Ignite Creation Date:
2025-12-24 @ 11:16 PM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT02637856
Status:
COMPLETED
Last Update Posted:
2020-05-26
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020529', 'term': 'Multiple Sclerosis, Relapsing-Remitting'}], 'ancestors': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C533411', 'term': 'ocrelizumab'}]}}, '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 up to 100 weeks', 'description': 'The Safety Population included all enrolled participants who received any ocrelizumab.', 'eventGroups': [{'id': 'EG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)', 'otherNumAtRisk': 608, 'deathsNumAtRisk': 608, 'otherNumAffected': 406, 'seriousNumAtRisk': 608, 'deathsNumAffected': 0, 'seriousNumAffected': 47}, {'id': 'EG001', 'title': 'Ocrelizumab (Substudy)', 'description': 'Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)', 'otherNumAtRisk': 129, 'deathsNumAtRisk': 129, 'otherNumAffected': 16, 'seriousNumAtRisk': 129, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 38, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 62, 'numAffected': 58}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 81, 'numAffected': 64}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 47, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 76, 'numAffected': 57}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 118, 'numAffected': 88}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Infusion related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 519, 'numAffected': 263}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 16, 'numAffected': 16}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 41, 'numAffected': 36}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 66, 'numAffected': 56}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'seriousEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Wolff-Parkinson-White syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Mastoid effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Abdominal pain lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': "Crohn's disease", 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Systemic inflammatory response syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Anaphylactic reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Drug hypersensitivity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Gastroenteritis viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Kidney infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Pyelonephritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Ankle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lower limb fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Multiple injuries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Road traffic accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Adenocarcinoma of the cervix', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Lung neoplasm malignant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Multiple sclerosis relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Trigeminal neuralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Suicidal ideation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Suicide attempt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Cardiac ablation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}, {'term': 'Fibromuscular dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 608, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 129, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 22.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '48.1', 'groupId': 'OG000', 'lowerLimit': '43.9', 'upperLimit': '52.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '576', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.0', 'groupId': 'OG000', 'lowerLimit': '54.9', 'upperLimit': '63.1'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '576', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '51.2', 'groupId': 'OG000', 'lowerLimit': '47.0', 'upperLimit': '55.4'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Weeks 24 and 48', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The modified Intent-to-Treat (mITT) population was a subset of the ITT population which excluded participants who discontinued ocrelizumab treatment early without any protocol-defined events for reasons other than death and lack of efficacy. Only participants for whom data were collected are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Time to Protocol-Defined Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because more than 50% of the ITT population were event-free at the end of the study', 'groupId': 'OG000', 'lowerLimit': '53.86', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '0.046', 'groupId': 'OG000', 'lowerLimit': '0.036', 'upperLimit': '0.060'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (\\>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS \\<2.5 vs. \\>=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. \\>1)', 'unitOfMeasure': 'Number of Relapses/Participant Year', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Time to Onset of First Protocol-Defined Relapse', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because more than 50% of the ITT population were event-free at the end of the study', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for \\>24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because more than 50% of the ITT population were event-free at the end of the study', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 96', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because more than 50% of the ITT population were event-free at the end of the study', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 96', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Not estimable because more than 50% of the ITT population were event-free at the end of the study', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Week 96', 'unitOfMeasure': 'Weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'SECONDARY', 'title': 'Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '599', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '33', 'groupId': 'OG000', 'lowerLimit': '0.010', 'upperLimit': '0.050'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '582', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.031'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '557', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000', 'lowerLimit': '0.002', 'upperLimit': '0.026'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, and 96', 'description': 'The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.', 'unitOfMeasure': 'Number of Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '600', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.551', 'spread': '0.590', 'groupId': 'OG000'}]}]}, {'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '595', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.484', 'spread': '0.118', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.549', 'spread': '0.123', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '554', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.560', 'spread': '0.129', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Weeks 24, 48, and 96', 'description': 'Baseline data is represented as mean; post-Baseline date are represented as mean changes.', 'unitOfMeasure': 'cubic centimeter (cm3)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'title': 'Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '640', 'groupId': 'OG000'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '39', 'groupId': 'OG000'}]}]}, {'title': 'Week 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '558', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 24, 48, and 96', 'unitOfMeasure': 'Number of Lesions', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab. Only participants for whom data were collected are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'classes': [{'categories': [{'measurements': [{'value': '86.3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 100 weeks', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled participants who received any ocrelizumab. Participants who prematurely withdrew from the study for any reason and who did not have any assessments for any reason were still included in the ITT population as long as the participant received ocrelizumab'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Ocrelizumab (Substudy)', 'description': 'Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.0', 'upperLimit': '2.8'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 96 to Week 100', 'description': 'Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion', 'unitOfMeasure': 'Percentage of Participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious IRRs throughout the main study'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}, {'id': 'FG001', 'title': 'Ocrelizumab (Substudy)', 'description': 'Participants who completed their Week 72 ocrelizumab infusion and did not experience any serious infusion related reactions (IRRs) throughout the main study were eligible to enroll in an optional substudy and received one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab was administered as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)'}], 'periods': [{'title': 'Main Study (Baseline to Week 100)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '608'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '389'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '219'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Continued on Commercial Ocrevus', 'reasons': [{'groupId': 'FG000', 'numSubjects': '164'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Failed Drug Test', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Incarceration', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Pregnancy Attempts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Site Closing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Sub-Study (Week 72 to Week 100)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '129'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '125'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Non-safety reason (moved out of state)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'The study was conducted in North America at 90 study sites in the U.S. and Canada.', 'preAssignmentDetails': 'Participants with relapsing remitting multiple sclerosis (RRMS) were enrolled, who had had a suboptimal response to an adequate course of a disease-modifying treatment (DMT). An adequate course of prior DMT was defined as the same DMT administered for at least 6 months.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '608', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Ocrelizumab', 'description': 'Participants received ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks)'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.2', 'spread': '8.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '438', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '170', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '526', 'groupId': 'BG000'}]}, {'title': 'Not Stated', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '72', 'groupId': 'BG000'}]}, {'title': 'Multiple', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or other Pacific Islande', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '495', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-19', 'size': 2696095, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-04-15T09:58', 'hasProtocol': True}, {'date': '2019-04-30', 'size': 796844, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-04-15T09:58', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 608}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-02-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-08', 'studyFirstSubmitDate': '2015-12-18', 'resultsFirstSubmitDate': '2020-04-15', 'studyFirstSubmitQcDate': '2015-12-18', 'lastUpdatePostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-05-08', 'studyFirstPostDateStruct': {'date': '2015-12-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-05-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Without Any Protocol-Defined Events During 96-Week Period', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 gadolinium (Gd)-enhanced lesion on brain magnetic resonance imaging (MRI) or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.'}, {'measure': 'Percentage of Participants With Infusion Related Reactions (IRRs) in Optional Substudy', 'timeFrame': 'Week 96 to Week 100', 'description': 'Rate and frequency of Grade 3 or 4 IRRs with onset on or after the shorter ocrelizumab infusion'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Without Any Protocol-Defined Events During 24-Week and 48-Week Period', 'timeFrame': 'Baseline up to Weeks 24 and 48', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.'}, {'measure': 'Time to Protocol-Defined Event', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined event is the occurrence of either protocol-defined relapse (occurrence of new or worsening neurological symptoms attributable to multiple sclerosis) or T1 Gd-enhanced lesion on brain MRI or new and/or enlarging T2 lesion on brain MRI or confirmed disability progression at 24 weeks.'}, {'measure': 'Total Number of Protocol-Defined Relapses Per Participant Year During 96-week Period', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for greater than (\\>) 24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days. The Adjusted Annualized Relapse Rate was adjusted by baseline Expanded Disability Status Scale (EDSS \\<2.5 vs. \\>=2.5) and number of previous disease-modifying treatments (DMTs =1 vs. \\>1)'}, {'measure': 'Time to Onset of First Protocol-Defined Relapse', 'timeFrame': 'Baseline up to Week 96', 'description': 'Protocol-defined relapse is an occurrence of new or worsening neurological symptoms attributable to multiple sclerosis which must persist for \\>24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) and immediately preceded by a stable or improving neurological state for least 30 days.'}, {'measure': 'Time to Onset of First T1 Gd-Enhanced Lesion as Detected by Brain MRI', 'timeFrame': 'Baseline up to Week 96'}, {'measure': 'Time to Onset of First New and/or Enlarging T2 Lesion as Detected by Brain MRI', 'timeFrame': 'Baseline up to Week 96'}, {'measure': 'Time to Onset of Confirmed Disability Progression (CDP) for at Least 24 Weeks According to Expanded Disability Status Scale (EDSS) Score', 'timeFrame': 'Baseline up to Week 96'}, {'measure': 'Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI', 'timeFrame': 'Weeks 24, 48, and 96', 'description': 'The analyses included participants who had an interpretable MRI at the time point of interest. Participants having 0, 1, 2, 3, and greater than 3 lesions at weeks 24, 48, and 96 were included in the analysis.'}, {'measure': 'Change From Baseline in Total T2 Lesion Volume as Detected by Brain MRI', 'timeFrame': 'Baseline, Weeks 24, 48, and 96', 'description': 'Baseline data is represented as mean; post-Baseline date are represented as mean changes.'}, {'measure': 'Total Number of New and/or Enlarging T2 Lesions as Detected by Brain MRI', 'timeFrame': 'Weeks 24, 48, and 96'}, {'measure': 'Percentage of Participants With Adverse Events', 'timeFrame': 'Baseline up to 100 weeks', 'description': 'An adverse event is any untoward medical occurrence in a subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.'}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis, Relapsing-Remitting']}, 'descriptionModule': {'briefSummary': 'This study will evaluate the efficacy and safety of ocrelizumab in participants with RRMS who have had a suboptimal response to an adequate course of DMT. Participants will receive ocrelizumab as an initial dose of two 300-milligrams (mg) intravenous (IV) infusions (600 mg total) separated by 14 days followed by one 600-mg IV infusion for a maximum of 4 doses (up to 96 weeks). Anticipated time on study treatment is 96 weeks.', 'detailedDescription': 'Participants who complete their Week 72 ocrelizumab infusion and do not experience any serious infusion related reaction (IRR) throughout the main study will be eligible to enroll in an optional, open-label, non-randomized substudy to MN30035 and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. This substudy will enroll approximately 100 patients from MN30035 main study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of multiple sclerosis (specifically RRMS), in accordance with the revised 2010 McDonald criteria\n* Disease duration from first symptom of less than or equal to (\\</=) 12 years\n* Treated with an adequate course of treatment with no more than three prior DMT regimens of greater than or equal to (\\>/=) 6 months, and the discontinuation of the most recent adequately used DMT was due to suboptimal response\n* Suboptimal response while the participant was on his/her last adequately used DMT for \\>/=6 months (defined by having one of the following qualifying events despite being on a stable dose of the same DMT for at least 6 months: one or more clinically reported relapses, one or more T1 Gd-enhanced lesions, or two or more new or enlarging T2 lesions on MRI); these qualifying events must have occurred while on the last adequately used DMT. In participants receiving stable doses of the same approved DMT for more than a year, the event must have occurred within the last 12 months of treatment with this DMT from the date of screening\n\nExclusion Criteria:\n\n* History of primary progressive multiple sclerosis (PPMS), progressive relapsing multiple sclerosis (PRMS), or secondary progressive multiple sclerosis (SPMS)\n* Contraindications for MRI\n* Known presence of other neurological disorders that may mimic multiple sclerosis\n* Pregnancy or lactation, or intention to become pregnant during the study\n* Requirement for chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* History of or currently active primary or secondary immunodeficiency\n* Lack of peripheral venous access\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n* Active infection, or history of or known presence of recurrent or chronic infection such as human immunodeficiency virus (HIV), syphilis, or tuberculosis\n* History of progressive multifocal leukoencephalopathy\n* Contraindications to or intolerance of oral or IV corticosteroids\n* Previous treatment with fingolimod (Gilenya®) or dimethyl fumarate (Tecfidera®) in participants whose lymphocyte count is below the lower limit of normal (LLN)\n* Treatment with alemtuzumab (Lemtrada®)\n* Previous treatment with systemic cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, or methotrexate\n* Previous treatment with natalizumab within 12 months prior to screening unless failure was due to confirmed, persistent anti-drug antibodies (ADAs). Participants previously treated with natalizumab will be eligible for this study only if duration of treatment with natalizumab was less than (\\<) 1 year and natalizumab was not used in the 12 months prior to screening. Anti-John Cunningham virus (JCV) antibody status (positive or negative) and titer (both assessed within the year of screening) must be documented prior to enrollment\n* Treatment with dalfampridine (Ampyra®) unless on stable dose for \\>/=30 days prior to screening\n* Treatment with a B-cell targeted therapies (e.g., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)\n* Treatment with a drug that is experimental (Exception: treatment with an experimental drug that was subsequently approved in the participant's country is allowed)"}, 'identificationModule': {'nctId': 'NCT02637856', 'briefTitle': 'A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': 'An Open-Label Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Relapsing Remitting Multiple Sclerosis Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment', 'orgStudyIdInfo': {'id': 'MN30035'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab', 'description': 'Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).', 'interventionNames': ['Drug: Ocrelizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ocrelizumab (substudy)', 'description': 'Participants with no serious IRR throughout the main study will be eligible to enroll in an optional substudy and receive one additional shorter infusion of ocrelizumab at the Week 96 visit. Ocrelizumab will be administered IV as a single 600-mg dose at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)', 'interventionNames': ['Drug: Ocrelizumab']}], 'interventions': [{'name': 'Ocrelizumab', 'type': 'DRUG', 'otherNames': ['RO4964913'], 'description': 'Participants will receive ocrelizumab as an initial dose of two 300-mg IV infusions (600 mg total) separated by 14 days (on Days 1 and 15) followed by one 600-mg IV infusion every 24 weeks for a maximum of 4 doses (up to 96 weeks).', 'armGroupLabels': ['Ocrelizumab']}, {'name': 'Ocrelizumab', 'type': 'DRUG', 'otherNames': ['RO4964913'], 'description': 'Participants will receive an additional single 600-mg dose IV infusion at a shorter infusion rate (approximately 2 hours instead of 3.5 hours)', 'armGroupLabels': ['Ocrelizumab (substudy)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35058', 'city': 'Cullman', 'state': 'Alabama', 'country': 'United States', 'facility': 'North Central Neurology Associates', 'geoPoint': {'lat': 34.17482, 'lon': -86.84361}}, {'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Phoenix Neurological Associates Ltd', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85013', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Barrow Neurological Institute', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Territory Neurology and Research Institute', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92011', 'city': 'Carlsbad', 'state': 'California', 'country': 'United States', 'facility': 'The Research Center of Southern California, LLC', 'geoPoint': {'lat': 33.15809, 'lon': -117.35059}}, {'zip': '95608', 'city': 'Carmichael', 'state': 'California', 'country': 'United States', 'facility': 'Mercy Medical Group; 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