 2: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 8', 'timeFrame': 'Baseline (Week 0), Week 8', 'description': 'The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.'}, {'measure': 'Substudy 3: Percentage Of Participants With Endoscopic Improvement at Week 52', 'timeFrame': 'At Week 52', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 3: Percentage of Participants With Clinical Remission Per Adapted Mayo Score at Week 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.'}, {'measure': 'Substudy 3: Percentage of Participants Who Achieved Clinical Remission Per Adapted Mayo Score at Wk 52 and Were Corticosteroid Free for ≥ 90 Days Immediately Preceding Wk 52 Among Those Who Achieved Clinical Remission at the End of the Induction Treatment', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease.\n\nFor Substudy 3, clinical remission is defined as SFS ≤ 1 and not greater than Baseline, RBS of 0, and endoscopic subscore ≤ 1. In addition, evidence of friability during endoscopy in participants with otherwise "mild" endoscopic activity conferred an endoscopic subscore of 2.'}, {'measure': 'Substudy 3: Percentage of Participants With Endoscopic Improvement at Wk 52 Among Those Who Achieved Endoscopic Improvement at the End of the Induction Treatment', 'timeFrame': 'At Week 52', 'description': 'Endoscopic improvement is defined as an endoscopic subscore of 0 or 1. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 3: Percentage Of Participants With Endoscopic Remission At Week 52', 'timeFrame': 'At Week 52', 'description': 'Endoscopic remission is defined as an endoscopic subscore of 0. Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).'}, {'measure': 'Substudy 3: Percentage Of Participants Who Maintained Clinical Response Per Adapted Mayo Score at Wk 52 Among Those Who Achieved Clinical Response at the End of the Induction Treatment', 'timeFrame': 'At Week 52', 'description': 'The Adapted Mayo Score is a composite score of UC disease activity based on the following 3 subscores:\n\n1. Stool frequency subscore (SFS), scored from 0 (normal number of stools) to 3 (5 or more stools more than normal).\n2. Rectal bleeding subscore (RBS), scored from 0 (no blood seen) to 3 (blood alone passed).\n3. Endoscopic subscore, scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).\n\nThe overall Adapted Mayo score ranges from 0 to 9 where higher scores represent more severe disease. Clinical response is defined as a decrease from baseline in the Adapted Mayo score ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 or an absolute RBS ≤ 1).'}, {'measure': 'Substudy 3: Percentage Of Participants Who Achieved Histologic-Endoscopic Mucosal Improvement at Week 52', 'timeFrame': 'At Week 52', 'description': 'Histologic-endoscopic mucosal improvement is defined as an endoscopic subscore of 0 or 1 and a Geboes score ≤ 3.1.\n\nThe endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.'}, {'measure': 'Substudy 3: Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score at Week 52', 'timeFrame': 'Baseline (Week 0), Week 52', 'description': 'The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with ulcerative colitis. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. A positive change from Baseline indicates improvement.'}, {'measure': 'Substudy 3: Percentage Of Participants With Mucosal Healing at Week 52', 'timeFrame': 'At Week 52', 'description': 'Mucosal healing is defined as an endoscopic score of 0 and Geboes score \\< 2.0. The endoscopic subscore ranges from 0 (normal or inactive disease) to 3 (severe disease with spontaneous bleeding, ulceration).\n\nThe Geboes histologic index includes seven histological features (architectural change, chronic inflammatory infiltrate, lamina propria neutrophils and eosinophils, neutrophils in epithelium, crypt destruction and erosion or ulcers). The Geboes score has 6 grades, each with 3-5 subgrades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.'}, {'measure': 'Substudy 3: Percentage Of Participants Who Reported No Bowel Urgency at Week 52', 'timeFrame': 'At Week 52', 'description': 'Bowel urgency was assessed by participants in a subject diary completed once a day.'}, {'measure': 'Substudy 3: Percentage Of Participants Who Reported No Abdominal Pain at Week 52', 'timeFrame': 'At Week 52', 'description': 'Abdominal pain was assessed by participants in a subject diary completed once a day.'}, {'measure': 'Substudy 3: Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Score at Week 52', 'timeFrame': 'Baseline (Week 0), Week 52', 'description': 'The FACIT fatigue questionnaire was developed to assess fatigue associated with anemia. It consists of 13 fatigue-related questions. Each question is answered on a 5-point Likert scale: 0 (not at all); 1 (a little bit); 2 (somewhat); 3 (quite a bit); and 4 (very much). The total score ranges from 0 to 52, where higher scores represent less fatigue, and a positive change from Baseline indicates improvement.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upadacitinib (ABT-494)', 'Moderately to Severely Active UC', 'RINVOQ'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'references': [{'pmid': '40875187', 'type': 'DERIVED', 'citation': 'Burmester GR, Deodhar A, Irvine AD, Panaccione R, Winthrop KL, Vleugels RA, Levy G, Suravaram S, Palac H, Wegrzyn L, Ford S, Meerwein S, Guttman-Yassky E. Safety Profile of Upadacitinib: Descriptive Analysis in Over 27,000 Patient-Years Across Rheumatoid Arthritis, Psoriatic Arthritis, Axial Spondyloarthritis, Atopic Dermatitis, and Inflammatory Bowel Disease. Adv Ther. 2025 Oct;42(10):5215-5237. doi: 10.1007/s12325-025-03328-y. Epub 2025 Aug 28.'}, {'pmid': '40488552', 'type': 'DERIVED', 'citation': 'Panes J, Dubinsky MC, Ishiguro Y, Shukla N, Dubcenco E, Remple V, Sharma D, Panaccione R. Achievement of long-term treatment goals in upadacitinib-treated patients with moderately to severely active ulcerative colitis: a post hoc analysis of phase 3 trial data. J Crohns Colitis. 2025 Jul 3;19(7):jjaf095. doi: 10.1093/ecco-jcc/jjaf095.'}, {'pmid': '38010661', 'type': 'DERIVED', 'citation': 'Panaccione R, Danese S, Zhou W, Klaff J, Ilo D, Yao X, Levy G, Higgins PDR, Loftus EV Jr, Chen S, Gonzalez YS, Leonard C, Hebuterne X, Lindsay JO, Cao Q, Nakase H, Colombel JF, Vermeire S. Efficacy and safety of upadacitinib for 16-week extended induction and 52-week maintenance therapy in patients with moderately to severely active ulcerative colitis. Aliment Pharmacol Ther. 2024 Feb;59(3):393-408. doi: 10.1111/apt.17816. Epub 2023 Nov 27.'}, {'pmid': '37942921', 'type': 'DERIVED', 'citation': 'Raine T, Ishiguro Y, Rubin DT, Finney-Hayward T, Vladea R, Liu J, Phillips C, Cheng E, Targownik L, Loftus EV Jr. Impact of Baseline Corticosteroid Use on the Efficacy and Safety of Upadacitinib in Patients with Ulcerative Colitis: A Post Hoc Analysis of the Phase 3 Clinical Trial Programme. J Crohns Colitis. 2024 May 31;18(5):695-707. doi: 10.1093/ecco-jcc/jjad190.'}, {'pmid': '37683686', 'type': 'DERIVED', 'citation': 'Vermeire S, Danese S, Zhou W, Ilo D, Klaff J, Levy G, Yao X, Chen S, Sanchez Gonzalez Y, Hebuterne X, Lindsay JO, Higgins PDR, Cao Q, Nakase H, Colombel JF, Loftus EV Jr, Panaccione R. Efficacy and safety of upadacitinib maintenance therapy for moderately to severely active ulcerative colitis in patients responding to 8 week induction therapy (U-ACHIEVE Maintenance): overall results from the randomised, placebo-controlled, double-blind, phase 3 maintenance study. Lancet Gastroenterol Hepatol. 2023 Nov;8(11):976-989. doi: 10.1016/S2468-1253(23)00208-X. Epub 2023 Sep 9.'}, {'pmid': '37490069', 'type': 'DERIVED', 'citation': 'Parkes G, Ungaro RC, Danese S, Abreu MT, Arenson E, Zhou W, Ilo D, Laroux FS, Deng H, Sanchez Gonzalez Y, Peyrin-Biroulet L. Correlation of mucosal healing endpoints with long-term clinical and patient-reported outcomes in ulcerative colitis. J Gastroenterol. 2023 Oct;58(10):990-1002. doi: 10.1007/s00535-023-02013-7. Epub 2023 Jul 25.'}, {'pmid': '37296268', 'type': 'DERIVED', 'citation': "Loftus EV Jr, Ananthakrishnan AN, Lee WJ, Gonzalez YS, Fitzgerald KA, Wallace K, Zhou W, Litcher-Kelly L, Ollis SB, Su S, Danese S. Content Validity and Psychometric Evaluation of the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) in Patients with Crohn's Disease and Ulcerative Colitis. Pharmacoecon Open. 2023 Sep;7(5):823-840. doi: 10.1007/s41669-023-00419-w. Epub 2023 Jun 9."}, {'pmid': '36790041', 'type': 'DERIVED', 'citation': "Danese S, Tran J, D'Haens G, Rubin DT, Aoyama N, Zhou W, Ilo D, Yao X, Sanchez Gonzalez Y, Panaccione R. Upadacitinib Induction and Maintenance Therapy Improves Abdominal Pain, Bowel Urgency, and Fatigue in Patients With Ulcerative Colitis: A Post Hoc Analysis of Phase 3 Data. Inflamm Bowel Dis. 2023 Nov 2;29(11):1723-1729. doi: 10.1093/ibd/izad016."}, {'pmid': '36645051', 'type': 'DERIVED', 'citation': 'Panes J, Loftus EV, Higgins PDR, Lindsay JO, Zhou W, Yao X, Ilo D, Phillips C, Tran J, Sanchez Gonzalez Y, Vermeire S. Induction and Maintenance Treatment With Upadacitinib Improves Health-Related Quality of Life in Patients With Moderately to Severely Active Ulcerative Colitis: Phase 3 Study Results. Inflamm Bowel Dis. 2023 Sep 1;29(9):1421-1430. doi: 10.1093/ibd/izac260.'}, {'pmid': '36571701', 'type': 'DERIVED', 'citation': 'Ponce-Bobadilla AV, Stodtmann S, Eckert D, Zhou W, Liu W, Mohamed MF. Upadacitinib Population Pharmacokinetics and Exposure-Response Relationships in Ulcerative Colitis Patients. Clin Pharmacokinet. 2023 Jan;62(1):101-112. doi: 10.1007/s40262-022-01191-6. Epub 2022 Dec 26.'}, {'pmid': '36464141', 'type': 'DERIVED', 'citation': 'Loftus EV Jr, Colombel JF, Takeuchi K, Gao X, Panaccione R, Danese S, Dubinsky M, Schreiber S, Ilo D, Finney-Hayward T, Zhou W, Phillips C, Gonzalez YS, Shu L, Yao X, Zhou Q, Vermeire S. Upadacitinib Therapy Reduces Ulcerative Colitis Symptoms as Early as Day 1 of Induction Treatment. Clin Gastroenterol Hepatol. 2023 Aug;21(9):2347-2358.e6. doi: 10.1016/j.cgh.2022.11.029. Epub 2022 Dec 1.'}, {'pmid': '35644166', 'type': 'DERIVED', 'citation': "Danese S, Vermeire S, Zhou W, Pangan AL, Siffledeen J, Greenbloom S, Hebuterne X, D'Haens G, Nakase H, Panes J, Higgins PDR, Juillerat P, Lindsay JO, Loftus EV Jr, Sandborn WJ, Reinisch W, Chen MH, Sanchez Gonzalez Y, Huang B, Xie W, Liu J, Weinreich MA, Panaccione R. Upadacitinib as induction and maintenance therapy for moderately to severely active ulcerative colitis: results from three phase 3, multicentre, double-blind, randomised trials. Lancet. 2022 Jun 4;399(10341):2113-2128. doi: 10.1016/S0140-6736(22)00581-5. Epub 2022 May 26."}, {'pmid': '32092309', 'type': 'DERIVED', 'citation': "Sandborn WJ, Ghosh S, Panes J, Schreiber S, D'Haens G, Tanida S, Siffledeen J, Enejosa J, Zhou W, Othman AA, Huang B, Higgins PDR. Efficacy of Upadacitinib in a Randomized Trial of Patients With Active Ulcerative Colitis. Gastroenterology. 2020 Jun;158(8):2139-2149.e14. doi: 10.1053/j.gastro.2020.02.030. Epub 2020 Feb 22."}], 'seeAlsoLinks': [{'url': 'https://www.rxabbvie.com', 'label': 'This clinical study may be evaluating a usage that is not currently FDA approved. Please see US Prescribing Information for approved uses.'}]}, 'descriptionModule': {'briefSummary': 'This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction dose of upadacitinib for further evaluation in Substudy 2. The objective of Substudy 2 was to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission in participants. The objective of Substudy 3 was to evaluate the efficacy and safety of upadacitinib compared to placebo in achieving clinical remission in participants who had a response following induction with upadacitinib.', 'detailedDescription': 'Substudy 1 was a Phase 2b dose-ranging study designed to evaluate the efficacy and safety of different oral doses of upadacitinib compared to placebo as 8-week induction therapy in participants with moderately to severely active UC. Approximately 250 participants were planned to be randomized 1:1:1:1:1 to the placebo group and 4 upadacitinib doses (7.5, 15, 30, and 45 mg). Randomization was stratified by previous biologic therapy use (yes/no), Baseline corticosteroid use (yes/no), and Baseline Adapted Mayo score (≤ 7 or \\> 7). The study duration included a Screening Period of up to 5 weeks and an 8-week double-blind (DB) Induction Period. After all randomized participants completed the 8-week induction, a dose-selection analysis of efficacy and safety (selected laboratory parameters) of upadacitinib versus placebo was performed. Based on this dose-selection analysis, one induction dose (upadacitinib 45 mg) was identified for further evaluation in two Phase 3 induction studies, M14-234 Substudy 2 and M14-675 (NCT03653026). During the analysis period, 132 additional participants were randomized into Groups 3 and 4 of Substudy 1 (upadacitinib 30 mg and 45 mg dose groups; approximately 66 participants per dose group). The objectives of enrolling these additional participants were to avoid interrupting the study activities during the analysis period and to support a sufficient number of participants with clinical response to be re-randomized into the maintenance portion in Substudy 3. Substudy 1 main participants are defined as those first 250 randomized 250, and additional participants are defined as those who were randomized after the main participants.\n\nSubstudy 2 was a two-part Phase 3 dose-confirming study designed to evaluate the efficacy and safety of oral administration of upadacitinib 45 mg compared to placebo as induction therapy for up to 16 weeks in participants with moderately to severely active UC. Substudy 2 included a Screening Period of up to 5 weeks, Part 1, and Part 2. Part 1 was a randomized, DB, placebo-controlled 8-week induction period. Part 2 was an open-label, 8-week extended treatment period for clinical non-responders from Part 1 of Substudy 2. Part 1 was planned to enroll 462 subjects; actual enrollment was 474 subjects. Eligible participants were randomized in a 2:1 ratio to one of the two treatment groups (DB upadacitinib 45 mg or matching placebo) for 8 weeks. The randomization was stratified by bio-IR status (Biologic inadequate responders \\[bio-IR\\] vs Non-biologic-inadequate responders \\[non-bio-IR\\], corticosteroid use (yes or no), and Adapted Mayo score (≤ 7 or \\> 7) at Baseline. Within bio-IR, the randomization was further stratified by number of prior biologic treatments (≤ 1 or \\> 1). Within non-bio-IR, the randomization was further stratified by previous biologic use (yes or no). Part 2 was an open label, 8-week Extended Treatment Period for those who did not achieve clinical response per Adapted Mayo score at Week 8 in Part 1. All participants received upadacitinib 45 mg.\n\nSubstudy 3 was a Phase 3 maintenance study designed to evaluate the efficacy and safety of upadacitinib 15 and 30 mg once daily (QD) compared to placebo in achieving clinical remission per Adapted Mayo score in participants with moderately to severely active UC who achieved clinical response per Adapted Mayo score following induction therapy from Substudy 1, Substudy 2, or Study M14-675. A total of 1,046 subjects who achieved clinical response per Adapted Mayo score after completion of induction treatment or Extended Treatment Period in Study M14-234 Substudy 1, Substudy 2, or Study M14-675 entered Substudy 3, and 1,044 were treated with a blinded treatment assignment for up to 52 weeks. Substudy 3 included 4 cohorts. Cohort 1: 847 participants who achieved clinical response in Substudy 1, Substudy 2, or Study M14-675 at either Week 8 or Week 16, and received upadacitinib 15, 30, or 45 mg QD. The treatment groups in Cohort 1 were Group 1: upadacitinib 15 mg QD; Group 2: upadacitinib 30 mg QD; and Group 3: placebo QD. Those who achieved clinical response and received upadacitinib 15 mg QD in Substudy 1 were re-randomized 1:1 to only receive upadacitinib 15 mg QD or placebo QD (treatment Group 1 or 3). Cohort 2: 104 participants who received double-blind placebo QD treatment for 8 weeks during Substudy 1, Substudy 2 Part 1, or Study M14-675 Part 1 and achieved clinical response at Week 8 continued to receive blinded placebo QD in Substudy 3. Cohort 3: 75 participants who received upadacitinib 45 mg QD in Induction Phase and did not achieve clinical response and received upadacitinib 45 mg QD in Extended Treatment in Substudy 2 Part 2 or in Study M14-675 Part 2 and achieved clinical response at Week 16 were re-randomized 1:1 and received blinded upadacitinib 30 mg QD or upadacitinib 15 mg QD in Substudy 3. Cohort 4: 20 participants who received double-blinded treatment of upadacitinib 7.5 mg QD for 8 weeks during Substudy 1 and achieved clinical response at Week 8 continued to receive blinded treatment of upadacitinib 7.5 mg QD in Substudy 3.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\nNote: Adolescent participants who are 16 or 17 years old will be eligible to participate if approved by the country or regulatory/health authority. If approval has not been granted, only participants ≥18 years old will be enrolled. Adolescents must weigh ≥ 40 kilograms and meet the definition of Tanner Stage 5 at Screening Visit.\n\n* Diagnosis of ulcerative colitis for 90 days or greater prior to Baseline, confirmed by colonoscopy during the Screening Period, with exclusion of current infection, colonic dysplasia and/or malignancy. Appropriate documentation of biopsy results consistent with the diagnosis of UC, in the assessment of the Investigator, must be available.\n* Active ulcerative colitis with an Adapted Mayo score of 5 to 9 points and endoscopic sub score of 2 to 3 (confirmed by central reader).\n* Demonstrated an inadequate response to, loss of response to, or intolerance to at least one of the following treatments including: oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapies in the opinion of the investigator.\n\nNote: Participants who have had inadequate response, loss of response to conventional therapy, but have not failed biologic therapy (Non-bio-IR) and have received a prior biologic for up to 1 year may be enrolled, however they must have discontinued the biologic for reasons other than inadequate response or intolerance (e.g., change of insurance, well controlled disease) and must meet criteria for inadequate response, loss of response or intolerance to aminosalicylates, corticosteroids, and/or immunosuppressants as defined above.\n\n* If female, participant must meet the criteria for Contraception Recommendations\n* Female participants of childbearing potential must have a negative serum pregnancy test at the Screening Visit and a negative urine pregnancy test at the Baseline Visit prior to study drug dosing.\n\nExclusion Criteria:\n\n* Participant with current diagnosis of Crohn's disease (CD) or diagnosis of indeterminate colitis (IC)\n* Current diagnosis of fulminant colitis and/or toxic megacolon\n* Participant with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy\n* Received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to Baseline\n* Participant on azathioprine or 6-mercaptopurine within 10 days of Baseline\n* Received intravenous corticosteroids within 14 days prior to Screening or during the Screening Period.\n* Participant with previous exposure to Janus Activated Kinase (JAK) inhibitor (e.g., tofacitinib, baricitinib, filgotinib, upadacitinib).\n* Screening laboratory and other analyses show any abnormal results meeting the exclusion criteria"}, 'identificationModule': {'nctId': 'NCT02819635', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis', 'orgStudyIdInfo': {'id': 'M14-234'}, 'secondaryIdInfos': [{'id': '2016-000641-31', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'SS1: Placebo', 'description': 'During the 8-week induction phase in Substudy 1, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'SS1: Upadacitinib 7.5 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 7.5 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS1: Upadacitinib 15 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 15 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS1: Upadacitinib 30 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 30 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS1: Upadacitinib 45 mg', 'description': 'During the 8-week induction phase in Substudy 1, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Additional participants were enrolled during the Substudy 1 analysis period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 4 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS2: Placebo/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received placebo for upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label extended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS2: Upadacitinib 45 mg/Upadacitinib 45 mg', 'description': 'During the Substudy 2 Part 1 induction period, participants received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for 8 weeks. Participants who did not achieve clinical response at Week 8 of Part 1 were enrolled in an open-label expended treatment period and received 45 mg upadacitinib film-coated tablets once daily by mouth (QD) for an additional 8 weeks.', 'interventionNames': ['Drug: Upadacitinib']}, {'type': 'EXPERIMENTAL', 'label': 'SS3: M14-675 clinical responders', 'description': 'Participants in Study M14-675 (NCT03653026) who achieved clinical response defined by Adapted Mayo Score at Week 8 or Week 16 in that study and did not meet any study discontinuation criteria were eligible to enroll into Substudy 3. Participants were re-randomized and treated with a blinded treatment assignment (15 mg upadacitinib film-coated tablets once daily by mouth \\[QD\\], or 30 mg upadacitinib film-coated tablets QD, or placebo for upadacitinib film-coated tablets QD) for up to 52 weeks.', 'interventionNames': ['Drug: Placebo', 'Drug: Upadacitinib']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'Film-coated tablet for oral administration', 'armGroupLabels': ['SS1: Placebo', 'SS2: Placebo/Upadacitinib 45 mg', 'SS3: M14-675 clinical responders']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'otherNames': ['ABT-494', 'RINVOQ'], 'description': 'Film-coated tablet for oral administration', 'armGroupLabels': ['SS1: Upadacitinib 15 mg', 'SS1: Upadacitinib 30 mg', 'SS1: Upadacitinib 45 mg', 'SS1: Upadacitinib 7.5 mg', 'SS2: Placebo/Upadacitinib 45 mg', 'SS2: Upadacitinib 45 mg/Upadacitinib 45 mg', 'SS3: M14-675 clinical responders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Birmingham Gastroenterology Associates P.C /ID# 151276', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36606', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'East View Medical Research, LLC /ID# 171183', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'CB Flock Research Corporation /ID# 165980', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85224', 'city': 'Chandler', 'state': 'Arizona', 'country': 'United States', 'facility': 'Delsol Research Management, Ll /Id# 170131', 'geoPoint': {'lat': 33.30616, 'lon': -111.84125}}, {'zip': '85206', 'city': 'Mesa', 'state': 'Arizona', 'country': 'United States', 'facility': 'Digestive Disease Consultants, A Division of Arizona Digestive Health, P.C /ID# 211885', 'geoPoint': {'lat': 33.42227, 'lon': -111.82264}}, {'zip': '85306', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Arizona Arthritis & Rheumatology Research, PLLC /ID# 169822', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Adobe Clinical Research LLC /ID# 155250', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'University of Arizona /ID# 150553', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91722-3797', 'city': 'Covina', 'state': 'California', 'country': 'United States', 'facility': 'Citrus Valley Gastroenterology /ID# 151914', 'geoPoint': {'lat': 34.09001, 'lon': -117.89034}}, {'zip': '92648-5994', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Newport Huntington Medical Group /ID# 217005', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UC San Diego Health System /ID# 155185', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90720-3309', 'city': 'Los Alamitos', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Doctors /ID# 207464', 'geoPoint': {'lat': 33.80307, 'lon': -118.07256}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'TLC Clinical Research Inc /ID# 216829', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90067-2001', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Gastrointestinal Biosciences Clinical Trials, LLC /ID# 157080', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '91345', 'city': 'Mission Hills', 'state': 'California', 'country': 'United States', 'facility': 'Facey Medical Foundation /ID# 203133', 'geoPoint': {'lat': 34.68609, 'lon': -120.43683}}, {'zip': '92563', 'city': 'Murrieta', 'state': 'California', 'country': 'United States', 'facility': 'United Medical Doctors - 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This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.', 'accessCriteria': 'Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}