Viewing Study NCT01405820

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Ignite Creation Date: 2025-12-25 @ 4:19 AM
Ignite Modification Date: 2026-02-07 @ 7:24 PM
Study NCT ID: NCT01405820
Status: COMPLETED
Last Update Posted: 2015-08-21
First Post: 2011-07-14
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

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': 'D000069442', 'term': 'Natalizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'title': 'Biogen Study Medical Director', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were analyzed during the randomized and open-label (OL) periods separately. Randomized period: AEs, after 1st randomized dose on Day 0 and prior to OL infusion of natalizumab at Week 60 (±5 days); SAEs also between Screening and dosing on Day 0.', 'description': 'OL period: on or after OL infusion of natalizumab at Week 60 through to Week 72 (±2 weeks). If participant did not receive natalizumab infusions during the OL period (Week 60 to Week 72), all events with an onset date after Day 0 were considered as occurring during the randomized treatment period. AE data is presented for the Safety Population.', 'eventGroups': [{'id': 'EG000', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks.', 'otherNumAtRisk': 54, 'otherNumAffected': 40, 'seriousNumAtRisk': 54, 'seriousNumAffected': 7}, {'id': 'EG001', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks.', 'otherNumAtRisk': 45, 'otherNumAffected': 31, 'seriousNumAtRisk': 45, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.', 'otherNumAtRisk': 52, 'otherNumAffected': 31, 'seriousNumAtRisk': 52, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.', 'otherNumAtRisk': 53, 'otherNumAffected': 34, 'seriousNumAtRisk': 53, 'seriousNumAffected': 3}, {'id': 'EG004', 'title': 'Randomized Period: Natalizumab 150 mg IV Every 12 Weeks', 'description': 'Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.', 'otherNumAtRisk': 47, 'otherNumAffected': 31, 'seriousNumAtRisk': 47, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'Randomized Period: Natalizumab 150 mg SC Every 12 Weeks', 'description': 'Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.', 'otherNumAtRisk': 38, 'otherNumAffected': 17, 'seriousNumAtRisk': 38, 'seriousNumAffected': 1}, {'id': 'EG006', 'title': 'Open-label Period: Natalizumab 300 mg IV Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 44, 'otherNumAffected': 2, 'seriousNumAtRisk': 44, 'seriousNumAffected': 0}, {'id': 'EG007', 'title': 'Open-label Period: Natalizumab 300 mg SC Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 35, 'otherNumAffected': 4, 'seriousNumAtRisk': 35, 'seriousNumAffected': 1}, {'id': 'EG008', 'title': 'Open-label Period: Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 42, 'otherNumAffected': 2, 'seriousNumAtRisk': 42, 'seriousNumAffected': 0}, {'id': 'EG009', 'title': 'Open-label Period: Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 42, 'otherNumAffected': 0, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG010', 'title': 'Open-label Period: Natalizumab 150 mg IV Every 12 Weeks', 'description': 'Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 42, 'otherNumAffected': 4, 'seriousNumAtRisk': 42, 'seriousNumAffected': 1}, {'id': 'EG011', 'title': 'Open-label Period: Natalizumab 150 mg SC Every 12 Weeks', 'description': 'Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'otherNumAtRisk': 32, 'otherNumAffected': 6, 'seriousNumAtRisk': 32, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 17.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 8}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Pharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oral Herpes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Multiple Sclerosis Relapse', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 13}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 17}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 3}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 4}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sciatica', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cerebrovascular Insufficiency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Coma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Polyneuropathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Intervertebral Disc Protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Automatic Bladder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary Retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nuclear Magnetic Resonance Imaging Abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Radius Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 54, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 52, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 38, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 44, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG010', 'numAtRisk': 42, 'numAffected': 0}, {'groupId': 'EG011', 'numAtRisk': 32, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Cumulative Number of Combined Unique Active Lesions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '45', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '35', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks.'}, {'id': 'OG001', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks.'}, {'id': 'OG002', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.'}, {'id': 'OG003', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.'}, {'id': 'OG004', 'title': 'Randomized Period: Natalizumab 150 mg IV Every 12 Weeks', 'description': 'Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.'}, {'id': 'OG005', 'title': 'Randomized Period: Natalizumab 150 mg SC Every 12 Weeks', 'description': 'Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'spread': '1.262', 'groupId': 'OG000'}, {'value': '0.02', 'spread': '0.151', 'groupId': 'OG001'}, {'value': '3.84', 'spread': '8.054', 'groupId': 'OG002'}, {'value': '3.08', 'spread': '8.216', 'groupId': 'OG003'}, {'value': '6.09', 'spread': '15.424', 'groupId': 'OG004'}, {'value': '6.44', 'spread': '11.285', 'groupId': 'OG005'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to Week 60', 'description': 'Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.', 'unitOfMeasure': 'lesions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified intent-to-treat (mITT) population: all randomized participants who received at least 1 dose of study drug, had at least 1 efficacy assessment, and had no statistical protocol deviations.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Natalizumab 300 mg Intravenous (IV) Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}, {'id': 'FG001', 'title': 'Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}, {'id': 'FG002', 'title': 'Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}, {'id': 'FG003', 'title': 'Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}, {'id': 'FG004', 'title': 'Natalizumab 150 mg IV Every 12 Weeks', 'description': 'Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}, {'id': 'FG005', 'title': 'Natalizumab 150 mg SC Every 12 Weeks', 'description': 'Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.'}], 'periods': [{'title': 'Randomized Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'groupId': 'FG003', 'numSubjects': '54'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '54'}, {'groupId': 'FG001', 'numSubjects': '45'}, {'groupId': 'FG002', 'numSubjects': '52'}, {'comment': '1 participant did not receive any study medication.', 'groupId': 'FG003', 'numSubjects': '53'}, {'groupId': 'FG004', 'numSubjects': '47'}, {'groupId': 'FG005', 'numSubjects': '38'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '43'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '9'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '43'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '45'}, {'groupId': 'FG005', 'numSubjects': '37'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Rescue', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '13'}, {'groupId': 'FG003', 'numSubjects': '10'}, {'groupId': 'FG004', 'numSubjects': '8'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'Incorrect Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Treatment Arm Closed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '36'}, {'groupId': 'FG004', 'numSubjects': '33'}, {'groupId': 'FG005', 'numSubjects': '28'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrew Prior to Dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Open-Label Treatment Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '1 participant discontinued randomized period due to an adverse event but entered open-label period.', 'groupId': 'FG000', 'numSubjects': '44'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '42'}, {'groupId': 'FG003', 'numSubjects': '42'}, {'groupId': 'FG004', 'numSubjects': '42'}, {'groupId': 'FG005', 'numSubjects': '32'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '40'}, {'groupId': 'FG001', 'numSubjects': '33'}, {'groupId': 'FG002', 'numSubjects': '39'}, {'groupId': 'FG003', 'numSubjects': '37'}, {'groupId': 'FG004', 'numSubjects': '40'}, {'groupId': 'FG005', 'numSubjects': '30'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': "Four of the 6 arms in the Randomized Treatment Period (the 'every 12 weeks' arms) were closed prematurely. Participants who completed randomized treatment, met rescue criteria, or were impacted by arm closure (and met rescue criteria) were eligible to enroll in the open-label treatment period."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}, {'value': '47', 'groupId': 'BG004'}, {'value': '38', 'groupId': 'BG005'}, {'value': '290', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks.'}, {'id': 'BG001', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks.'}, {'id': 'BG002', 'title': 'Randomized Period: Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.'}, {'id': 'BG003', 'title': 'Randomized Period: Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.'}, {'id': 'BG004', 'title': 'Randomized Period: Natalizumab 150 mg IV Every 12 Weeks', 'description': 'Natalizumab 150 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods.'}, {'id': 'BG005', 'title': 'Randomized Period: Natalizumab 150 mg SC Every 12 Weeks', 'description': 'Natalizumab 150 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '38.4', 'spread': '7.84', 'groupId': 'BG000'}, {'value': '36.3', 'spread': '8.92', 'groupId': 'BG001'}, {'value': '38.7', 'spread': '8.43', 'groupId': 'BG002'}, {'value': '38.7', 'spread': '7.85', 'groupId': 'BG003'}, {'value': '38.7', 'spread': '8.61', 'groupId': 'BG004'}, {'value': '36.0', 'spread': '9.03', 'groupId': 'BG005'}, {'value': '37.9', 'spread': '8.41', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '18 to 19 years', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': '20 to 29 years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '11', 'groupId': 'BG005'}, {'value': '48', 'groupId': 'BG006'}]}]}, {'title': '30 to 39 years', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}, {'value': '21', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '117', 'groupId': 'BG006'}]}]}, {'title': '40 to 49 years', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '95', 'groupId': 'BG006'}]}]}, {'title': '50 to 56 years', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '29', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}, {'value': '41', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}, {'value': '24', 'groupId': 'BG005'}, {'value': '204', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '86', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 290}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-03', 'studyFirstSubmitDate': '2011-07-14', 'resultsFirstSubmitDate': '2015-06-29', 'studyFirstSubmitQcDate': '2011-07-28', 'lastUpdatePostDateStruct': {'date': '2015-08-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-06-29', 'studyFirstPostDateStruct': {'date': '2011-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cumulative Number of Combined Unique Active Lesions', 'timeFrame': 'Up to Week 60', 'description': 'Cumulative number of combined unique active lesions (sum of the number of new gadolinium (Gd)-enhancing lesions and new or newly enlarging T2 hyperintense lesions not associated with Gd-enhancement on T1 weighted scans) based on brain magnetic resonance imaging (MRI) scans Up to Week 60.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Relapsing-Remitting Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to explore the effects of multiple regimens of natalizumab on disease activity and safety in participants with relapsing-remitting Multiple Sclerosis (RRMS).', 'detailedDescription': 'This is a a dose and frequency (but not route of administration) blinded, prospective, randomized, dose-ranging study in patients with RRMS who have received natalizumab for at least 12 months according to the local prescribing guidelines. The study will explore dosing of natalizumab by subcutaneous and intravenous routes. Participants will be randomly assigned to 1 of 6 dosing regimens, blinded to natalizumab dose, but not route, for 60 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Ability to provide written informed consent\n* Subjects of childbearing potential must practice effective contraception during the study\n* A documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS)\n* Free of MS relapse for 12 months prior to randomization\n* Treatment with natalizumab for a minimum of 12 months immediately prior to randomization.\n* In the 12 months prior to commencing natalizumab, subject must have experienced a minimal level of disease activity as defined by 2 or more documented clinical relapses OR 1 relapse and documented MRI activity, defined by the presence of at least 1 Gd enhancing lesion on MRI, unrelated to the relapse.\n\nKey Exclusion Criteria:\n\n* Known history of Human Immunodeficiency Virus (HIV), hepatitis C and/or hepatitis B virus\n* Positive for anti-natalizumab antibodies at screening\n* MRI positive for Gd-enhancing lesions at study entry\n* Subjects for whom MRI is contraindicated\n* History of any clinically significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic (including diabetes), urologic, pulmonary, neurologic (except for RRMS), dermatologic, psychiatric, renal, or other major disease\n* History of malignant disease, including solid tumors and hematologic malignancies (with the exception of cured basal cell and squamous cell carcinomas of the skin)\n* History of transplantation or any anti-rejection therapy\n* History of severe allergic or anaphylactic reactions or known hypersensitivity to any drug\n* A clinically significant infectious illness within 30 days prior to screening or progressive multifocal leukoencephalopathy (PML) or other opportunistic infections at any time\n* Signs or symptoms suggestive of any serious infection, based on medical history, physical examination or laboratory testing\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT01405820', 'acronym': 'REFINE', 'briefTitle': 'Exploratory Study of the Safety, Tolerability and Efficacy of Multiple Regimens of Natalizumab in Adult Participants With Relapsing Multiple Sclerosis (MS)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'A Randomized, Blinded, Parallel-Group, Phase 2 Study Exploring the Safety, Tolerability, and Efficacy of Multiple Regimens of Natalizumab in Adult Subjects With Relapsing Multiple Sclerosis', 'orgStudyIdInfo': {'id': '101MS206'}, 'secondaryIdInfos': [{'id': '2010-024000-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Natalizumab 300 mg Intravenous (IV) Every 4 Weeks', 'description': 'Natalizumab 300 mg IV every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'interventionNames': ['Drug: natalizumab IV']}, {'type': 'EXPERIMENTAL', 'label': 'Natalizumab 300 mg Subcutaneous (SC) Every 4 Weeks', 'description': 'Natalizumab 300 mg SC every 4 weeks for 60 weeks. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'interventionNames': ['Drug: natalizumab IV', 'Drug: natalizumab SC']}, {'type': 'EXPERIMENTAL', 'label': 'Natalizumab 300 mg IV Every 12 Weeks', 'description': 'Natalizumab 300 mg IV every 12 weeks for 60 weeks with matching IV placebo administered during the intervening 4-week periods. Open-label natalizumab treatment 300 mg IV at Weeks 60, 64, and 68.', 'interventionNames': ['Drug: natalizumab IV', 'Drug: IV Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Natalizumab 300 mg SC Every 12 Weeks', 'description': 'Natalizumab 300 mg SC every 12 weeks for 60 weeks with matching SC placebo administered during the intervening 4-week periods. 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