Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-25 @ 4:39 AM
Study NCT ID:
NCT03352557
Status:
TERMINATED
Last Update Posted:
2022-11-08
First Post:
2017-11-21
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-09-26', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000707052', 'term': 'gosuranemab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@biogen.com', 'phone': '866-633-4636', 'title': 'US Biogen Clinical Trial Center', 'organization': 'Biogen'}, 'certainAgreement': {'otherDetails': "Our agreement is subject to confidentiality but generally the PI can publish, for non-commercial 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}, 'limitationsAndCaveats': {'description': 'The study was terminated based on lack of efficacy following the placebo-controlled period readout.'}}, 'adverseEventsModule': {'timeFrame': 'From first dose through 14 weeks after last dose of study drug (Up to approximately 173 weeks)', 'description': "The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo). The all-cause mortality data and adverse events are reported for 'safety analysis set'.", 'eventGroups': [{'id': 'EG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 121, 'seriousNumAtRisk': 214, 'deathsNumAffected': 1, 'seriousNumAffected': 26}, {'id': 'EG001', 'title': 'PC Period: BIIB092 125 mg/4 Week', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 39, 'seriousNumAtRisk': 58, 'deathsNumAffected': 1, 'seriousNumAffected': 6}, {'id': 'EG002', 'title': 'PC Period: BIIB092 375 mg/12 Week', 'description': 'Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 38, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG003', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.', 'otherNumAtRisk': 106, 'deathsNumAtRisk': 106, 'otherNumAffected': 68, 'seriousNumAtRisk': 106, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG004', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 139, 'seriousNumAtRisk': 214, 'deathsNumAffected': 1, 'seriousNumAffected': 25}, {'id': 'EG005', 'title': 'LTE Period: BIIB092 125 mg/4 Week', 'description': 'Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.', 'otherNumAtRisk': 45, 'deathsNumAtRisk': 45, 'otherNumAffected': 10, 'seriousNumAtRisk': 45, 'deathsNumAffected': 2, 'seriousNumAffected': 5}, {'id': 'EG006', 'title': 'LTE Period: BIIB092 375 mg/12 Week', 'description': 'Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 11, 'seriousNumAtRisk': 49, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG007', 'title': 'LTE Period: BIIB092 600 mg/4 Week', 'description': 'Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.', 'otherNumAtRisk': 89, 'deathsNumAtRisk': 89, 'otherNumAffected': 19, 'seriousNumAtRisk': 89, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG008', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Early Start', 'description': 'Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.', 'otherNumAtRisk': 168, 'deathsNumAtRisk': 168, 'otherNumAffected': 28, 'seriousNumAtRisk': 168, 'deathsNumAffected': 1, 'seriousNumAffected': 10}, {'id': 'EG009', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Late Start', 'description': 'Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.', 'otherNumAtRisk': 165, 'deathsNumAtRisk': 165, 'otherNumAffected': 29, 'seriousNumAtRisk': 165, 'deathsNumAffected': 1, 'seriousNumAffected': 13}], 'otherEvents': [{'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 12}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 24}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 6}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 20}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 9}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 2}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 11}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 19}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 30}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 6}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 14}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 15}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 8}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Limb injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 19}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 6}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 2}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 5}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 7}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Neck pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 9}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 11}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 22}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 4}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 3}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 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'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 1}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Aortic aneurysm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Hypertensive crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Orthostatic hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}, {'term': 'Deep vein thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 106, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 214, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 45, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 89, 'numAffected': 0}, {'groupId': 'EG008', 'numAtRisk': 168, 'numAffected': 0}, {'groupId': 'EG009', 'numAtRisk': 165, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '58', 'groupId': 'OG002'}, {'value': '106', 'groupId': 'OG003'}, {'value': '214', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG001', 'title': 'PC Period: BIIB092 125 mg/4 Week', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG002', 'title': 'PC Period: BIIB092 375 mg/12 Week', 'description': 'Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.'}, {'id': 'OG003', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG004', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '84.6', 'groupId': 'OG000'}, {'value': '86.2', 'groupId': 'OG001'}, {'value': '82.8', 'groupId': 'OG002'}, {'value': '88.7', 'groupId': 'OG003'}, {'value': '88.3', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '12.1', 'groupId': 'OG000'}, {'value': '10.3', 'groupId': 'OG001'}, {'value': '10.3', 'groupId': 'OG002'}, {'value': '12.3', 'groupId': 'OG003'}, {'value': '11.7', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)', 'description': 'AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).'}, {'type': 'PRIMARY', 'title': 'LTE Period: Percentage of Participants With AEs and SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '45', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '89', 'groupId': 'OG002'}, {'value': '168', 'groupId': 'OG003'}, {'value': '165', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'LTE Period: BIIB092 125 mg/4 Week', 'description': 'Participants who received BIIB092, 125 mg, IV infusion during the PC Period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'OG001', 'title': 'LTE Period: BIIB092 375 mg/12 Week', 'description': 'Participants who received BIIB092, 375 mg, IV infusion during the PC Period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'OG002', 'title': 'LTE Period: BIIB092 600 mg/4 Week', 'description': 'Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'OG003', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Early Start', 'description': 'Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'OG004', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Late Start', 'description': 'Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}], 'classes': [{'title': 'AEs', 'categories': [{'measurements': [{'value': '68.9', 'groupId': 'OG000'}, {'value': '55.1', 'groupId': 'OG001'}, {'value': '58.4', 'groupId': 'OG002'}, {'value': '61.3', 'groupId': 'OG003'}, {'value': '60.0', 'groupId': 'OG004'}]}]}, {'title': 'SAEs', 'categories': [{'measurements': [{'value': '11.1', 'groupId': 'OG000'}, {'value': '2.0', 'groupId': 'OG001'}, {'value': '10.1', 'groupId': 'OG002'}, {'value': '6.0', 'groupId': 'OG003'}, {'value': '7.9', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From Week 80 to Week 173', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set included all randomized participants who received at least one dose of study treatment (BIIB092 or placebo).'}, {'type': 'SECONDARY', 'title': 'PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG001', 'title': 'PC Period: BIIB092 Low Dose', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks or BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.'}, {'id': 'OG002', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG003', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '116', 'groupId': 'OG001'}, {'value': '106', 'groupId': 'OG002'}, {'value': '214', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3.07', 'spread': '1.467', 'groupId': 'OG000'}, {'value': '2.92', 'spread': '1.620', 'groupId': 'OG001'}, {'value': '3.24', 'spread': '1.557', 'groupId': 'OG002'}, {'value': '3.04', 'spread': '1.378', 'groupId': 'OG003'}]}]}, {'title': 'Change at Week 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '98', 'groupId': 'OG001'}, {'value': '91', 'groupId': 'OG002'}, {'value': '174', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.71', 'spread': '2.376', 'groupId': 'OG000'}, {'value': '2.10', 'spread': '2.375', 'groupId': 'OG001'}, {'value': '2.23', 'spread': '2.987', 'groupId': 'OG002'}, {'value': '1.76', 'spread': '2.038', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 78', 'description': 'The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS included all randomized participants who received study treatment (BIIB092 or placebo). As pre-specified in study protocol, 125 mg and 375 mg groups were pooled as 'Low dose' group for efficacy analyses."}, {'type': 'SECONDARY', 'title': 'PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '211', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '105', 'groupId': 'OG003'}, {'value': '212', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG001', 'title': 'PC Period: BIIB092 125 mg/4 Week', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG002', 'title': 'PC Period: BIIB092 375 mg/12 Week', 'description': 'Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.'}, {'id': 'OG003', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'OG004', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.9', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1.0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Week 76', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The ADA evaluable set is defined as participants in the FAS who have an evaluable postbaseline ADA sample.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, intravenous (IV) infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'FG001', 'title': 'PC Period: BIIB092 125 mg/4 Week', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'FG002', 'title': 'PC Period: BIIB092 375 mg/12 Week', 'description': 'Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.'}, {'id': 'FG003', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'FG004', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'FG005', 'title': 'LTE Period: BIIB092 125 mg/4 Week', 'description': 'Participants who received BIIB092, 125 mg, IV infusion during the PC period, continued to receive BIIB092, 125 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'FG006', 'title': 'LTE Period: BIIB092 375 mg/12 Week', 'description': 'Participants who received BIIB092, 375 mg, IV infusion during the PC period, continued to receive BIIB092, 375 mg, IV infusion once every 12 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'FG007', 'title': 'LTE Period: BIIB092 600 mg/4 Week', 'description': 'Participants who received BIIB092, 600 mg, IV infusion during the PC period, continued to receive BIIB092, 600 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'FG008', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Early Start', 'description': 'Participants who received BIIB092, 2000 mg, IV infusion during the PC period, continued to receive BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}, {'id': 'FG009', 'title': 'LTE Period: BIIB092 2000 mg/4 Week - Late Start', 'description': 'Participants who received BIIB092-matching placebo, IV infusion during the PC period, received BIIB092, 2000 mg, IV infusion once every 4 weeks from Week 80 to Week 155 during the LTE period.'}], 'periods': [{'title': 'PC Period: Day 1 to Week 78', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'groupId': 'FG004', 'numSubjects': '218'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Safety Analysis Set', 'comment': 'Safety Analysis Set = Dosed Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'groupId': 'FG004', 'numSubjects': '214'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Full Analysis Set (FAS)', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '58'}, {'groupId': 'FG003', 'numSubjects': '106'}, {'groupId': 'FG004', 'numSubjects': '214'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Antidrug Antibody (ADA) Evaluable Set', 'achievements': [{'groupId': 'FG000', 'numSubjects': '211'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '105'}, {'groupId': 'FG004', 'numSubjects': '212'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '172'}, {'groupId': 'FG001', 'numSubjects': '48'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '91'}, {'groupId': 'FG004', 'numSubjects': '175'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '43'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Noncompliance with Study Drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Protocol Deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Randomized by Mistake', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '5'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Concern About Study Procedures/Perceived Risks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Relocation (Moving or Has Moved)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Desire for Change in Treatment (Unrelated to Safety)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '5'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Study Visit Burden/Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Concern About Study Procedures/Perceived Risks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Desire for Change in Treatment (Unrelated to Safety)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Physician Decision-Unrelated to Safety', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '3'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Not Dosed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}, {'title': 'LTE Period: Week 80 to Week 173', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'comment': '2 PC completers did not enter LTE.', 'groupId': 'FG005', 'numSubjects': '46'}, {'comment': '1 PC completer did not enter LTE.', 'groupId': 'FG006', 'numSubjects': '49'}, {'comment': '1 PC completer did not enter LTE.', 'groupId': 'FG007', 'numSubjects': '90'}, {'comment': '6 PC completers did not enter LTE.', 'groupId': 'FG008', 'numSubjects': '169'}, {'comment': '5 PC completers did not enter LTE.', 'groupId': 'FG009', 'numSubjects': '167'}]}, {'type': 'Safety Analysis Set', 'comment': 'Safety Analysis Set = Dosed Participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '45'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '89'}, {'groupId': 'FG008', 'numSubjects': '168'}, {'groupId': 'FG009', 'numSubjects': '165'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '46'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '90'}, {'groupId': 'FG008', 'numSubjects': '169'}, {'groupId': 'FG009', 'numSubjects': '167'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '3'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Site Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '38'}, {'groupId': 'FG006', 'numSubjects': '49'}, {'groupId': 'FG007', 'numSubjects': '75'}, {'groupId': 'FG008', 'numSubjects': '151'}, {'groupId': 'FG009', 'numSubjects': '154'}]}, {'type': 'Withdrawal by Participant-Study Visit Burden/Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '5'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Participant-Relocation (Moving or Has Moved)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Participant-Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '4'}]}, {'type': 'WBP/G-Study Visit Burden/Scheduling Conflicts', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'WBP/G-Concern About Study Procedures/Perceived Risks', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Relocation (Moving or Has Moved)', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Unable to Continue to Enable Participation due to Illness/Hospitalization/Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '2'}, {'groupId': 'FG008', 'numSubjects': '1'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'WBP/G-Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '3'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '0'}, {'groupId': 'FG008', 'numSubjects': '3'}, {'groupId': 'FG009', 'numSubjects': '1'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '2'}, {'groupId': 'FG009', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}, {'groupId': 'FG007', 'numSubjects': '1'}, {'groupId': 'FG008', 'numSubjects': '0'}, {'groupId': 'FG009', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were enrolled at approximately 100 investigational sites from 03 May 2018 to 30 August 2021.', 'preAssignmentDetails': "A total of 654 participants with Alzheimer's Disease (AD) were enrolled and randomized to receive placebo or BIIB092 125/375/600/2000 milligrams(mg) in Placebo-Controlled (PC) period. Following PC period, 521 participants entered and 516 were dosed in Long-term Extension (LTE) period, and no participants completed the study due to early termination of the study. WBP/G=Withdrawal by Parent/Guardian"}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '218', 'groupId': 'BG004'}, {'value': '654', 'groupId': 'BG005'}]}], 'groups': [{'id': 'BG000', 'title': 'PC Period: Placebo', 'description': 'Participants received BIIB092-matching placebo, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'BG001', 'title': 'PC Period: BIIB092 125 mg/4 Week', 'description': 'Participants received BIIB092, 125 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'BG002', 'title': 'PC Period: BIIB092 375 mg/12 Week', 'description': 'Participants received BIIB092, 375 mg, IV infusion, on Day 1 and then once every 12 weeks for 76 weeks during the PC period.'}, {'id': 'BG003', 'title': 'PC Period: BIIB092 600 mg/4 Week', 'description': 'Participants received BIIB092, 600 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'BG004', 'title': 'PC Period: BIIB092 2000 mg/4 Week', 'description': 'Participants received BIIB092, 2000 mg, IV infusion, on Day 1 and then once every 4 weeks for 76 weeks during the PC period.'}, {'id': 'BG005', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.8', 'spread': '6.63', 'groupId': 'BG000'}, {'value': '70.4', 'spread': '6.80', 'groupId': 'BG001'}, {'value': '70.3', 'spread': '6.79', 'groupId': 'BG002'}, {'value': '69.7', 'spread': '6.66', 'groupId': 'BG003'}, {'value': '69.4', 'spread': '7.11', 'groupId': 'BG004'}, {'value': '69.7', 'spread': '6.81', 'groupId': 'BG005'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '106', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}, {'value': '114', 'groupId': 'BG004'}, {'value': '329', 'groupId': 'BG005'}]}, {'title': 'Male', 'measurements': [{'value': '108', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '104', 'groupId': 'BG004'}, {'value': '325', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '17', 'groupId': 'BG005'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '208', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '103', 'groupId': 'BG003'}, {'value': '208', 'groupId': 'BG004'}, {'value': '627', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}]}, {'title': 'White', 'measurements': [{'value': '201', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}, {'value': '98', 'groupId': 'BG003'}, {'value': '206', 'groupId': 'BG004'}, {'value': '611', 'groupId': 'BG005'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '12', 'groupId': 'BG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Randomized participants included enrolled participants who received a randomization treatment assignment from the Interactive Response Technology (BIIB092 or placebo).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-01-13', 'size': 9683571, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-08-26T11:47', 'hasProtocol': True}, {'date': '2021-03-31', 'size': 2359554, 'label': 'Statistical Analysis Plan: Placebo-Controlled Period', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-18T15:15', 'hasProtocol': False}, {'date': '2021-09-16', 'size': 827313, 'label': 'Statistical Analysis Plan: Long-Term Extension Period', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-10-18T15:18', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 654}}, 'statusModule': {'whyStopped': 'The study (NCT03352557) was terminated based on lack of efficacy following the placebo-controlled period readout.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2018-05-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-18', 'studyFirstSubmitDate': '2017-11-21', 'resultsFirstSubmitDate': '2022-08-26', 'studyFirstSubmitQcDate': '2017-11-21', 'lastUpdatePostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-10-18', 'studyFirstPostDateStruct': {'date': '2017-11-24', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PC Period: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Day 1 to Week 78 (participants who entered LTE period); Day 1 up to Week 90 (participants who did not LTE period)', 'description': 'AE is any untoward medical occurrence in participant or clinical investigation participant administered pharmaceutical product and that does not necessarily have causal relationship with this treatment. AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with use of medicinal (investigational) product, whether or not related to medicinal (investigational) product. SAE is any untoward medical occurrence that at any dose, results in death; in view of investigator places participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in congenital anomaly/birth defect; is medically important event. Participants who completed treatment period in PC period and did not enter LTE period were to be assessed at Week 90 (14 weeks after end of treatment) as safety follow-up.'}, {'measure': 'LTE Period: Percentage of Participants With AEs and SAEs', 'timeFrame': 'From Week 80 to Week 173', 'description': 'An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE is any untoward medical occurrence that at any dose, results in death; in the view of the investigator places the participant at immediate risk of death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect; is a medically important event.'}], 'secondaryOutcomes': [{'measure': 'PC Period: Change From Baseline Over Time at Week 78 on the Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB) Score', 'timeFrame': 'Baseline, Week 78', 'description': 'The CDR-SB is a validated clinical assessment of global function in participants with AD. The CDR is comprised of 6 domains: Memory, Orientation, Judgment and Problem Solving, Community Affairs, Home and Hobbies, and Personal Care. CDR-SB is the sum of the scores for these 6 domains. Impairment is scored in each of 6 cognitive categories on a scale in which none = 0, questionable = 0.5, mild = 1, moderate = 2, and severe = 3. The 6 individual category ratings, or "box scores", can be added together to give the CDR-SB score which ranges from 0 (none) to 18 (severe impairment).'}, {'measure': 'PC Period: Percentage of Participants With Anti-BIIB092 Antibodies in Serum', 'timeFrame': 'Baseline up to Week 76'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild cognitive impairment', "Alzheimer's disease"], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '38012285', 'type': 'DERIVED', 'citation': "Shulman M, Kong J, O'Gorman J, Ratti E, Rajagovindan R, Viollet L, Huang E, Sharma S, Racine AM, Czerkowicz J, Graham D, Li Y, Hering H, Haeberlein SB. TANGO: a placebo-controlled randomized phase 2 study of efficacy and safety of the anti-tau monoclonal antibody gosuranemab in early Alzheimer's disease. Nat Aging. 2023 Dec;3(12):1591-1601. doi: 10.1038/s43587-023-00523-w. Epub 2023 Nov 27."}]}, 'descriptionModule': {'briefSummary': "The primary objective of the placebo-controlled period is to evaluate the safety and tolerability of BIIB092 in participants with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or with mild AD. The secondary objectives of the placebo-controlled period are to evaluate the efficacy of multiple doses of BIIB092 in slowing cognitive and functional impairment in participants with MCI due to AD or with mild AD, and to evaluate the immunogenicity of BIIB092 after multiple doses in participants with MCI due to AD or with mild AD.\n\nThe primary objective of the long-term extension period is to evaluate the long-term safety and tolerability of BIIB092 in participants with MCI due to AD or with mild AD."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Must have a gradual and progressive change in memory function over more than 6 months.\n* Must meet all of the clinical criteria for mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD and must have\n* Objective evidence of cognitive impairment at Screening\n* Clinical Dementia Rating Scale (CDR) global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD\n* Mini-Mental State Examination (MMSE) score of 22 to 30 (inclusive)\n* CDR Memory Box score of ≥0.5\n* Must consent to apolipoprotein E (ApoE) genotyping\n* Must have 1 informant/study partner\n* Must have amyloid beta positivity confirmed at Screening\n\nKey Exclusion Criteria:\n\n* Any medical or neurological/neurodegenerative condition (other than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns\n* Clinically significant, unstable psychiatric illness\n* Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year\n* Relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities\n* History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit 1\n* Indication of impaired renal or liver function\n* Alcohol or substance abuse in past 1 year\n* Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period\n* Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening Visit 1 and during the screening period up to Study Day 1.\n* Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.\n* Contraindications to study procedures\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply"}, 'identificationModule': {'nctId': 'NCT03352557', 'acronym': 'TANGO', 'briefTitle': "Phase 2 Study of BIIB092 in Participants With Early Alzheimer's Disease", 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': "Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Safety, Tolerability, and Efficacy of BIIB092 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease or With Mild Alzheimer's Disease", 'orgStudyIdInfo': {'id': '251AD201'}, 'secondaryIdInfos': [{'id': '2017-002901-37', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low-dose BIIB092', 'description': 'Intravenous (IV) infusion once every 4 weeks OR once every 12 weeks and placebo at the other 4-week dosing visits to maintain the treatment blind.', 'interventionNames': ['Drug: BIIB092']}, {'type': 'EXPERIMENTAL', 'label': 'Medium-dose BIIB092', 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