Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-02-22 @ 9:38 AM
Study NCT ID:
NCT02136069
Status:
COMPLETED
Last Update Posted:
2021-12-03
First Post:
2014-04-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Philippines', 'Vietnam']}, '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': 'C559198', 'term': 'etrolizumab'}, {'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D007267', 'term': 'Injections'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'genentech@druginfo.com', 'phone': '800 821-8590', 'title': 'Medical Communications', 'organization': 'Hoffmann-La Roche'}, 'certainAgreement': {'otherDetails': "The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.', 'otherNumAtRisk': 199, 'deathsNumAtRisk': 199, 'otherNumAffected': 94, 'seriousNumAtRisk': 199, 'deathsNumAffected': 0, 'seriousNumAffected': 32}, {'id': 'EG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.', 'otherNumAtRisk': 198, 'deathsNumAtRisk': 198, 'otherNumAffected': 80, 'seriousNumAtRisk': 198, 'deathsNumAffected': 1, 'seriousNumAffected': 20}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 47, 'numAffected': 45}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 36, 'numAffected': 33}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 12, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 30, 'numAffected': 23}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 24, 'numAffected': 21}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 30, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 28, 'numAffected': 19}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Retinal vein occlusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Colitis ulcerative', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Incarcerated umbilical hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pancreatitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Anal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Bacteraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Cytomegalovirus colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Lower respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Meningitis listeria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Orchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Stitch abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Incisional hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Procedural intestinal perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Tendon rupture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Thoracic vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': "Hodgkin's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Neuroendocrine tumour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Central nervous system vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Haematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Renal colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pulmonary embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}, {'term': 'Pyoderma gangrenosum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 199, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 198, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.6', 'groupId': 'OG000'}, {'value': '19.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8114', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciPctValue': '95', 'paramValue': '-0.9', 'ciLowerLimit': '-8.70', 'ciUpperLimit': '6.83', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10, Week 54', 'description': "Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.6', 'groupId': 'OG000'}, {'value': '32.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1293', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.0', 'ciLowerLimit': '-20.50', 'ciUpperLimit': '-3.26', 'pValueComment': 'p-values are not multiplicity adjusted', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'NON_INFERIORITY', 'statisticalComment': 'A Farrington-Manning non-inferiority test was used to determine the nominal p-value.', 'nonInferiorityComment': 'with margin -12.5%'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '20.1', 'groupId': 'OG000'}, {'value': '23.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4056', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.4', 'ciLowerLimit': '-11.53', 'ciUpperLimit': '4.74', 'pValueComment': 'p-values are not multiplicity adjusted', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 54', 'description': "Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.6', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4591', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.4', 'ciLowerLimit': '-8.88', 'ciUpperLimit': '4.14', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10 and Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '98', 'groupId': 'OG000'}, {'value': '117', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.8', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4196', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-7.54', 'ciUpperLimit': '18.13', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10 and Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that achieved a Clinical Response at Week 10'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.7', 'groupId': 'OG000'}, {'value': '49.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0118', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-12.4', 'ciLowerLimit': '-21.84', 'ciUpperLimit': '-2.66', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.1', 'groupId': 'OG000'}, {'value': '32.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2845', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-4.9', 'ciLowerLimit': '-13.76', 'ciUpperLimit': '4.12', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.1', 'groupId': 'OG000'}, {'value': '24.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1234', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.3', 'ciLowerLimit': '-14.30', 'ciUpperLimit': '1.84', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 10, Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '17.6', 'groupId': 'OG000'}, {'value': '22.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2168', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.0', 'ciLowerLimit': '-12.84', 'ciUpperLimit': '2.94', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nEndoscopic Remission is Endoscopy subscore = 0.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'groupId': 'OG000'}, {'value': '59.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0564', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-9.5', 'ciLowerLimit': '-19.06', 'ciUpperLimit': '0.29', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '23.1', 'groupId': 'OG000'}, {'value': '29.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1729', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Response Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.0', 'ciLowerLimit': '-14.51', 'ciUpperLimit': '2.70', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 10, Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants That Achieve Clinical Remission Corticosteroid-Free at Week 54 (Off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.5', 'groupId': 'OG000'}, {'value': '17.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8941', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Difference in Remission Rates', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.8', 'ciLowerLimit': '-12.01', 'ciUpperLimit': '10.68', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.", 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that were receiving corticosteroids at baseline'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '42', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '72', 'groupId': 'OG000'}, {'value': '74', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events Leading to Study Drug Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All AEs were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Infection-Related Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Malignancies', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'OG000'}, {'value': '198', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'title': 'Grade 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Grade 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Grade 4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Grade 5', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Pharmacokinetics: Etrolizumab Serum Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}], 'classes': [{'title': 'Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.64', 'spread': '2.75', 'groupId': 'OG000'}]}]}, {'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '4.63', 'groupId': 'OG000'}]}]}, {'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.92', 'spread': '3.18', 'groupId': 'OG000'}]}]}, {'title': 'Week 32', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '5.96', 'groupId': 'OG000'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.2', 'spread': '5.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 2, 10, 12, 30, and 54', 'unitOfMeasure': 'microgram/milliliter', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of etrolizumab-treated participants who received at least one dose of study drug and had at least one quantifiable concentration measured post baseline.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'OG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'classes': [{'title': 'Week 10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '43.2', 'spread': '36.6', 'groupId': 'OG000'}, {'value': '45.1', 'spread': '39.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '102', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '53.5', 'spread': '40.8', 'groupId': 'OG000'}, {'value': '59.6', 'spread': '34.4', 'groupId': 'OG001'}]}]}, {'title': 'Week 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '58.2', 'spread': '32.9', 'groupId': 'OG000'}, {'value': '63.2', 'spread': '38.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4106', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.1', 'ciLowerLimit': '-10.6', 'ciUpperLimit': '4.3', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Week 10'}, {'pValue': '0.1434', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-5.7', 'ciLowerLimit': '-13.3', 'ciUpperLimit': '1.9', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Week 30'}, {'pValue': '0.1103', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference in Adjusted Means', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-6.1', 'ciLowerLimit': '-13.6', 'ciUpperLimit': '1.4', 'pValueComment': 'p-value has not been adjusted for multiplicity', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'Week 54'}], 'paramType': 'MEAN', 'timeFrame': 'Weeks 10, 30, and 54', 'description': "The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL.\n\nIBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants that completed the IBDQ Questionnaire at baseline and at the respective Time Points'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab', 'denoms': [{'units': 'Participants', 'counts': [{'value': '196', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}], 'classes': [{'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 4, 10, 12, 30, and 54', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of etrolizumab-treated participants with at least one baseline or post-baseline ATA result from at least one sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'FG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '199'}, {'groupId': 'FG001', 'numSubjects': '198'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '165'}, {'groupId': 'FG001', 'numSubjects': '170'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'UC flare-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Non-Compliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.'}, {'id': 'BG001', 'title': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40.0', 'spread': '15.2', 'groupId': 'BG000'}, {'value': '39.5', 'spread': '13.4', 'groupId': 'BG001'}, {'value': '39.8', 'spread': '14.3', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '81', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '147', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '250', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '150', 'groupId': 'BG000'}, {'value': '158', 'groupId': 'BG001'}, {'value': '308', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mayo Clinic Score (MCS) ≤9 or ≥10 at Baseline', 'classes': [{'title': 'MCS ≤9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '139', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '286', 'groupId': 'BG002'}]}]}, {'title': 'MCS ≥10', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '396', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '50', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "Measure Description: Participants were stratified by concomitant treatment with corticosteroids (yes/no) at randomization, concomitant treatment with immunosuppressants (yes/no) at randomization, and disease activity measured during screening (MCS ≤9/MCS ≥10). The MCS ranges from 0 to 12 and is a composite of the four following assessments of disease activity: stool frequency subscore, rectal bleeding subscore, endoscopy subscore, and physician's global assessment (PGA) subscore. Each of the four assessments was rated with a score from 0 to 3, with higher scores indicating more severe disease.", 'unitOfMeasure': 'Participants', 'populationDescription': 'For the Infliximab arm, only 197 subjects had MCS categorical scores available for baseline.'}, {'title': 'Baseline Treatment: None, Corticosteroids (CS) or Immunosuppressants (IS) Alone, or Both CS and IS', 'classes': [{'title': 'Corticosteroids (CS) Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '59', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '115', 'groupId': 'BG002'}]}]}, {'title': 'Immunosuppressants (IS) Alone', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}]}, {'title': 'Both CS and IS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}]}]}, {'title': 'None', 'denoms': [{'units': 'Participants', 'counts': [{'value': '199', 'groupId': 'BG000'}, {'value': '198', 'groupId': 'BG001'}, {'value': '397', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '75', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Participants were stratified by concomitant treatment with corticosteroids (yes/no) at randomization, concomitant treatment with immunosuppressants (yes/no) at randomization, and disease activity measured during screening (MCS ≤9/MCS ≥10).', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-10-22', 'size': 3503557, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-06-18T10:36', 'hasProtocol': True}, {'date': '2020-05-04', 'size': 1330359, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-06-18T10:36', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 397}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-12-01', 'studyFirstSubmitDate': '2014-04-15', 'resultsFirstSubmitDate': '2021-06-18', 'studyFirstSubmitQcDate': '2014-05-08', 'lastUpdatePostDateStruct': {'date': '2021-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-21', 'studyFirstPostDateStruct': {'date': '2014-05-12', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Both Clinical Response at Week 10 and Clinical Remission at Week 54, as Determined by the Mayo Clinic Score (MCS)', 'timeFrame': 'Week 10, Week 54', 'description': "Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1."}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving Clinical Remission at Week 10, Defined as MCS ≤2 With Individual Subscores ≤1', 'timeFrame': 'Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease."}, {'measure': 'Percentage of Participants Achieving Clinical Remission at Week 54, as Determined by the MCS', 'timeFrame': 'Week 54', 'description': "Mayo Clinic Score (MCS) is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1."}, {'measure': 'Percentage of Participants Achieving Clinical Remission at Both Week 10 and Week 54, as Determined by the MCS', 'timeFrame': 'Week 10 and Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1."}, {'measure': 'Percentage of Participants Achieving Clinical Remission at Week 54 Among Those With a Clinical Response at Week 10, as Determined by the MCS', 'timeFrame': 'Week 10 and Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1."}, {'measure': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 10, Determined by the MCS', 'timeFrame': 'Baseline to Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1."}, {'measure': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Week 54, as Determined by the MCS', 'timeFrame': 'Baseline to Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1."}, {'measure': 'Percentage of Participants With Improvement in Endoscopic Appearance of the Mucosa at Both Week 10 and Week 54, as Determined by the MCS', 'timeFrame': 'Baseline to Week 10, Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nImprovement in endoscopic appearance of the mucosa is Endoscopy subscore ≤1."}, {'measure': 'Percentage of Participants With Endoscopic Remission at Week 54, as Determined by the MCS', 'timeFrame': 'Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nEndoscopic Remission is Endoscopy subscore = 0."}, {'measure': 'Percentage of Participants Achieving Clinical Response at Week 10, as Determined by the MCS', 'timeFrame': 'Week 10', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1."}, {'measure': 'Percentage of Participants Achieving Clinical Response at Both Weeks 10 and 54, as Determined by the MCS', 'timeFrame': 'Week 10, Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Response is MCS with ≥3-point decrease and 30% reduction from baseline as well as ≥1-point decrease in rectal bleeding subscore or an absolute rectal bleeding score of 0 or 1."}, {'measure': 'Percentage of Participants That Achieve Clinical Remission Corticosteroid-Free at Week 54 (Off Corticosteroid for at Least 24 Weeks Prior to Week 54) Among Those Who Were Receiving Corticosteroids at Baseline, as Determined by the MCS', 'timeFrame': 'Week 54', 'description': "MCS is a composite of 4 assessments, each rated from 0-3: stool frequency, rectal bleeding, endoscopy, and physician's global assessment. Higher scores indicate more severe disease.\n\nClinical Remission is MCS ≤2 with individual subscores ≤1."}, {'measure': 'Number of Participants With Adverse Events, Severity Determined According to the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE v4.0)', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.'}, {'measure': 'Number of Participants With Adverse Events Leading to Study Drug Discontinuation', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)'}, {'measure': 'Number of Participants With Infection-Related Adverse Events, Severity Determined According to the NCI CTCAE v4.0', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All AEs were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.'}, {'measure': 'Number of Participants With Serious Infection-Related Adverse Events', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)'}, {'measure': 'Number of Participants With Malignancies', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)'}, {'measure': 'Number of Participants With Injection-Site Reactions, Severity Determined According to the NCI CTCAE v4.0', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.'}, {'measure': 'Number of Participants With Hypersensitivity Reaction Events, Severity Determined According to the NCI CTCAE v4.0', 'timeFrame': 'Baseline until the end of study (up to 66 weeks)', 'description': 'All adverse events (AEs) were graded for severity using the NCI-CTCAE v4.0. Any AE not specifically listed was assessed per the following 5 grades: Grade 1 = mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; or intervention not indicated. Grade 2 = moderate; minimal, local, or non-invasive intervention indicated; or limiting age-appropriate instrumental activities of daily living. Grade 3 = severe or medically significant, but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; or limiting self-care activities of daily living. Grade 4 = life-threatening consequences or urgent intervention indicated. Grade 5 = death related to AE. Not all grades are appropriate for all AEs; some AEs have fewer than 5 options. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Multiple occurrences of AEs were counted only once per participant at the highest (worst) grade.'}, {'measure': 'Pharmacokinetics: Etrolizumab Serum Concentration', 'timeFrame': 'Weeks 2, 10, 12, 30, and 54'}, {'measure': 'Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Overall Score at Weeks 10, 30, and 54', 'timeFrame': 'Weeks 10, 30, and 54', 'description': "The IBDQ is used to assess participant's health-related quality of life (QOL). The 32-item questionnaire contains four domains: bowel symptoms (10 items), systemic symptoms (5 items), emotional function (12 items), and social function (5 items). The items are scored on a 7-point Likert scale with a higher score indicating better health-related QOL.\n\nIBDQ score is a total score summed up from across all 32 questions on the questionnaire. The score can range from 32-224 and the higher score indicates a better quality of life."}, {'measure': 'Number of Participants With Anti-Therapeutic Antibodies (ATAs) to Etrolizumab', 'timeFrame': 'Weeks 0, 4, 10, 12, 30, and 54'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '34798038', 'type': 'DERIVED', 'citation': "Danese S, Colombel JF, Lukas M, Gisbert JP, D'Haens G, Hayee B, Panaccione R, Kim HS, Reinisch W, Tyrrell H, Oh YS, Tole S, Chai A, Chamberlain-James K, Tang MT, Schreiber S; GARDENIA Study Group. Etrolizumab versus infliximab for the treatment of moderately to severely active ulcerative colitis (GARDENIA): a randomised, double-blind, double-dummy, phase 3 study. Lancet Gastroenterol Hepatol. 2022 Feb;7(2):118-127. doi: 10.1016/S2468-1253(21)00294-6. Epub 2021 Nov 17."}, {'pmid': '32445184', 'type': 'DERIVED', 'citation': "Sandborn WJ, Vermeire S, Tyrrell H, Hassanali A, Lacey S, Tole S, Tatro AR; Etrolizumab Global Steering Committee. Etrolizumab for the Treatment of Ulcerative Colitis and Crohn's Disease: An Overview of the Phase 3 Clinical Program. Adv Ther. 2020 Jul;37(7):3417-3431. doi: 10.1007/s12325-020-01366-2. Epub 2020 May 22."}]}, 'descriptionModule': {'briefSummary': 'This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to severe ulcerative colitis (UC) who are naive to tumor necrosis factor (TNF) inhibitors. Participants will be randomized in a 1:1 ratio to receive either etrolizumab 105 milligrams (mg) by subcutaneous (SC) injection once every 4 weeks (Q4W) + placebo (intravenous \\[IV\\] infusion at Weeks 0, 2, and 6, then once every 8 weeks \\[Q8W\\]) or infliximab 5 milligrams/kilogram (mg/kg) IV at Weeks 0, 2, and 6, then Q8W) + placebo (SC Q4W). Time on treatment is 54 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Moderately to severely active UC as determined by the Mayo Clinic Score assessment (MCS)\n* Naive to treatment with any anti-TNF inhibitor therapy (including TNF inhibitor biosimilars)\n* An inadequate response to or intolerance of prior corticosteroid and/or immunosuppressant treatment\n* Background regimen for UC may include oral 5-aminosalicylate (5-ASA), oral corticosteroids, budenoside multi-matrix system (MMX), probiotics, azathioprine (AZA), 6-mercaptopurine (6-MP), or methotrexate (MTX) if doses have been stable during the screening period\n* Use of highly effective contraception during and at least 24 weeks after the last dose of study drug\n\nExclusion Criteria:\n\n* A history of or current conditions and diseases affecting the digestive tract, such as indeterminate colitis, suspicion of ischemic, radiation or microscopic colitis, Crohn's disease, fistulas or abdominal abscesses, colonic mucosal dysplasia, intestinal obstruction, toxic megacolon, or unremoved adenomatous colonic polyps\n* Prior or planned surgery for UC\n* Past or present ileostomy or colostomy\n* Have received non-permitted inflammatory bowel disease (IBD) therapies (including natalizumab, vedolizumab, efalizumab, and tofactinib)\n* History of moderate or severe allergic or anaphylactic/anaphylactoid reactions to chimeric, human, or humanized antibodies; fusion proteins, or murine proteins; hypersensitivity to etrolizumab or any of its excipients\n* Chronic hepatitis B or C infection, Human deficiency virus (HIV) or tuberculosis (active or latent)"}, 'identificationModule': {'nctId': 'NCT02136069', 'acronym': 'GARDENIA', 'briefTitle': 'A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'Phase III, Randomized, Multicenter Double-Blind, Double Dummy Study to Evaluate the Efficacy and Safety of Etrolizumab Compared With Infliximab in Patients With Moderate to Severe Active Ulcerative Colitis Who Are Naive to TNF Inhibitors', 'orgStudyIdInfo': {'id': 'GA29103'}, 'secondaryIdInfos': [{'id': '2013-004282-14', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Etrolizumab + Placebo (IV)', 'description': 'Participants will receive ertolizumab (SC) Q4W until Week 52 along with placebo matched to infliximab as IV infusion until Week 46.', 'interventionNames': ['Drug: Etrolizumab', 'Other: Placebo (IV)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab + Placebo (Injection)', 'description': 'Participants will receive IV infusion of infliximab at Weeks 0,2, and 6, then every 8 weeks until Week 46 partnered with placebo matched to etrolizumab by SC injection Q4W until Week 52.', 'interventionNames': ['Drug: Infliximab', 'Other: Placebo (Injection)']}], 'interventions': [{'name': 'Etrolizumab', 'type': 'DRUG', 'otherNames': ['PRO145223', 'RO5490261', 'RG7413'], 'description': '105 mg administered by subcutaneous (SC) injection once every 4 weeks (Q4W) until Week 52.', 'armGroupLabels': ['Etrolizumab + Placebo (IV)']}, {'name': 'Infliximab', 'type': 'DRUG', 'description': '5 mg/kg of infliximab will be administered by intravenous (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.', 'armGroupLabels': ['Infliximab + Placebo (Injection)']}, {'name': 'Placebo (IV)', 'type': 'OTHER', 'description': 'Administered by (IV) infusion at Weeks 0, 2, and 6 and then every 8 weeks until Week 46.', 'armGroupLabels': ['Etrolizumab + Placebo (IV)']}, {'name': 'Placebo (Injection)', 'type': 'OTHER', 'description': 'Administered by SC injection Q4W until Week 52', 'armGroupLabels': ['Infliximab + Placebo (Injection)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5020', 'city': 'Salzburg', 'country': 'Austria', 'facility': 'LKH - Universitätsklinikum der PMU Salzburg', 'geoPoint': {'lat': 47.79941, 'lon': 13.04399}}, {'zip': '2018', 'city': 'Antwerp', 'country': 'Belgium', 'facility': 'GZA Ziekenhuizen - Campus Sint-Vincentius', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imeldaziekenhuis', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '1000', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'CHU St Pierre (St Pierre)', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1090', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Universitair Ziekenhuis Brussel; Neurology', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '1200', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Cliniques Universitaires Saint-Luc; Pharmacy', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '2200', 'city': 'Herentals', 'country': 'Belgium', 'facility': 'AZ Sint Elisabeth Herentals', 'geoPoint': {'lat': 51.17655, 'lon': 4.83248}}, {'zip': 'T2N 4Z6', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Calgary; Heritage Medical Research Clinic', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'T6G 2X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Zeidler Ledcor Centre - University of Alberta; Division of Gasroenterology', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'N1H 3R3', 'city': 'Guelph', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Guelph GI & Surgery Clinic', 'geoPoint': {'lat': 43.54594, 'lon': -80.25599}}, {'zip': 'J4V 2H1', 'city': 'Greenfield Park', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Centre de santé et de services sociaux Champlain-Charles-Le Moyne', 'geoPoint': {'lat': 45.48649, 'lon': -73.46223}}, {'zip': 'H1T 2M4', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Hôpital Maisonneuve - Rosemont', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}, {'zip': 'S7N 0W8', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Royal University Hospital', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}, {'zip': '636 00', 'city': 'Brno', 'country': 'Czechia', 'facility': 'Vojenska nemocnice Brno', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'facility': 'Fakultni nemocnice Hradec Kralove', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '272 59', 'city': 'Kladno', 'country': 'Czechia', 'facility': 'Oblastni nemocnice Kladno, a.s., nemocnice Stredoces. kraje; Endoskopicke centrum', 'geoPoint': {'lat': 50.14734, 'lon': 14.10285}}, {'zip': '728 80', 'city': 'Ostrava', 'country': 'Czechia', 'facility': 'Mestska Nemocnice Ostrava', 'geoPoint': {'lat': 49.83465, 'lon': 18.28204}}, {'zip': '532 03', 'city': 'Pardubice', 'country': 'Czechia', 'facility': 'Pardubicka krajska nemocnice, a.s.', 'geoPoint': {'lat': 50.04075, 'lon': 15.77659}}, {'zip': '170 04', 'city': 'Prague', 'country': 'Czechia', 'facility': 'ISCARE a.s.', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '401 13', 'city': 'Ústí nad Labem', 'country': 'Czechia', 'facility': 'Krajska zdravotni, a.s. - Masarykova nemocnice v Usti nad Labem, o.z., Ocni oddeleni', 'geoPoint': {'lat': 50.6607, 'lon': 14.03227}}, {'zip': '76001', 'city': 'Zlín', 'country': 'Czechia', 'facility': 'Krajska nemocnice T. Bati, a.s.', 'geoPoint': {'lat': 49.22645, 'lon': 17.67065}}, {'zip': '14033', 'city': 'Caen', 'country': 'France', 'facility': 'CHU de Caen - Hopital Cote de Nacre', 'geoPoint': {'lat': 49.18585, 'lon': -0.35912}}, {'zip': '37170', 'city': 'Chambray-lès-Tours', 'country': 'France', 'facility': 'CHU Tours - Hôpital Trousseau', 'geoPoint': {'lat': 47.33537, 'lon': 0.70286}}, {'zip': '63000', 'city': 'Clermont-Ferrand', 'country': 'France', 'facility': 'CHU Clermont Ferrand - Hôtel Dieu', 'geoPoint': {'lat': 45.77969, 'lon': 3.08682}}, {'zip': '92110', 'city': 'Clichy', 'country': 'France', 'facility': 'Hôpital Beaujon', 'geoPoint': {'lat': 48.90018, 'lon': 2.30952}}, {'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'CHU Hopital Saint Eloi', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'zip': '06202', 'city': 'Nice', 'country': 'France', 'facility': "CHU Nice - Hopital de l'Archet 2", 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}, {'zip': '69495', 'city': 'Pierre-Bénite', 'country': 'France', 'facility': 'Centre Hospitalier Lyon Sud; Service de Gastro-Enterologie', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'zip': '54511', 'city': 'Vandœuvre-lès-Nancy', 'country': 'France', 'facility': 'Hôpital de Brabois Adultes', 'geoPoint': {'lat': 48.66115, 'lon': 6.17114}}, {'zip': '12200', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14050', 'city': 'Berlin', 'country': 'Germany', 'facility': 'DRK Kliniken Berlin Westend', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14163', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Krankenhaus Waldfriede e. 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