Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-25 @ 2:14 AM
Study NCT ID:
NCT04089566
Status:
COMPLETED
Last Update Posted:
2025-06-05
First Post:
2019-09-11
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Australia', 'France', 'Greece', 'Ireland', 'Israel', 'Latvia', 'Netherlands', 'South Korea', 'Turkey (Türkiye)', 'United Kingdom'], 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009134', 'term': 'Muscular Atrophy, Spinal'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D016472', 'term': 'Motor Neuron Disease'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000590926', 'term': 'nusinersen'}]}}, '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 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': 'Part A: From first dose of the study up to Day 389 Part B: From first dose of the study up to Day 399 Part C: From first dose of the study up to Day 361', 'description': 'Safety set included all participants who received at least one dose of nusinersen in this study. MedDRA version 24.0 was applied for Part A, MedDRA version 26.1 was applied for Part B, and MedDRA version 26.0 was applied for Part C.', 'eventGroups': [{'id': 'EG000', 'title': 'Part A: 28/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen, IT, on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 19, 'seriousNumAtRisk': 25, 'deathsNumAffected': 6, 'seriousNumAffected': 18}, {'id': 'EG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.', 'otherNumAtRisk': 50, 'deathsNumAtRisk': 50, 'otherNumAffected': 37, 'seriousNumAtRisk': 50, 'deathsNumAffected': 10, 'seriousNumAffected': 30}, {'id': 'EG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 14, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 36, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 6}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 5}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Balance disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Dizziness postural', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Intracranial pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Bulbar palsy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Febrile convulsion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 4}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 7}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Gastrooesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Dysbiosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Functional gastrointestinal disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Infantile diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Salivary hypersecretion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Gingivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 5}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 1}], 'organSystem': 'Infections and 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[{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Oxygen saturation decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Hypoglycaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Acquired macrocephaly', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Muscular weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Brain stem infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Cerebral infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Hypoglycaemic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Chronic respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Interstitial lung disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Obstructive airways disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Respiratory acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Respiratory arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Respiratory disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Respiratory distress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}, {'term': 'Shock haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 25, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 50, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 40, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA24,26,26.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (NCT02193074), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '42.9', 'groupId': 'OG000', 'lowerLimit': '38.7', 'upperLimit': '47.2'}, {'value': '16.9', 'groupId': 'OG001', 'lowerLimit': '10.1', 'upperLimit': '23.7'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least square (LS) mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.06', 'ciLowerLimit': '17.941', 'ciUpperLimit': '34.172', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.141', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'nonInferiorityComment': 'The Analysis of Covariance (ANCOVA) model used rank score as response, treatment as fixed effect and disease duration at screening, baseline Hammersmith Infant Neurological Examination (HINE) Section 2 (HINE 2), baseline CHOP INTEND total score as covariates.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 183', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score). The change from baseline to Day 183 in the CHOP-INTEND total score was compared to CS3B study (NCT02193074) sham control group using the joint-rank methodology to account for mortality.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of the CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set.'}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part A: From the first dose of the study drug up to Day 389, Part C: From the first dose of the study drug up to Day 361', 'description': 'An adverse event (AE) was any unfavorable \\& unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with use of an investigational product, whether or not related to investigational product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AE and SAEs were regarded as treatment-emergent if it was present prior to receiving first dose of nusinersen in this current study and subsequently worsened in severity or was not present prior to receiving first dose of nusinersen and subsequently appeared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Alkaline Phosphatase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Alanine Aminotransferase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Aspartate Aminotransferase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Bicarbonate Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Bilirubin Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Indirect Bilirubin Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Calcium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatine Kinase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chloride Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Creatinine Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Potassium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Phosphate Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Sodium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Urea Nitrogen Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Blood chemistry parameters included protein, albumin, creatinine, blood urea nitrogen, bilirubin (total and direct), alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium, potassium, cystatin C, and creatine kinase. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. Number analyzed 'n' indicates the number of participants evaluable for analysis of the specified parameter."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Basophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Basophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Eosinophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Hematocrit Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Hemoglobin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Lymphocytes/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Monocytes/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Neutrophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Platelets Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Platelets Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Hematology parameters included complete blood cell count, with differential and platelet count, and absolute neutrophil count. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified hematology parameter."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Specific Gravity Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'pH Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Protein High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': 'Glucose High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Ketones High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Occult Blood High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'RBC High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'WBC High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Epithelial Cells High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Bacteria High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Urinalysis included assessments of urine total protein, specific gravity, pH, protein, glucose, ketones, bilirubin, blood, red blood cells (RBC), white blood cells (WBC), epithelial cells, bacteria, casts and crystals. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified urinalysis parameter."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Cerebrospinal Fluid (CSF) Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Glucose Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Glucose Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Protein Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Protein Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Erythrocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Part A: Baseline up to Day 269, Part C: Baseline up to Day 241', 'description': "CSF parameters included cell count, total protein, and glucose. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' indicates the number of participants evaluable for the specified urinalysis parameter."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Electrocardiograms (ECGs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Baseline: Normal; Postbaseline: Normal', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Normal; Post-baseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Abnormal, not AE; Post-baseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}]}, {'title': 'Baseline: Unknown; Post-baseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'The ECGs were assessed by the investigator to be normal, abnormal and abnormal AE. The number of participants with ECG shifts from normal to each of the categorical values denoting an abnormal scan (abnormal not AE, abnormal AE) was assessed. Shift from baseline to worst post-baseline values were reported. The categories with at least one participant with shift from baseline in ECG are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Abnormalities in Vital Sign Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Temperature <36.0 C', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate <60 bpm', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Pulse rate >100 bpm', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure <90 mmHg', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Systolic blood pressure >140 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure <50 mmHg', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic blood pressure >90 mmHg', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory rate <12 breaths/min', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Respiratory rate >20 breaths/min', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'Vital sign assessment included temperature, pulse rate, systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \\< 36.0 and \\> 38.0 degrees Celsius (C), pulse rate \\< 60 and \\> 100 beats per minute (bpm), systolic blood pressure \\[\\< 90, \\> 140 and \\> 160 millimeters of mercury (mmHg)\\], diastolic blood pressure \\< 50, \\> 90 and \\> 100 mmHg and respiratory rate \\< 12 and \\> 20 breaths per minute. The categories with at least one participant with clinically relevant vital sign abnormalities are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'PRIMARY', 'title': 'Parts A and C: Change From Baseline in Growth Parameters (Body Height)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.2', 'spread': '1.70', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '3.12', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'unitOfMeasure': 'centimeter (cm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline in Growth Parameters (Head Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable, standard deviation (SD) was not estimated', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head circumference was measured for participants with infantile-onset SMA only.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline in Growth Parameters (Chest Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': 'NA', 'comment': 'Since only one participant was evaluable, SD was not estimated', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in protocol, chest circumference was measured for participants with infantile-onset SMA only.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline in Growth Parameters (Arm Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable, SD was not estimated', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, arm circumference was measured for participants with infantile-onset SMA. Here, negative change from baseline indicated reduction in arm circumference.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Change From Baseline in Growth Parameters (Ulnar Length)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '1.43', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '1.27', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'As pre-specified in the protocol, ulnar length was measured for participants with later-onset SMA.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Change From Baseline in Growth Parameters (Weight for Age Percentile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '12.84', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '9.47', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'World Health Organization (WHO) child growth standards (2006) was used to calculate the weight for age percentile in the infantile-onset participants while the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts was used to calculate the weight for age percentile for later-onset participants. Negative change from baseline indicates low weight for age percentile.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline in Growth Parameters (Weight for Length Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.005', 'spread': 'NA', 'comment': 'Since only one participant was evaluated, SD was not estimable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, weight for length ratio was assessed only for the participants with infantile-onset SMA.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Part C: Change From Baseline in Growth Parameters (Head-to-Chest Circumference Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable, SD was not estimated', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head to chest circumference ratio was assessed only for the participants with infantile-onset SMA.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Activated Partial Thromboplastin Time (aPTT))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'Activated partial thromboplastin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of aPTT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of aPTT at baseline to high values postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C:ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Prothrombin Time (PT))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'Prothrombin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of PT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of PT at baseline to high values postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (International Normalized Ratio (INR))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'INR was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of INR at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of INR at baseline to high values postbaseline. The category with at least one participant with shift from baseline in INR ratio is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Change From Baseline in Urine Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.010', 'spread': '0.1235', 'groupId': 'OG000'}, {'value': '-0.692', 'spread': '3.7040', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'unitOfMeasure': 'gram per litre (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at specified timepoint."}, {'type': 'PRIMARY', 'title': 'Parts A and C: Number of Participants With Neurological Examination Abnormalities Reported as AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Vestibular Disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Asthenia', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Gait Disturbance', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Balance Disorder', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Disturbance in Attention', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Paraesthesia', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'Participants with abnormalities in neurological examinations recorded as AEs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'PRIMARY', 'title': 'Parts A and C: Percentage of Participants With a Postbaseline Platelet Count Below the Lower Limit of Normal on at Least 2 Consecutive Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'PRIMARY', 'title': "Parts A and C: Percentage of Participants With a Postbaseline Corrected QT Interval Using Fridericia's Formula (QTcF) of > 500 Millisecond (Msec) and an Increase From Baseline to Any Postbaseline Timepoint in QTcF of > 60 Msec", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Part A: Safety set included all participants who received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Percentage of Hammersmith Infant Neurological Examination (HINE) Section 2 Motor Milestone Responders for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment, IT, on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (NCT02193074), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '58', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference of percentages', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '58', 'ciLowerLimit': '39.46', 'ciUpperLimit': '71.81', 'estimateComment': 'Exact unconditional confidence interval', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Day 183', 'description': "Section 2 of HINE was used to assess motor milestones of participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, \\& walking. Motor milestone responder: (i) a participant that demonstrated at least a 2-point increase in category of ability to kick or maximal score on that category or a 1-point increase in category of head control, rolling, sitting, crawling, standing, or walking, (ii) improvement in more categories than worsening, excluding category of voluntary grasp. For category of ability to kick, improvement, as defined in (i), worsening: at least a 2-point decrease or decrease to lowest possible score of no kicking. For other 6 categories, improvement: 1-point increase, worsening: at least 1-point decrease. Participants who died or withdrew from study were considered as non-responders. Difference in percentage of responders reported using Fisher's exact test.", 'unitOfMeasure': 'percentage of responders', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in HINE Section 2 Motor Milestones Total Score for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment, IT, on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (NCT02193074), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '43.1', 'groupId': 'OG000', 'lowerLimit': '39.0', 'upperLimit': '47.2'}, {'value': '16.5', 'groupId': 'OG001', 'lowerLimit': '9.9', 'upperLimit': '23.0'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '26.67', 'ciLowerLimit': '18.812', 'ciUpperLimit': '34.526', 'pValueComment': 'ANCOVA model was used treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.009', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 183', 'description': "Section 2 of the HINE was used to assess motor milestones of the participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each category, 3 to 5 levels can be achieved. The total HINE section 2 motor milestones score was calculated as sum of each level \\& ranged from 0 to 26, higher score indicating improvement in motor milestones. A negative change from baseline indicates decline in motor milestones. Change from baseline in HINE section 2 motor milestones total score was compared to study CS3B (NCT02193074) matched sham control group, and was analysed using joint rank methodology.", 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in ITT set.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of Neurofilament Light Chain (NF-L) for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment, IT, on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (NCT02193074), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.07'}, {'value': '0.70', 'groupId': 'OG001', 'lowerLimit': '0.43', 'upperLimit': '1.12'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS geometric mean ratio', 'paramValue': '0.08', 'pValueComment': 'ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 183', 'description': 'The change from baseline in the plasma concentration of NF-L was compared to the study CS3B (NCT02193074) matched sham control group. Joint rank methodology was used for the analysis to account for mortality. The change from baseline data was reported in terms of least square geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of the CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '37.3', 'groupId': 'OG000', 'lowerLimit': '29.1', 'upperLimit': '45.5'}, {'value': '38.3', 'groupId': 'OG001', 'lowerLimit': '32.7', 'upperLimit': '44.0'}]}]}], 'analyses': [{'pValue': '=0.8484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1', 'ciLowerLimit': '-9.29', 'ciUpperLimit': '11.299', 'pValueComment': 'ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '5.251', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score). The change from baseline to Day 302 in the total score was analyzed using the joint-rank methodology to account for mortality.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in HINE Section 2 Motor Milestones Total Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '33.9', 'groupId': 'OG000', 'lowerLimit': '26.9', 'upperLimit': '41.0'}, {'value': '40.0', 'groupId': 'OG001', 'lowerLimit': '35.1', 'upperLimit': '44.9'}]}]}], 'analyses': [{'pValue': '=0.1734', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '6.12', 'ciLowerLimit': '-2.693', 'ciUpperLimit': '14.939', 'pValueComment': 'ANCOVA model used rank score as response, treatment as fixed effect and disease duration at screening, baseline HINE 2, baseline CHOP INTEND total score as covariates.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '4.497', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': "Section 2 of the HINE was used to assess motor milestones of the participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. The total motor milestones score for HINE section was calculated as the sum of each level and ranged from 0 to a maximum score of 26, higher score indicating improvement in motor milestones.", 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.23', 'groupId': 'OG000', 'lowerLimit': '0.16', 'upperLimit': '0.32'}, {'value': '0.12', 'groupId': 'OG001', 'lowerLimit': '0.09', 'upperLimit': '0.15'}]}]}], 'analyses': [{'pValue': '=0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.51', 'ciLowerLimit': '0.33', 'ciUpperLimit': '0.78', 'pValueComment': 'ANCOVA model was used with treatment as a fixed effect and adjustment for each participant disease duration at screening, baseline log plasma NF-L and baseline CHOP INTEND total score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 64', 'description': 'The change from baseline in plasma concentration of NF-L was analysed using the joint rank methodology to account for mortality. The change from baseline data was reported in terms of LS geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment, IT, on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (NCT02193074), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and confidence interval were not estimable due to low number events of permanent ventilation or death.', 'groupId': 'OG000', 'lowerLimit': '39.86', 'upperLimit': 'NA'}, {'value': '19.1', 'groupId': 'OG001', 'lowerLimit': '10.00', 'upperLimit': '31.29'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to Day 399', 'description': 'Permanent ventilation was defined as tracheostomy or ≥ 16 hours of ventilation/day continuously for \\> 21 days in absence of an acute reversible event. An independent endpoint adjudication committee (EAC) determined date at which a participant was considered to have met protocol-specified criteria of an acute reversible event. Only events that were adjudicated by the EAC as meeting the criteria for permanent ventilation or death were included in analysis. Participants who did not meet the endpoint definition were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of the CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Time to Death (Overall Survival) for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG001', 'title': 'CS3B Matched Sham Control Group', 'description': 'Historical data of participants who received sham treatment, IT, on Days 1, 15, 29, 64, 183, and 302 in the double-blind, phase 3 study CS3B (2013-004422-29), was used as control in the current study.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and confidence interval were not estimable due to low number of events of death.', 'groupId': 'OG000', 'lowerLimit': 'NA', 'upperLimit': 'NA'}, {'value': '33.6', 'comment': 'Upper range 95% CI was not estimable due to low number of events of death.', 'groupId': 'OG001', 'lowerLimit': '11.29', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to Day 399', 'description': 'Time to death was determined by an independent EAC. Time to death (overall survival) was compared to the study CS3B (NCT02193074) matched sham control group.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'As planned, analysis was performed in the Matched sham set. Matched sham set comprised of sham control participants of the CS3B study (NCT02193074) identified by a matching algorithm and all of current study 50/28 mg participants that were included in the ITT set.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.7', 'comment': 'Upper range 95% CI was not estimable due to low number of events of permanent ventilation or death.', 'groupId': 'OG000', 'lowerLimit': '14.43', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and confidence interval were not estimable due to low number of events of permanent ventilation or death.', 'groupId': 'OG001', 'lowerLimit': '39.86', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to Day 399', 'description': 'Permanent ventilation was defined as tracheostomy or ≥ 16 hours of ventilation/day continuously for \\> 21 days in the absence of an acute reversible event. An independent EAC determined the date at which a participant was considered to have met the protocol-specified criteria of an acute reversible event. Only events that were adjudicated by the EAC as meeting the protocol defined criteria for permanent ventilation or death was included in the analysis. Participants who did not meet the endpoint definition were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Time to Death (Overall Survival) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'Median and confidence interval were not estimable due to low number events of death.', 'groupId': 'OG000', 'lowerLimit': '24.71', 'upperLimit': 'NA'}, {'value': 'NA', 'comment': 'Median and confidence interval were not estimable due to low number events of death.', 'groupId': 'OG001', 'lowerLimit': 'NA', 'upperLimit': 'NA'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Screening up to Day 399', 'description': 'Time to death was determined by an independent EAC. Participants who did not die were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.', 'unitOfMeasure': 'weeks', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '5.1'}, {'value': '3.3', 'groupId': 'OG001', 'lowerLimit': '1.5', 'upperLimit': '5.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'HFMSE scale was a tool used to assess motor function in children with later-onset SMA. The original 20 item Hammersmith Functional Motor Scale was expanded to include 13 additional adapted items from the Gross Motor Function Measure to improve sensitivity for the higher functioning ambulant population. Each item is scored 0 (unable), 1 (performs with modification or adaptation) or 2 (able) and the total score was calculated by summing the 33 items and ranged from 0 to 66 with higher scores indicating greater motor function.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From Baseline in Revised Upper Limb Module (RULM) Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'groupId': 'OG000', 'lowerLimit': '-0.8', 'upperLimit': '4.4'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '0.7', 'upperLimit': '4.2'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'RULM test was developed to assess upper limb functional abilities. RULM test: total 20 items. First item was assessed on 7-point scale (0:No useful function to 6-Can abduct both arms simultaneously, elbows in extension in full circle until they touch above head). This first item did not contribute to total score. For remaining 19 items, 18 items were assessed on 3-point scale: 0-Unable to achieve independently; 1-Modified method but achieves goal independent of physical assistance from another person; 2-Normal -achieves goal without any assistance. One remaining item was assessed as either 0 or 1. For each item, score was collected on left \\& right side. Derived total score=summing scores from these 19 individual items ranging from 0-if participant fails all activities to 37-if participant achieves all activities. If, for an individual item, response was recorded for both left \\& right side, highest score was used in calculating total score. Higher scores=increased upper limb function.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Number of New World Health Organization (WHO) Motor Milestones Achieved Per Participant for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': "The WHO motor milestones were a set of six milestones in motor development: sitting without support, standing with assistance, hands and knees crawling, walking with assistance, standing alone and walking alone. The examiner recorded an overall rating of the participant's emotional state and then for each milestone one of the following four classifications: no (inability) - child tried but failed to perform the milestone, no (refusal) - child refused to perform despite being calm and alert, yes - child was able to perform the milestone, unable to test - could not be tested because of irritability, drowsiness or sickness. Mean of number of new milestones achieved per participant was calculated and reported in this outcome measure.", 'unitOfMeasure': 'motor milestones per participant', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who were randomized and received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Feeding/Grooming/Dressing Total Score', 'categories': [{'measurements': [{'value': '7.9', 'groupId': 'OG000', 'lowerLimit': '-4.8', 'upperLimit': '20.6'}, {'value': '8.3', 'groupId': 'OG001', 'lowerLimit': '-0.2', 'upperLimit': '16.7'}]}]}, {'title': 'Sitting/Play Total Score', 'categories': [{'measurements': [{'value': '10.3', 'groupId': 'OG000', 'lowerLimit': '0.6', 'upperLimit': '20.0'}, {'value': '10.1', 'groupId': 'OG001', 'lowerLimit': '3.6', 'upperLimit': '16.6'}]}]}, {'title': 'Transfers Total Score', 'categories': [{'measurements': [{'value': '-0.0', 'groupId': 'OG000', 'lowerLimit': '-10.9', 'upperLimit': '10.9'}, {'value': '9.9', 'groupId': 'OG001', 'lowerLimit': '2.6', 'upperLimit': '17.2'}]}]}, {'title': 'Mobility Total Score', 'categories': [{'measurements': [{'value': '6.9', 'groupId': 'OG000', 'lowerLimit': '-7.2', 'upperLimit': '20.9'}, {'value': '8.1', 'groupId': 'OG001', 'lowerLimit': '-0.9', 'upperLimit': '17.0'}]}]}, {'title': 'Time Total Score', 'categories': [{'measurements': [{'value': '-4.4', 'groupId': 'OG000', 'lowerLimit': '-17.9', 'upperLimit': '9.2'}, {'value': '11.9', 'groupId': 'OG001', 'lowerLimit': '2.9', 'upperLimit': '20.9'}]}]}, {'title': 'Emotion Total Score', 'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-8.7', 'upperLimit': '13.9'}, {'value': '2.5', 'groupId': 'OG001', 'lowerLimit': '-5.0', 'upperLimit': '10.0'}]}]}, {'title': 'Finance Total Score', 'categories': [{'measurements': [{'value': '-7.7', 'groupId': 'OG000', 'lowerLimit': '-20.9', 'upperLimit': '5.6'}, {'value': '7.8', 'groupId': 'OG001', 'lowerLimit': '-0.7', 'upperLimit': '31.7'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'ACEND instrument was designed to quantify caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The ACEND included a total of seven domains assessing physical impact (including feeding/grooming/dressing, sitting/play, transfers, and mobility) and general caregiver impact (including time, emotion, and finance, and each domain comprised several items. The total score for each domain was calculated on a scale of 0 to 100, with a higher score indicating a decreased caregiver burden. A negative change from baseline indicates an increased caregiver burden.', 'unitOfMeasure': 'score on scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From Baseline in Pediatric Quality of Life Inventory™ (PedsQL) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'PQLI-Total Score-Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-5.1', 'spread': '4.73', 'groupId': 'OG000'}, {'value': '3.8', 'spread': '2.61', 'groupId': 'OG001'}]}]}, {'title': 'PQLI-Total Score-Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-9.6', 'spread': '4.32', 'groupId': 'OG000'}, {'value': '-6.9', 'spread': '2.96', 'groupId': 'OG001'}]}]}, {'title': 'PQLN-Total Score-Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '3.41', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '1.91', 'groupId': 'OG001'}]}]}, {'title': 'PQLN-Total Score-Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-6.4', 'spread': '4.25', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '2.81', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': "Participants were evaluated using PedsQL generic core scale \\& neuromuscular module. PedsQL generic core scale was used to calculate PedsQL inventory total score (PQLI), that included parent \\& participant's assessment on 4 dimensions: physical, emotional, social, \\& school functioning \\& psychosocial health. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). PedsQL neuromuscular module (PQLN) measured HRQOL dimensions specific to with neuromuscular disorders, like SMA. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). Dimensions were reversed scored \\& were linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) for both PQLI and PQLN, higher scores indicative of better health related quality of life. Total scale scores were calculated as sum of all items over number of items answered on all scales. If more than 50% of items/more within a dimension were missing, scale score was not computed.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who were randomized and received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)' indicates number of participants evaluable for the specified total score"}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From (Ratio to) Baseline in CSF Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.32', 'groupId': 'OG000', 'lowerLimit': '0.23', 'upperLimit': '0.450'}, {'value': '0.33', 'groupId': 'OG001', 'lowerLimit': '0.26', 'upperLimit': '0.41'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 279', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B Later-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.28', 'groupId': 'OG000', 'lowerLimit': '0.14', 'upperLimit': '0.56'}, {'value': '0.35', 'groupId': 'OG001', 'lowerLimit': '0.24', 'upperLimit': '0.51'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who were randomized and received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With TEAEs and TESAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'TEAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}]}, {'title': 'TESAEs', 'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From the first dose of the study drug up to Day 399', 'description': 'AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AE was regarded as treatment-emergent if it was present prior to receiving the first dose of nusinersen in the current study and subsequently worsened in severity or was not present prior to receiving the first dose of nusinersen and subsequently appeared.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Basophils Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Basophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Basophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Eosinophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hematocrit Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Hemoglobin Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte Atypical Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte Atypical/ Leukocyte Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte/Leukocyte Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Lymphocyte/Leukocyte Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocyte Mean Corpuscular Vol Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocyte Mean Corpuscular Vol Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Monocytes/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils/Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Neutrophils/Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Platelets Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Platelets Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': "Hematology parameters included complete blood cell count, with differential and platelet count, and absolute neutrophil count. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for analysis of the specified hematology parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Albumin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Albumin Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alkaline Phosphatase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Alanine Aminotransferase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Aspartate Aminotransferase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bicarbonate Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Bicarbonate Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Direct Bilirubin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Bilirubin Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Indirect Bilirubin Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Calcium Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Calcium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Creatine Kinase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Chloride Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Chloride Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Creatinine Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Cystatin C Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Cystatin C Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Gamma Glutamyl Transferase Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Gamma Glutamyl Transferase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Glucose Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Glucose Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}]}, {'title': 'Potassium Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Potassium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Lactate Dehydrogenase Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Magnesium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Phosphate Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Phosphate Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Protein Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Protein Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Sodium Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}]}, {'title': 'Sodium Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Urea Nitrogen Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Urea Nitrogen Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '23', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': "Blood chemistry parameters included protein, albumin, creatinine, blood urea nitrogen, bilirubin (total and direct), alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium, potassium, cystatin C, and creatine kinase. Parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for analysis of the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Urinalysis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Specific Gravity Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Specific Gravity Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'pH Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'pH Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Protein High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '9', 'groupId': 'OG003'}]}]}, {'title': 'Glucose High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Ketones High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Occult Blood High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'RBC High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'WBC High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Epithelial Cells High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Bacteria High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}]}, {'title': 'Casts High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Crystals High/positive', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': "Urinalysis included assessments of urine total protein, specific gravity, pH, protein, glucose, ketones, bilirubin, blood, RBC , WBC, epithelial cells, bacteria, casts and crystals. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high, positive, abnormal or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, negative, absent, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for analysis of the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in CSF Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Glucose Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Glucose Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Protein Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Protein Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Erythrocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Leukocytes Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': "CSF parameters included cell count, total protein, and glucose. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)' signifies number of participants evaluable for analysis of the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shift From Baseline in ECGs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Baseline: Normal; Postbaseline: Normal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Normal ; Postbaseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Normal; Postbaseline: Abnormal, AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Abnormal, not AE; Postbaseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '12', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Abnormal, not AE; Postbaseline: Abnormal, AE', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Baseline: Unknown; Postbaseline: Abnormal, not AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': 'The ECGs were assessed by the investigator to be normal, abnormal and abnormal AE. The number of participants with ECG shifts from normal to each of the categorical values denoting an abnormal scan (abnormal not AE, abnormal AE) was assessed. Shift from baseline to worst post-baseline values were reported. The categories with at least one participant with shift from baseline in ECG are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Abnormalities in Vital Sign Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Temperature <36.0 C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}]}]}, {'title': 'Temperature >38.0 C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Rate <60 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Pulse Rate >100 bpm', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}, {'title': 'Systolic Blood Pressure <90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Systolic Blood Pressure >140 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure <50 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure >90 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Diastolic Blood Pressure >100 mmHg', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory Rate <12 breaths/min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Respiratory Rate >20 breaths/min', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': 'Vital sign assessment included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \\< 36.0 and \\> 38.0 degrees C, pulse rate \\< 60 and \\> 100 bpm, systolic blood pressure \\< 90, \\> 140 and \\> 160 mmHg, diastolic blood pressure \\< 50, \\> 90 and \\> 100 mmHg and respiratory rate \\< 12 and \\> 20 breaths per minute. The categories with at least one participant with clinically relevant vital sign abnormalities are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for analysis of the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Growth Parameters (Body Height)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable SD was not estimable.', 'groupId': 'OG000'}, {'value': '10.25', 'spread': '2.217', 'groupId': 'OG001'}, {'value': '11.2', 'spread': 'NA', 'comment': 'Since only one participant was evaluable SD was not estimable.', 'groupId': 'OG002'}, {'value': '6.9', 'spread': '3.65', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'Body height was measured for all participants (infantile-onset and later-onset SMA).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Head Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.52', 'spread': '1.703', 'groupId': 'OG000'}, {'value': '5.50', 'spread': '2.766', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'Head circumference was measured in participants with infantile-onset SMA.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Chest Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.67', 'spread': '4.868', 'groupId': 'OG000'}, {'value': '6.64', 'spread': '6.362', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'Chest circumference was measured in participants with infantile-onset SMA.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Arm Circumference)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.45', 'spread': '2.141', 'groupId': 'OG000'}, {'value': '1.16', 'spread': '2.144', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'Arm circumference was measured in participants with infantile-onset SMA.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Growth Parameters (Ulnar Length)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '4.16', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.39', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'Ulnar length was measured in participants with later-onset SMA.', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Growth Parameters (Weight for Age Percentile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.70', 'spread': '23.133', 'groupId': 'OG000'}, {'value': '-3.60', 'spread': '35.202', 'groupId': 'OG001'}, {'value': '9.1', 'spread': '20.23', 'groupId': 'OG002'}, {'value': '-0.3', 'spread': '6.96', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'WHO child growth standards (2006) was used to calculate the weight for age percentile in the infantile-onset participants. The 2000 CDC Growth Charts was used to calculate the weight for age percentile for later-onset participants. Negative change from baseline indicates reduction in weight for age percentile', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Growth Parameters (Weight for Length Percentile)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '30', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '-4.23', 'spread': '35.817', 'groupId': 'OG000'}, {'value': '6.05', 'spread': '40.119', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, weight for length percentile was assessed only for the participants with infantile-onset SMA. Negative change from baseline indicates reduction in weight for length percentile.', 'unitOfMeasure': 'percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Growth Parameters (Head-to-Chest Circumference Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.085', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.269', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head to chest circumference ratio was assessed only for the participants with infantile-onset SMA. Negative change from baseline indicates reduction in head-to-chest circumference ratio.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure at the specified time point."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (aPTT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '40', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 279', 'description': 'aPTT was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of aPTT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of aPTT at baseline to high values postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (PT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 279', 'description': 'Prothrombin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of PT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of PT at baseline to high values postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (INR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Shift to Low', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Shift to High', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 279', 'description': 'INR was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of INR at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of INR at baseline to high values postbaseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies number of participants evaluable for the specified category."}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in Urine Total Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '11', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.130', 'spread': '0.4126', 'groupId': 'OG000'}, {'value': '-3.274', 'spread': '14.1387', 'groupId': 'OG001'}, {'value': '-0.213', 'spread': '0.2873', 'groupId': 'OG002'}, {'value': '0.004', 'spread': '0.0608', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'unitOfMeasure': 'grams per liter (g/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Part B: Number of Participants With Neurological Examination Abnormalities Reported as AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Muscular Weakness', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Bulbar Palsy', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}, {'title': 'Tremor', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Day 302', 'description': 'Participants with abnormalities in neurological examinations recorded as AEs were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants With a Postbaseline Platelet Count Below the Lower Limit of Normal on at Least 2 Consecutive Measurements', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 302', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety set included all participants who received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B: Percentage of Participants With a Postbaseline QTcF of > 500 Msec and an Increase From Baseline to Any Postbaseline Timepoint in QTcF of > 60 Msec', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to Day 302', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety set included all participants who received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts A, B and C: Number of Participants With Hospitalizations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA received 4 loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG005', 'title': 'Part C: Nusinersen 50/28 mg', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '12', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 302', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Parts A, B and C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'SECONDARY', 'title': 'Parts A, B and C: Percentage of Time of Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '2'}, {'value': '6.4', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '1.9', 'groupId': 'OG002', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '0.0', 'groupId': 'OG003', 'lowerLimit': '0', 'upperLimit': '8'}, {'value': '0.0', 'groupId': 'OG004', 'lowerLimit': '0', 'upperLimit': '11'}, {'value': '1.34', 'groupId': 'OG005', 'lowerLimit': '0.3', 'upperLimit': '10.4'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 302', 'unitOfMeasure': 'percentage of days', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Parts A, B and C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'SECONDARY', 'title': 'Parts A, B and C: Number of Participants With Clinical Global Impression of Change (CGIC)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'CGIC-I', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}, {'title': 'Much Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '20', 'groupId': 'OG002'}, {'value': '3', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'Minimally Improved', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '9', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '14', 'groupId': 'OG005'}]}, {'title': 'Minimally Worse', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}, {'title': 'CGIC-C', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '7', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '24', 'groupId': 'OG005'}]}], 'categories': [{'title': 'Very Much Improved', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}, {'title': 'Much Improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '8', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}]}, {'title': 'Minimally Improved', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '7', 'groupId': 'OG004'}, {'value': '9', 'groupId': 'OG005'}]}, {'title': 'No Change', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '1', 'groupId': 'OG004'}, {'value': '5', 'groupId': 'OG005'}]}, {'title': 'Minimally Worse', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A, B, and C: Day 302', 'description': "The CGIC scale was a 7 point scale that required the clinician to assess how much the participant's illness had changed relative to a baseline state at the beginning of the intervention, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Higher rating indicates worsening of the condition. A separate CGIC assessment was performed by the Investigator (I) and caregiver (C). The categories with at least one participant having a CGIC score was reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analyzed' indicates the number of participants evaluable for the specified category."}, {'type': 'SECONDARY', 'title': 'Parts A, B and C: Number of Serious Respiratory Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '2', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 399', 'unitOfMeasure': 'number of events', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'SECONDARY', 'title': 'Part B Infantile-onset SMA: Percentage of Time on Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '100'}, {'value': '7.5', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '100'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline up to Day 302', 'unitOfMeasure': 'percentage of hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Parts A, B and C: Number of Participants With Ventilator Use', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}, {'value': '50', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}, {'value': '16', 'groupId': 'OG004'}, {'value': '40', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}, {'value': '4', 'groupId': 'OG003'}, {'value': '5', 'groupId': 'OG004'}, {'value': '8', 'groupId': 'OG005'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A, B, and C: Screening up to Day 302', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who received at least one dose of nusinersen in the current study.'}, {'type': 'SECONDARY', 'title': 'Part A: Change From Baseline in the Parent Assessment of Swallowing Ability (PASA) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}], 'classes': [{'title': 'Had Difficulty Feeding Themselves', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Had to Suction Excess Saliva/Drool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Not Able Eat as Much as Would Like', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Not Able Eat Food Variety Would Like', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Been Tube-Fed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Refused Liquid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty Drinking Thin Liquids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty Drinking Thick Liquids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Cough/Clear Throat Swallow Liquid Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Gagged or Choked on Liquid Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Retching/Vomiting Drinking Liquids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Taken > 30 Minutes Drink Liquids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Refused Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty Swallowing Soft Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Difficulty Swallowing Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Had Difficulty Swallowing Pills', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.98', 'groupId': 'OG000'}]}]}, {'title': 'Cough/Clear Throat Eat/Swallow Solid Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Had Food Stuck in Throat/Chest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Gagged/Choked on Their Solid Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Retching/Vomiting Eating Solids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.41', 'groupId': 'OG000'}]}]}, {'title': 'Required Food to Be Cut Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Experienced/Shown Pain When Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.00', 'groupId': 'OG000'}]}]}, {'title': 'Has Taken > 30 Minutes Eat Solids', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.52', 'groupId': 'OG000'}]}]}, {'title': "Concern Child's Swallowing Ability", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.72', 'groupId': 'OG000'}]}]}, {'title': "Concerned About Child's Weight", 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.60', 'groupId': 'OG000'}]}]}, {'title': 'Concern Variety Foods Child Eats', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Concern Child Not Able Eat as Much', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Concern Child Unable Eat Variety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.37', 'groupId': 'OG000'}]}]}, {'title': 'Concern Not Get Goodness From Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.17', 'groupId': 'OG000'}]}]}, {'title': 'Concerned Child Aspirating Food', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.55', 'groupId': 'OG000'}]}]}, {'title': 'Concern Child Choking When Eating', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '1.60', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains: general feeding, drinking liquids, eating solid foods, \\& assessment of swallowing concerns. Items in domains general feeding, drinking liquids, \\& eating solid foods are assessed with 5 levels of response scored as 4-Never, 3-Rarely, 2-Sometimes, 1-Often, \\& 0-Always. Domain for assessing swallowing concerns has 4 levels of responses scored as: 3-Strongly Disagree, 2-Disagree, 1-Agree, 0-Strongly Agree. Higher score= improvement. A negative change from baseline=decrease in swallowing ability. From domains \'drinking liquids\' and \'eating solid foods\', 2 items (attempted to drink liquids and eat solid foods) were assessed as "Yes"/"No", which are reported in another outcome measure.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen. 'Number analysed (n)' signifies the number of participants evaluable for the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part A: Number of Participants With Shift From Baseline in PASA Scale Items - Attempted to Drink Liquids and Attempted to Eat Solid Foods', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}], 'classes': [{'title': 'Attempted to Drink Liquid Foods', 'categories': [{'title': 'Baseline: No, Post-baseline: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: No, Post-baseline: No', 'measurements': [{'value': '2', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: Yes, Post-baseline: Yes', 'measurements': [{'value': '4', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: Yes, Post-baseline: No', 'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}]}, {'title': 'Attempted to Eat Solid Foods', 'categories': [{'title': 'Baseline: No, Post-baseline: Yes', 'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: No, Post-baseline: No', 'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: Yes, Post-baseline: Yes', 'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}, {'title': 'Baseline: Yes, Post-baseline: No', 'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '0.00'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains that cover general feeding, drinking liquids, eating solid foods, and assessment of swallowing concerns. The 2 items of domains drinking liquids (attempted to drink liquids), eating solid foods (attempted to eat solid foods) were assessed as "Yes"/"No". Data for the 2 items were summarized in terms of the shift from baseline.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Part B: Change From Baseline in the PASA Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'OG002', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG003', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'title': 'Had Difficulty Feeding Themselves', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.81', 'groupId': 'OG000'}, {'value': '-0.6', 'spread': '1.55', 'groupId': 'OG001'}, {'value': '-0.4', 'spread': '0.53', 'groupId': 'OG002'}, {'value': '0.3', 'spread': '0.73', 'groupId': 'OG003'}]}]}, {'title': 'Had To Suction Excess Saliva or Drool', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '1.38', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.58', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.38', 'groupId': 'OG002'}, {'value': '0.1', 'spread': '0.36', 'groupId': 'OG003'}]}]}, {'title': 'Not Able To Eat As Much As Would Like', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '1.45', 'groupId': 'OG001'}, {'value': '0.3', 'spread': '0.95', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.39', 'groupId': 'OG003'}]}]}, {'title': 'Not Able To Eat Food Variety They Like', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.6', 'spread': '1.72', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.18', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.69', 'groupId': 'OG002'}, {'value': '-0.4', 'spread': '0.93', 'groupId': 'OG003'}]}]}, {'title': 'Been Tube-Fed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}, {'value': '14', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '-1.8', 'spread': '2.11', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '1.76', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG002'}, {'value': '0.0', 'spread': '0.00', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains that cover general feeding, drinking liquids, eating solid foods, and assessment of swallowing concerns. Items in domains of general feeding, drinking liquids, \\& eating solid foods are assessed with 5 levels of response scored as 4-Never, 3-Rarely, 2-Sometimes, 1-Often, \\& 0-Always. Domain for assessing swallowing concerns has 4 levels of responses scored as: 3-Strongly Disagree, 2-Disagree, 1-Agree, 0-Strongly Agree. Higher score= improvement. A negative change from baseline=decrease in swallowing ability. As planned, for part B of the study, the PASA scale was assessed for the domain general feeding only.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who were randomized and received at least one dose of nusinersen. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)', signifies the number of participants evaluable for the specified parameter."}, {'type': 'SECONDARY', 'title': 'Part B: Infantile SMA-onset: Change From (Ratio to) Baseline in CSF Concentration of NF-L', 'denoms': [{'units': 'Participants', 'counts': [{'value': '25', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'OG001', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.06', 'groupId': 'OG000', 'lowerLimit': '0.05', 'upperLimit': '0.08'}, {'value': '0.05', 'groupId': 'OG001', 'lowerLimit': '0.04', 'upperLimit': '0.06'}]}]}], 'analyses': [{'pValue': '=0.3785', 'groupIds': ['OG000', 'OG001'], 'paramType': 'LS geometric mean ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.86', 'ciLowerLimit': '0.62', 'ciUpperLimit': '1.2', 'pValueComment': 'ANCOVA model was used with treatment as a fixed effect and adjusted for each participant disease duration at screening, baseline log CSF NF-L and baseline CHOP INTEND total score.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Baseline, Day 279', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.', 'unitOfMeasure': 'ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT set included all participants who were randomized and received at least one dose of nusinersen.'}, {'type': 'SECONDARY', 'title': 'Parts A and C: Change From Baseline in HFMSE Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.8', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'HFMSE scale was a tool used to assess motor function in children with SMA. The original 20 item Hammersmith Functional Motor Scale was expanded to include 13 additional adapted items from the Gross Motor Function Measure to improve sensitivity for the higher functioning ambulant population. Each item is scored 0 (unable), 1 (performs with modification or adaptation) or 2 (able) and the total score was calculated by summing the 33 items and ranged from 0 to 66 with higher scores indicating greater motor function. Negative change from baseline indicates decrease in motor function.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts A and C: Change From Baseline in RULM Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '1.52', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '2.14', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'RULM test was developed to assess upper limb functional abilities. RULM test: total 20 items. First item was assessed on 7-point scale (0:No useful function to 6-Can abduct both arms simultaneously, elbows in extension in full circle until they touch above head). This first item did not contribute to total score. For remaining 19 items, 18 items were assessed on 3-point scale: 0-Unable to achieve independently; 1-Modified method but achieves goal independent of physical assistance from another person; 2-Normal -achieves goal without any assistance. One remaining item was assessed as either 0 or 1. For each item, score was collected on left \\& right side. Derived total score=summing scores from these 19 individual items ranging from 0-if participant fails all activities to 37-if participant achieves all activities. If, for an individual item, response was recorded for both left \\& right side, highest score was used in calculating total score. Higher scores=increased upper limb function.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts A and C: Number of Participants With WHO Motor Milestones Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Gain of one or More Motor Milestones', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'No Change', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}, {'title': 'Loss of one or More Motor Milestones', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "The WHO motor milestones were a set of six milestones in motor development: sitting without support, standing with assistance, hands and knees crawling, walking with assistance, standing alone and walking alone. The examiner recorded an overall rating of the participant's emotional state and then for each milestone one of the following four classifications: no (inability) - child tried but failed to perform the milestone, no (refusal) - child refused to perform despite being calm and alert, yes - child was able to perform the milestone, unable to test - could not be tested because of irritability, drowsiness or sickness.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts A and C: Change From Baseline in ACEND Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'Feeding/Grooming/Dressing Total Score', 'categories': [{'measurements': [{'value': '0.6', 'spread': '2.51', 'groupId': 'OG000'}, {'value': '0.8', 'spread': '7.50', 'groupId': 'OG001'}]}]}, {'title': 'Sitting/Play Total Score', 'categories': [{'measurements': [{'value': '0.0', 'spread': '11.03', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '14.48', 'groupId': 'OG001'}]}]}, {'title': 'Transfers Total Score', 'categories': [{'measurements': [{'value': '-8.0', 'spread': '12.39', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '15.34', 'groupId': 'OG001'}]}]}, {'title': 'Mobility Total Score', 'categories': [{'measurements': [{'value': '7.1', 'spread': '13.85', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '15.01', 'groupId': 'OG001'}]}]}, {'title': 'Time Total Score', 'categories': [{'measurements': [{'value': '6.3', 'spread': '14.25', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Emotion Total Score', 'categories': [{'measurements': [{'value': '11.1', 'spread': '7.66', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '9.44', 'groupId': 'OG001'}]}]}, {'title': 'Finance Total Score', 'categories': [{'measurements': [{'value': '15.8', 'spread': '14.29', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '12.00', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'ACEND instrument was designed to quantify caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The ACEND included a total of seven domains assessing physical impact (including feeding/grooming/dressing, sitting/play, transfers, and mobility) and general caregiver impact (including time, emotion, and finance, and each domain comprised several items. The total score for each domain was calculated on a scale of 0 to 100, with a higher score indicating a decreased caregiver burden. A negative change from baseline indicates an increased caregiver burden.', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Parts A and C: Change From Baseline in PedsQL™ Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Part A: Nusinersen 28/28 mg', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen IT on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'OG001', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'title': 'PQLI-Total Score-Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '18.228', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '9.74', 'groupId': 'OG001'}]}]}, {'title': 'PQLI-Total Score-Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '12.51', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '8.15', 'groupId': 'OG001'}]}]}, {'title': 'PQLN-Total Score-Participant', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.9', 'spread': '6.94', 'groupId': 'OG000'}, {'value': '6.7', 'spread': '13.11', 'groupId': 'OG001'}]}]}, {'title': 'PQLN-Total Score-Parent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.7', 'spread': '5.72', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '9.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': "Participants were evaluated using PedsQL generic core scale \\& neuromuscular module. PedsQL generic core scale was used to calculate PedsQL inventory total score (PQLI), that included parent \\& participant's assessment on 4 dimensions: physical, emotional, social, \\& school functioning \\& psychosocial health. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). PedsQL neuromuscular module (PQLN) measured HRQOL dimensions specific to with neuromuscular disorders, like SMA. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). Dimensions were reversed scored \\& were linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) for both PQLI and PQLN, higher scores indicative of better health related quality of life. Total scale scores were calculated as sum of all items over number of items answered on all scales. If more than 50% of items/more within a dimension were missing, scale score was not computed.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure. 'Number analysed (n)' signifies number of participants evaluable for the specified total score."}, {'type': 'SECONDARY', 'title': 'Part C: Change From Baseline in CHOP-INTEND Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable SD was not estimable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score).', 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. It was planned to be assessed in infantile-onset SMA participants. 'Overall number of participants analyzed' signifies number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Part C: Change From Baseline in HINE Section 2 Motor Milestones Total Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.0', 'spread': 'NA', 'comment': 'Since only one participant was evaluable SD was not estimable.', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 302', 'description': "Section 2 of the HINE was used to assess motor milestones of the infantile-onset SMA participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. The 8 categories of HINE Section 2 can be summed to give a total score that ranges from 0 to 26.", 'unitOfMeasure': 'score on scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT set included all participants who received at least one dose of nusinersen in the current study. It was planned to be assessed in infantile-onset SMA participants. 'Overall number of participants analyzed' signifies number of participants evaluable for this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Part A: 28/28 Milligrams (mg) Nusinersen', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen, intrathecally (IT), on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'FG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'FG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'FG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen, IT, on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'FG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen, IT, on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'FG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen, IT, on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '25'}, {'groupId': 'FG002', 'numSubjects': '50'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '7'}, {'groupId': 'FG004', 'numSubjects': '16'}, {'groupId': 'FG005', 'numSubjects': '40'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '15'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Parent or Guardian', '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': 'Reason not Specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '1'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants took part in the study at the investigative sites in the United States, Brazil, Canada, Chile, China, Colombia, Estonia, Germany, Hungary, Italy, Japan, Lebanon, Mexico, Poland, Russia, Saudi Arabia, Spain, and Taiwan.', 'preAssignmentDetails': 'A total of 145 participants diagnosed with spinal muscular atrophy (SMA) were enrolled in the 3-parts (Parts A, B, and C). Of which, 117 of participants completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Part A: 28/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 3 loading doses of 28 mg of nusinersen, IT, on Days 1, 15 and 29 followed by 2 maintenance doses of 28 mg on Days 149 and 269.'}, {'id': 'BG001', 'title': 'Part B: Infantile-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with infantile-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen IT on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'BG002', 'title': 'Part B: Infantile-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with infantile-onset SMA received 2 loading doses of 50 mg of nusinersen IT on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'BG003', 'title': 'Part B: Later-Onset SMA: 12/12 mg Nusinersen', 'description': 'Participants with later-onset SMA in the control group received 4 loading doses of 12 mg of nusinersen IT on Days 1, 15, 29, and 64 followed by 2 maintenance doses of 12 mg on Days 183 and 279. Sham procedure was administered on Day 135.'}, {'id': 'BG004', 'title': 'Part B: Later-Onset SMA: 50/28 mg Nusinersen', 'description': 'Participants with later-onset SMA received 2 loading doses of 50 mg of nusinersen IT on Days 1 and 15 followed by 2 maintenance doses of 28 mg on Days 135 and 279. Sham procedure was administered on Days 29, 64 and 183.'}, {'id': 'BG005', 'title': 'Part C: 50/28 mg Nusinersen', 'description': 'Participants with infantile and later-onset SMA who had been receiving the approved dose of 12 mg for at least 1 year prior to entry, received a single bolus dose of 50 mg of nusinersen IT on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by 2 maintenance doses of 28 mg on Days 121 and 241.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Newborns (0-27 days)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}, {'title': 'Infants and toddlers (28 days - 23 months)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}, {'title': 'Children (2 - 11 years)', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '39', 'groupId': 'BG006'}]}, {'title': 'Adolescents (12 - 17 years)', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '7', 'groupId': 'BG006'}]}, {'title': 'Adults (18 - 64 years)', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '23', 'groupId': 'BG005'}, {'value': '23', 'groupId': 'BG006'}]}, {'title': 'From 65 - 84 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}, {'value': '15', 'groupId': 'BG005'}, {'value': '71', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '25', 'groupId': 'BG005'}, {'value': '74', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '5', 'groupId': 'BG005'}, {'value': '42', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}, {'value': '35', 'groupId': 'BG005'}, {'value': '99', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}, {'value': '40', 'groupId': 'BG005'}, {'value': '145', 'groupId': 'BG006'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '30', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '93', 'groupId': 'BG006'}]}, {'title': 'Not Reported Due to Confidentiality Regulations', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '17', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOPINTEND) Total Score", 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '75', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '19.9', 'spread': '9.63', 'groupId': 'BG001'}, {'value': '20.9', 'spread': '10.23', 'groupId': 'BG002'}, {'value': '20.6', 'spread': '9.98', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score)', 'unitOfMeasure': 'Score on scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'ITT set included all participants who received at least one dose of nusinersen. It was planned to be assessed in the infantile-SMA onset participants of Part B.'}], 'populationDescription': 'Part A: Safety set included all participants that received at least one dose of nusinersen. Part B: The intent-to-treat (ITT) set included all participants who were randomized and received at least one dose of nusinersen. Part C: ITT set included all participants who received at least one dose of nusinersen in the current study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-06-11', 'size': 5329656, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-02-20T03:19', 'hasProtocol': True}, {'date': '2024-07-19', 'size': 19515455, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-02-20T03:31', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 145}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2024-05-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-19', 'studyFirstSubmitDate': '2019-09-11', 'resultsFirstSubmitDate': '2025-02-20', 'studyFirstSubmitQcDate': '2019-09-12', 'lastUpdatePostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-19', 'studyFirstPostDateStruct': {'date': '2019-09-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-06-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'timeFrame': 'Baseline, Day 183', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score). The change from baseline to Day 183 in the CHOP-INTEND total score was compared to CS3B study (NCT02193074) sham control group using the joint-rank methodology to account for mortality.'}, {'measure': 'Parts A and C: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (TESAEs)', 'timeFrame': 'Part A: From the first dose of the study drug up to Day 389, Part C: From the first dose of the study drug up to Day 361', 'description': 'An adverse event (AE) was any unfavorable \\& unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with use of an investigational product, whether or not related to investigational product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of Investigator, placed participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AE and SAEs were regarded as treatment-emergent if it was present prior to receiving first dose of nusinersen in this current study and subsequently worsened in severity or was not present prior to receiving first dose of nusinersen and subsequently appeared.'}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Blood chemistry parameters included protein, albumin, creatinine, blood urea nitrogen, bilirubin (total and direct), alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium, potassium, cystatin C, and creatine kinase. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Hematology parameters included complete blood cell count, with differential and platelet count, and absolute neutrophil count. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline values. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Urinalysis', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "Urinalysis included assessments of urine total protein, specific gravity, pH, protein, glucose, ketones, bilirubin, blood, red blood cells (RBC), white blood cells (WBC), epithelial cells, bacteria, casts and crystals. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Cerebrospinal Fluid (CSF) Parameters', 'timeFrame': 'Part A: Baseline up to Day 269, Part C: Baseline up to Day 241', 'description': "CSF parameters included cell count, total protein, and glucose. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Electrocardiograms (ECGs)', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'The ECGs were assessed by the investigator to be normal, abnormal and abnormal AE. The number of participants with ECG shifts from normal to each of the categorical values denoting an abnormal scan (abnormal not AE, abnormal AE) was assessed. Shift from baseline to worst post-baseline values were reported. The categories with at least one participant with shift from baseline in ECG are reported.'}, {'measure': 'Parts A and C: Number of Participants With Abnormalities in Vital Sign Parameters', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'Vital sign assessment included temperature, pulse rate, systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \\< 36.0 and \\> 38.0 degrees Celsius (C), pulse rate \\< 60 and \\> 100 beats per minute (bpm), systolic blood pressure \\[\\< 90, \\> 140 and \\> 160 millimeters of mercury (mmHg)\\], diastolic blood pressure \\< 50, \\> 90 and \\> 100 mmHg and respiratory rate \\< 12 and \\> 20 breaths per minute. The categories with at least one participant with clinically relevant vital sign abnormalities are reported.'}, {'measure': 'Parts A and C: Change From Baseline in Growth Parameters (Body Height)', 'timeFrame': 'Parts A and C: Baseline, Day 302'}, {'measure': 'Part C: Change From Baseline in Growth Parameters (Head Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head circumference was measured for participants with infantile-onset SMA only.'}, {'measure': 'Part C: Change From Baseline in Growth Parameters (Chest Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in protocol, chest circumference was measured for participants with infantile-onset SMA only.'}, {'measure': 'Part C: Change From Baseline in Growth Parameters (Arm Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, arm circumference was measured for participants with infantile-onset SMA. Here, negative change from baseline indicated reduction in arm circumference.'}, {'measure': 'Parts A and C: Change From Baseline in Growth Parameters (Ulnar Length)', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'As pre-specified in the protocol, ulnar length was measured for participants with later-onset SMA.'}, {'measure': 'Parts A and C: Change From Baseline in Growth Parameters (Weight for Age Percentile)', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'World Health Organization (WHO) child growth standards (2006) was used to calculate the weight for age percentile in the infantile-onset participants while the 2000 Centers for Disease Control and Prevention (CDC) Growth Charts was used to calculate the weight for age percentile for later-onset participants. Negative change from baseline indicates low weight for age percentile.'}, {'measure': 'Part C: Change From Baseline in Growth Parameters (Weight for Length Ratio)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, weight for length ratio was assessed only for the participants with infantile-onset SMA.'}, {'measure': 'Part C: Change From Baseline in Growth Parameters (Head-to-Chest Circumference Ratio)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head to chest circumference ratio was assessed only for the participants with infantile-onset SMA.'}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Activated Partial Thromboplastin Time (aPTT))', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'Activated partial thromboplastin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of aPTT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of aPTT at baseline to high values postbaseline.'}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (Prothrombin Time (PT))', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'Prothrombin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of PT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of PT at baseline to high values postbaseline.'}, {'measure': 'Parts A and C: Number of Participants With Shifts From Baseline in Coagulation Parameters (International Normalized Ratio (INR))', 'timeFrame': 'Parts A and C: Baseline up to Day 269', 'description': 'INR was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of INR at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of INR at baseline to high values postbaseline. The category with at least one participant with shift from baseline in INR ratio is reported.'}, {'measure': 'Parts A and C: Change From Baseline in Urine Total Protein', 'timeFrame': 'Parts A and C: Baseline, Day 302'}, {'measure': 'Parts A and C: Number of Participants With Neurological Examination Abnormalities Reported as AEs', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': 'Participants with abnormalities in neurological examinations recorded as AEs were reported.'}, {'measure': 'Parts A and C: Percentage of Participants With a Postbaseline Platelet Count Below the Lower Limit of Normal on at Least 2 Consecutive Measurements', 'timeFrame': 'Parts A and C: Baseline up to Day 302'}, {'measure': "Parts A and C: Percentage of Participants With a Postbaseline Corrected QT Interval Using Fridericia's Formula (QTcF) of > 500 Millisecond (Msec) and an Increase From Baseline to Any Postbaseline Timepoint in QTcF of > 60 Msec", 'timeFrame': 'Parts A and C: Baseline up to Day 302'}], 'secondaryOutcomes': [{'measure': 'Part B Infantile-onset SMA: Percentage of Hammersmith Infant Neurological Examination (HINE) Section 2 Motor Milestone Responders for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group', 'timeFrame': 'Baseline, Day 183', 'description': "Section 2 of HINE was used to assess motor milestones of participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, \\& walking. Motor milestone responder: (i) a participant that demonstrated at least a 2-point increase in category of ability to kick or maximal score on that category or a 1-point increase in category of head control, rolling, sitting, crawling, standing, or walking, (ii) improvement in more categories than worsening, excluding category of voluntary grasp. For category of ability to kick, improvement, as defined in (i), worsening: at least a 2-point decrease or decrease to lowest possible score of no kicking. For other 6 categories, improvement: 1-point increase, worsening: at least 1-point decrease. Participants who died or withdrew from study were considered as non-responders. Difference in percentage of responders reported using Fisher's exact test."}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in HINE Section 2 Motor Milestones Total Score for Nusinersen 50/28mg Treatment Group Versus CS3B Matched Sham Control Group', 'timeFrame': 'Baseline, Day 183', 'description': "Section 2 of the HINE was used to assess motor milestones of the participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each category, 3 to 5 levels can be achieved. The total HINE section 2 motor milestones score was calculated as sum of each level \\& ranged from 0 to 26, higher score indicating improvement in motor milestones. A negative change from baseline indicates decline in motor milestones. Change from baseline in HINE section 2 motor milestones total score was compared to study CS3B (NCT02193074) matched sham control group, and was analysed using joint rank methodology."}, {'measure': 'Part B Infantile-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of Neurofilament Light Chain (NF-L) for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'timeFrame': 'Baseline, Day 183', 'description': 'The change from baseline in the plasma concentration of NF-L was compared to the study CS3B (NCT02193074) matched sham control group. Joint rank methodology was used for the analysis to account for mortality. The change from baseline data was reported in terms of least square geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.'}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in CHOP-INTEND Total Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score). The change from baseline to Day 302 in the total score was analyzed using the joint-rank methodology to account for mortality.'}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in HINE Section 2 Motor Milestones Total Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': "Section 2 of the HINE was used to assess motor milestones of the participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. The total motor milestones score for HINE section was calculated as the sum of each level and ranged from 0 to a maximum score of 26, higher score indicating improvement in motor milestones."}, {'measure': 'Part B Infantile-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 64', 'description': 'The change from baseline in plasma concentration of NF-L was analysed using the joint rank methodology to account for mortality. The change from baseline data was reported in terms of LS geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.'}, {'measure': 'Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'timeFrame': 'Screening up to Day 399', 'description': 'Permanent ventilation was defined as tracheostomy or ≥ 16 hours of ventilation/day continuously for \\> 21 days in absence of an acute reversible event. An independent endpoint adjudication committee (EAC) determined date at which a participant was considered to have met protocol-specified criteria of an acute reversible event. Only events that were adjudicated by the EAC as meeting the criteria for permanent ventilation or death were included in analysis. Participants who did not meet the endpoint definition were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.'}, {'measure': 'Part B Infantile-onset SMA: Time to Death (Overall Survival) for 50/28mg Nusinersen Versus CS3B Matched Sham Control Group', 'timeFrame': 'Screening up to Day 399', 'description': 'Time to death was determined by an independent EAC. Time to death (overall survival) was compared to the study CS3B (NCT02193074) matched sham control group.'}, {'measure': 'Part B Infantile-onset SMA: Time to Death or Permanent Ventilation for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Screening up to Day 399', 'description': 'Permanent ventilation was defined as tracheostomy or ≥ 16 hours of ventilation/day continuously for \\> 21 days in the absence of an acute reversible event. An independent EAC determined the date at which a participant was considered to have met the protocol-specified criteria of an acute reversible event. Only events that were adjudicated by the EAC as meeting the protocol defined criteria for permanent ventilation or death was included in the analysis. Participants who did not meet the endpoint definition were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.'}, {'measure': 'Part B Infantile-onset SMA: Time to Death (Overall Survival) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Screening up to Day 399', 'description': 'Time to death was determined by an independent EAC. Participants who did not die were censored on the last occasion the participant was seen (either in-person visit or by telephone contact), irrespective of whether the participant has completed the full course of treatment and whether the participant has completed the study or permanently withdrawn.'}, {'measure': 'Part B Later-onset SMA: Change From Baseline in Hammersmith Functional Motor Scale Expanded (HFMSE) Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': 'HFMSE scale was a tool used to assess motor function in children with later-onset SMA. The original 20 item Hammersmith Functional Motor Scale was expanded to include 13 additional adapted items from the Gross Motor Function Measure to improve sensitivity for the higher functioning ambulant population. Each item is scored 0 (unable), 1 (performs with modification or adaptation) or 2 (able) and the total score was calculated by summing the 33 items and ranged from 0 to 66 with higher scores indicating greater motor function.'}, {'measure': 'Part B Later-onset SMA: Change From Baseline in Revised Upper Limb Module (RULM) Score for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': 'RULM test was developed to assess upper limb functional abilities. RULM test: total 20 items. First item was assessed on 7-point scale (0:No useful function to 6-Can abduct both arms simultaneously, elbows in extension in full circle until they touch above head). This first item did not contribute to total score. For remaining 19 items, 18 items were assessed on 3-point scale: 0-Unable to achieve independently; 1-Modified method but achieves goal independent of physical assistance from another person; 2-Normal -achieves goal without any assistance. One remaining item was assessed as either 0 or 1. For each item, score was collected on left \\& right side. Derived total score=summing scores from these 19 individual items ranging from 0-if participant fails all activities to 37-if participant achieves all activities. If, for an individual item, response was recorded for both left \\& right side, highest score was used in calculating total score. Higher scores=increased upper limb function.'}, {'measure': 'Part B Later-onset SMA: Number of New World Health Organization (WHO) Motor Milestones Achieved Per Participant for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': "The WHO motor milestones were a set of six milestones in motor development: sitting without support, standing with assistance, hands and knees crawling, walking with assistance, standing alone and walking alone. The examiner recorded an overall rating of the participant's emotional state and then for each milestone one of the following four classifications: no (inability) - child tried but failed to perform the milestone, no (refusal) - child refused to perform despite being calm and alert, yes - child was able to perform the milestone, unable to test - could not be tested because of irritability, drowsiness or sickness. Mean of number of new milestones achieved per participant was calculated and reported in this outcome measure."}, {'measure': 'Part B Later-onset SMA: Change From Baseline in Assessment of Caregiver Experience With Neuromuscular Disease (ACEND) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': 'ACEND instrument was designed to quantify caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The ACEND included a total of seven domains assessing physical impact (including feeding/grooming/dressing, sitting/play, transfers, and mobility) and general caregiver impact (including time, emotion, and finance, and each domain comprised several items. The total score for each domain was calculated on a scale of 0 to 100, with a higher score indicating a decreased caregiver burden. A negative change from baseline indicates an increased caregiver burden.'}, {'measure': 'Part B Later-onset SMA: Change From Baseline in Pediatric Quality of Life Inventory™ (PedsQL) for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': "Participants were evaluated using PedsQL generic core scale \\& neuromuscular module. PedsQL generic core scale was used to calculate PedsQL inventory total score (PQLI), that included parent \\& participant's assessment on 4 dimensions: physical, emotional, social, \\& school functioning \\& psychosocial health. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). PedsQL neuromuscular module (PQLN) measured HRQOL dimensions specific to with neuromuscular disorders, like SMA. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). Dimensions were reversed scored \\& were linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) for both PQLI and PQLN, higher scores indicative of better health related quality of life. Total scale scores were calculated as sum of all items over number of items answered on all scales. If more than 50% of items/more within a dimension were missing, scale score was not computed."}, {'measure': 'Part B Later-onset SMA: Change From (Ratio to) Baseline in CSF Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 279', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.'}, {'measure': 'Part B Later-onset SMA: Change From (Ratio to) Baseline in Plasma Concentration of NF-L for 50/28mg Nusinersen Versus 12/12mg Nusinersen', 'timeFrame': 'Baseline, Day 302', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.'}, {'measure': 'Part B: Number of Participants With TEAEs and TESAEs', 'timeFrame': 'From the first dose of the study drug up to Day 399', 'description': 'AE was any unfavorable and unintended sign (including an abnormal assessment such as an abnormal laboratory value), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. An SAE was any untoward medical occurrence that at any dose resulted in death, in the view of the Investigator, placed the participant at immediate risk of death, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, resulted in a birth defect. AE was regarded as treatment-emergent if it was present prior to receiving the first dose of nusinersen in the current study and subsequently worsened in severity or was not present prior to receiving the first dose of nusinersen and subsequently appeared.'}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Hematology Parameters)', 'timeFrame': 'Baseline up to Day 302', 'description': "Hematology parameters included complete blood cell count, with differential and platelet count, and absolute neutrophil count. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Clinical Laboratory Parameters (Blood Chemistry Parameters)', 'timeFrame': 'Baseline up to Day 302', 'description': "Blood chemistry parameters included protein, albumin, creatinine, blood urea nitrogen, bilirubin (total and direct), alkaline phosphatase, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, glucose, calcium, phosphorus, bicarbonate, chloride, sodium, potassium, cystatin C, and creatine kinase. Parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. Categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Urinalysis', 'timeFrame': 'Baseline up to Day 302', 'description': "Urinalysis included assessments of urine total protein, specific gravity, pH, protein, glucose, ketones, bilirubin, blood, RBC , WBC, epithelial cells, bacteria, casts and crystals. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high, positive, abnormal or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, negative, absent, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in CSF Parameters', 'timeFrame': 'Baseline up to Day 302', 'description': "CSF parameters included cell count, total protein, and glucose. These parameters were flagged as low, normal, or high relative to parameter's normal range or as unknown if no result was available, by the Investigator. Here, shift to low indicates values that were normal, high or unknown at baseline and shifted to low values postbaseline. Shift to high indicates values that were normal, low or unknown at baseline and shifted to high values postbaseline. The categories with at least one participant with shift from baseline in these parameters are reported."}, {'measure': 'Part B: Number of Participants With Shift From Baseline in ECGs', 'timeFrame': 'Baseline up to Day 302', 'description': 'The ECGs were assessed by the investigator to be normal, abnormal and abnormal AE. The number of participants with ECG shifts from normal to each of the categorical values denoting an abnormal scan (abnormal not AE, abnormal AE) was assessed. Shift from baseline to worst post-baseline values were reported. The categories with at least one participant with shift from baseline in ECG are reported.'}, {'measure': 'Part B: Number of Participants With Abnormalities in Vital Sign Parameters', 'timeFrame': 'Baseline up to Day 302', 'description': 'Vital sign assessment included temperature, pulse rate systolic blood pressure, diastolic blood pressure, and respiratory rate. As pre-specified in protocol, the criteria for determining potentially clinically relevant abnormalities in vital signs included: temperature \\< 36.0 and \\> 38.0 degrees C, pulse rate \\< 60 and \\> 100 bpm, systolic blood pressure \\< 90, \\> 140 and \\> 160 mmHg, diastolic blood pressure \\< 50, \\> 90 and \\> 100 mmHg and respiratory rate \\< 12 and \\> 20 breaths per minute. The categories with at least one participant with clinically relevant vital sign abnormalities are reported.'}, {'measure': 'Part B: Change From Baseline in Growth Parameters (Body Height)', 'timeFrame': 'Baseline, Day 302', 'description': 'Body height was measured for all participants (infantile-onset and later-onset SMA).'}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Head Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'Head circumference was measured in participants with infantile-onset SMA.'}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Chest Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'Chest circumference was measured in participants with infantile-onset SMA.'}, {'measure': 'Part B Infantile-onset SMA: Change From Baseline in Growth Parameters (Arm Circumference)', 'timeFrame': 'Baseline, Day 302', 'description': 'Arm circumference was measured in participants with infantile-onset SMA.'}, {'measure': 'Part B: Change From Baseline in Growth Parameters (Ulnar Length)', 'timeFrame': 'Baseline, Day 302', 'description': 'Ulnar length was measured in participants with later-onset SMA.'}, {'measure': 'Part B: Change From Baseline in Growth Parameters (Weight for Age Percentile)', 'timeFrame': 'Baseline, Day 302', 'description': 'WHO child growth standards (2006) was used to calculate the weight for age percentile in the infantile-onset participants. The 2000 CDC Growth Charts was used to calculate the weight for age percentile for later-onset participants. Negative change from baseline indicates reduction in weight for age percentile'}, {'measure': 'Part B: Change From Baseline in Growth Parameters (Weight for Length Percentile)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, weight for length percentile was assessed only for the participants with infantile-onset SMA. Negative change from baseline indicates reduction in weight for length percentile.'}, {'measure': 'Part B: Change From Baseline in Growth Parameters (Head-to-Chest Circumference Ratio)', 'timeFrame': 'Baseline, Day 302', 'description': 'As pre-specified in the protocol, head to chest circumference ratio was assessed only for the participants with infantile-onset SMA. Negative change from baseline indicates reduction in head-to-chest circumference ratio.'}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (aPTT)', 'timeFrame': 'Baseline up to Day 279', 'description': 'aPTT was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of aPTT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of aPTT at baseline to high values postbaseline.'}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (PT)', 'timeFrame': 'Baseline up to Day 279', 'description': 'Prothrombin time was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of PT at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of PT at baseline to high values postbaseline.'}, {'measure': 'Part B: Number of Participants With Shifts From Baseline in Coagulation Parameters (INR)', 'timeFrame': 'Baseline up to Day 279', 'description': 'INR was evaluated to assess safety. "Shift to low" measured change in normal, high and unknown values of INR at baseline to low values postbaseline. "Shift to high" measured change in normal, low and unknown values of INR at baseline to high values postbaseline.'}, {'measure': 'Part B: Change From Baseline in Urine Total Protein', 'timeFrame': 'Baseline, Day 302'}, {'measure': 'Part B: Number of Participants With Neurological Examination Abnormalities Reported as AEs', 'timeFrame': 'Baseline up to Day 302', 'description': 'Participants with abnormalities in neurological examinations recorded as AEs were reported.'}, {'measure': 'Part B: Percentage of Participants With a Postbaseline Platelet Count Below the Lower Limit of Normal on at Least 2 Consecutive Measurements', 'timeFrame': 'Baseline up to Day 302'}, {'measure': 'Part B: Percentage of Participants With a Postbaseline QTcF of > 500 Msec and an Increase From Baseline to Any Postbaseline Timepoint in QTcF of > 60 Msec', 'timeFrame': 'Baseline up to Day 302'}, {'measure': 'Parts A, B and C: Number of Participants With Hospitalizations', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 302'}, {'measure': 'Parts A, B and C: Percentage of Time of Hospitalization', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 302'}, {'measure': 'Parts A, B and C: Number of Participants With Clinical Global Impression of Change (CGIC)', 'timeFrame': 'Parts A, B, and C: Day 302', 'description': "The CGIC scale was a 7 point scale that required the clinician to assess how much the participant's illness had changed relative to a baseline state at the beginning of the intervention, where 1=very much improved, 2=much improved, 3=minimally improved, 4=no change, 5=minimally worse, 6=much worse, 7=very much worse. Higher rating indicates worsening of the condition. A separate CGIC assessment was performed by the Investigator (I) and caregiver (C). The categories with at least one participant having a CGIC score was reported."}, {'measure': 'Parts A, B and C: Number of Serious Respiratory Events', 'timeFrame': 'Parts A, B, and C: Baseline up to Day 399'}, {'measure': 'Part B Infantile-onset SMA: Percentage of Time on Ventilation', 'timeFrame': 'Baseline up to Day 302'}, {'measure': 'Parts A, B and C: Number of Participants With Ventilator Use', 'timeFrame': 'Parts A, B, and C: Screening up to Day 302'}, {'measure': 'Part A: Change From Baseline in the Parent Assessment of Swallowing Ability (PASA) Scale', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains: general feeding, drinking liquids, eating solid foods, \\& assessment of swallowing concerns. Items in domains general feeding, drinking liquids, \\& eating solid foods are assessed with 5 levels of response scored as 4-Never, 3-Rarely, 2-Sometimes, 1-Often, \\& 0-Always. Domain for assessing swallowing concerns has 4 levels of responses scored as: 3-Strongly Disagree, 2-Disagree, 1-Agree, 0-Strongly Agree. Higher score= improvement. A negative change from baseline=decrease in swallowing ability. From domains \'drinking liquids\' and \'eating solid foods\', 2 items (attempted to drink liquids and eat solid foods) were assessed as "Yes"/"No", which are reported in another outcome measure.'}, {'measure': 'Part A: Number of Participants With Shift From Baseline in PASA Scale Items - Attempted to Drink Liquids and Attempted to Eat Solid Foods', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains that cover general feeding, drinking liquids, eating solid foods, and assessment of swallowing concerns. The 2 items of domains drinking liquids (attempted to drink liquids), eating solid foods (attempted to eat solid foods) were assessed as "Yes"/"No". Data for the 2 items were summarized in terms of the shift from baseline.'}, {'measure': 'Part B: Change From Baseline in the PASA Scale', 'timeFrame': 'Baseline, Day 302', 'description': 'PASA was assessed using a questionnaire. Caregivers were asked a series of questions regarding the mealtime behavior of the participant. The PASA questionnaire was developed to assess the signs and symptoms of dysphagia. It included 33 items across 4 domains that cover general feeding, drinking liquids, eating solid foods, and assessment of swallowing concerns. Items in domains of general feeding, drinking liquids, \\& eating solid foods are assessed with 5 levels of response scored as 4-Never, 3-Rarely, 2-Sometimes, 1-Often, \\& 0-Always. Domain for assessing swallowing concerns has 4 levels of responses scored as: 3-Strongly Disagree, 2-Disagree, 1-Agree, 0-Strongly Agree. Higher score= improvement. A negative change from baseline=decrease in swallowing ability. As planned, for part B of the study, the PASA scale was assessed for the domain general feeding only.'}, {'measure': 'Part B: Infantile SMA-onset: Change From (Ratio to) Baseline in CSF Concentration of NF-L', 'timeFrame': 'Baseline, Day 279', 'description': 'The change from baseline data was reported in terms of geometric mean ratio to baseline. Lower ratios to baseline represent greater reductions in concentrations of NF-L from baseline.'}, {'measure': 'Parts A and C: Change From Baseline in HFMSE Total Score', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'HFMSE scale was a tool used to assess motor function in children with SMA. The original 20 item Hammersmith Functional Motor Scale was expanded to include 13 additional adapted items from the Gross Motor Function Measure to improve sensitivity for the higher functioning ambulant population. Each item is scored 0 (unable), 1 (performs with modification or adaptation) or 2 (able) and the total score was calculated by summing the 33 items and ranged from 0 to 66 with higher scores indicating greater motor function. Negative change from baseline indicates decrease in motor function.'}, {'measure': 'Parts A and C: Change From Baseline in RULM Total Score', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'RULM test was developed to assess upper limb functional abilities. RULM test: total 20 items. First item was assessed on 7-point scale (0:No useful function to 6-Can abduct both arms simultaneously, elbows in extension in full circle until they touch above head). This first item did not contribute to total score. For remaining 19 items, 18 items were assessed on 3-point scale: 0-Unable to achieve independently; 1-Modified method but achieves goal independent of physical assistance from another person; 2-Normal -achieves goal without any assistance. One remaining item was assessed as either 0 or 1. For each item, score was collected on left \\& right side. Derived total score=summing scores from these 19 individual items ranging from 0-if participant fails all activities to 37-if participant achieves all activities. If, for an individual item, response was recorded for both left \\& right side, highest score was used in calculating total score. Higher scores=increased upper limb function.'}, {'measure': 'Parts A and C: Number of Participants With WHO Motor Milestones Status', 'timeFrame': 'Parts A and C: Baseline up to Day 302', 'description': "The WHO motor milestones were a set of six milestones in motor development: sitting without support, standing with assistance, hands and knees crawling, walking with assistance, standing alone and walking alone. The examiner recorded an overall rating of the participant's emotional state and then for each milestone one of the following four classifications: no (inability) - child tried but failed to perform the milestone, no (refusal) - child refused to perform despite being calm and alert, yes - child was able to perform the milestone, unable to test - could not be tested because of irritability, drowsiness or sickness."}, {'measure': 'Parts A and C: Change From Baseline in ACEND Total Score', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': 'ACEND instrument was designed to quantify caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The ACEND included a total of seven domains assessing physical impact (including feeding/grooming/dressing, sitting/play, transfers, and mobility) and general caregiver impact (including time, emotion, and finance, and each domain comprised several items. The total score for each domain was calculated on a scale of 0 to 100, with a higher score indicating a decreased caregiver burden. A negative change from baseline indicates an increased caregiver burden.'}, {'measure': 'Parts A and C: Change From Baseline in PedsQL™ Total Score', 'timeFrame': 'Parts A and C: Baseline, Day 302', 'description': "Participants were evaluated using PedsQL generic core scale \\& neuromuscular module. PedsQL generic core scale was used to calculate PedsQL inventory total score (PQLI), that included parent \\& participant's assessment on 4 dimensions: physical, emotional, social, \\& school functioning \\& psychosocial health. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). PedsQL neuromuscular module (PQLN) measured HRQOL dimensions specific to with neuromuscular disorders, like SMA. Each item was scored on 5-point ordinal scale (0=never to 4=almost always). Dimensions were reversed scored \\& were linearly transformed to 0-100 scale (0=100, 1=75, 2=50, 3=25, 4=0) for both PQLI and PQLN, higher scores indicative of better health related quality of life. Total scale scores were calculated as sum of all items over number of items answered on all scales. If more than 50% of items/more within a dimension were missing, scale score was not computed."}, {'measure': 'Part C: Change From Baseline in CHOP-INTEND Total Score', 'timeFrame': 'Baseline, Day 302', 'description': 'The CHOP-INTEND test was designed to evaluate the motor skills of infants with significant motor weakness. It included 16 items (capturing neck, trunk, and proximal and distal limb strength), nine of which were scored 0, 1, 2, 3, or 4, five were scored as 0, 2, or 4, one was scored as 0, 1, 2, or 4, and one as 0, 2, 3, or 4 with higher scores indicating greater muscle strength and function. Total score was calculated as the sum of scores for each item. Total score ranged from 0 (worst possible score) and 64 (best possible score).'}, {'measure': 'Part C: Change From Baseline in HINE Section 2 Motor Milestones Total Score', 'timeFrame': 'Baseline, Day 302', 'description': "Section 2 of the HINE was used to assess motor milestones of the infantile-onset SMA participants. It's composed of 8 motor milestone categories: voluntary grasp, ability to kick in supine position, head control, rolling, sitting, crawling, standing, and walking. Within each of these categories, participants can progress from complete absence of a motor ability (the lowest level in each category) through multiple milestones (2 to 4 levels in each category) to the highest level within the category. The 8 categories of HINE Section 2 can be summed to give a total score that ranges from 0 to 26."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Muscular Atrophy, Spinal']}, 'referencesModule': {'references': [{'pmid': '35567345', 'type': 'DERIVED', 'citation': 'Finkel RS, Ryan MM, Pascual Pascual SI, Day JW, Mercuri E, De Vivo DC, Foster R, Montes J, Gurgel-Giannetti J, MacCannell D, Berger Z. Scientific rationale for a higher dose of nusinersen. Ann Clin Transl Neurol. 2022 Jun;9(6):819-829. doi: 10.1002/acn3.51562. Epub 2022 May 13.'}], 'seeAlsoLinks': [{'url': 'http://www.sma-europe.eu/', 'label': 'SMA Europe'}, {'url': 'http://www.curesma.org/', 'label': 'CureSMA'}, {'url': 'http://www.mda.org/disease/spinal-muscular-atrophy', 'label': 'Muscular Dystrophy Association'}, {'url': 'https://www.biogentriallink.com/en-us/home.html', 'label': 'Study website - US patients only'}]}, 'descriptionModule': {'briefSummary': "The primary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with spinal muscular atrophy (SMA), as measured by change in Children's Hospital of Philadelphia-Infant Test of Neuromuscular Disorders (CHOP-INTEND) total score (Part B); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C).\n\nThe secondary objectives of this study are to examine the clinical efficacy of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A, B and C); to examine the effect of nusinersen administered intrathecally at higher doses to participants with SMA (Parts A and C); to examine the safety and tolerability of nusinersen administered intrathecally at higher doses to participants with SMA, to examine the effect of nusinersen administered intrathecally at higher doses compared to the currently approved dose in participants with SMA (Part B)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Days', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\nPart A, B and C:\n\n\\- Genetic documentation of 5q SMA (homozygous gene deletion, mutation, or compound heterozygote)\n\nPart A:\n\n* Onset of clinical signs and symptoms consistent with SMA at \\> 6 months (\\> 180 days) of age (i.e., later-onset SMA)\n* Age 2 to ≤ 15 years, inclusive, at the time of informed consent\n\nPart B:\n\n* Participants with SMA symptom onset ≤ 6 months (≤ 180 days) of age (infantile onset) should have age \\> 1 week to ≤ 7 months (≤ 210 days) at the time of informed consent\n* Participants with SMA symptom onset \\> 6 months (\\> 180 days) of age (later onset):\n\n * Age 2 to \\< 10 years at the time of informed consent\n * Can sit independently but has never had the ability to walk independently\n * HFMSE score ≥ 10 and ≤ 54 at Screening\n\nPart C:\n\n\\- Currently on nusinersen treatment at the time of Screening, with the first dose being at least 1 year prior to Screening\n\nPart C Cohort 1:\n\n\\- Participants of any age (individuals ≥18 years of age at Screening must be ambulatory)\n\nPart C Cohort 2:\n\n* Participants ≥18 years of age at Screening (can be ambulatory or nonambulatory)\n* HFMSE total score ≥4 points at Screening\n* RULM entry item A score ≥3 points at Screening\n\nKey Exclusion Criteria:\n\nPart A, B and C:\n\n* Presence of an untreated or inadequately treated active infection requiring systemic antiviral or antimicrobial therapy at any time during the Screening period\n* Presence of an implanted shunt for the drainage of cerebrospinal fluid (CSF) or of an implanted central nervous system (CNS) catheter\n* Hospitalization for surgery, pulmonary event, or nutritional support within 2 months prior to Screening or planned within 12 months after the participant's first dose\n\nPart A:\n\n* Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for \\> 6 hours during a 24-hour period, at Screening\n* Medical necessity for a gastric feeding tube\n* Treatment with an investigational drug given for the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any survival motor neuron-2 gene (SMN2)-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation\n\nPart B:\n\n* Treatment with an investigational drug including but not limited to the treatment of SMA, biological agent, or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening or anytime during the study; any prior or current treatment with any SMN2-splicing modifier or gene therapy; or prior antisense oligonucleotide treatment, or cell transplantation\n* Participants with SMA symptom onset \\> 6 months (\\> 180 days) of age (later onset):\n\n * Respiratory insufficiency, defined by the medical necessity for invasive or noninvasive ventilation for \\> 6 hours during a 24-hour period, at Screening\n * Medical necessity for a gastric feeding tube\n* Participants with SMA symptom onset ≤ 6 months (≤ 180 days) of age (infantile onset): Signs or symptoms of SMA present at birth or within the first week after birth\n\nPart C:\n\n* Concurrent or previous participation and/or administration of nusinersen in another clinical study\n* Concomitant or previous administration of any SMN2-splicing modifier (excluding nusinersen) or gene therapy, either in a clinical study or as part of medical care.\n* Concurrent or previous participation in any interventional investigational study for any other drug or device within 30 days or 5 half-lives of the agent, whichever is longer, prior to Screening\n\nNOTE: Other protocol defined Inclusion/Exclusion criteria may apply."}, 'identificationModule': {'nctId': 'NCT04089566', 'acronym': 'DEVOTE', 'briefTitle': 'Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biogen'}, 'officialTitle': 'Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy', 'orgStudyIdInfo': {'id': '232SM203'}, 'secondaryIdInfos': [{'id': '2019-002663-10', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '28/28 Milligram (mg) Safety Group', 'description': 'Part A: Participants with later-onset SMA will receive loading doses of 28 mg of nusinersen intrathecally on Days 1, 15 and 29 followed by maintenance doses of 28 mg on Days 149 and 269.', 'interventionNames': ['Drug: Nusinersen']}, {'type': 'ACTIVE_COMPARATOR', 'label': '12/12 mg Active Control Group', 'description': 'Part B: Participants with infantile- or later-onset SMA will receive loading doses of 12 mg of nusinersen intrathecally on Days 1, 15, 29, and 64 followed by maintenance doses of 12 mg on Days 183 and 279. Sham procedure will be administered on Day 135.', 'interventionNames': ['Drug: Nusinersen']}, {'type': 'EXPERIMENTAL', 'label': '50/28 mg Active Treatment Group', 'description': 'Part B: Participants with infantile- or later-onset SMA will receive loading doses of 50 mg of nusinersen intrathecally on Days 1 and 15 followed by maintenance doses of 28 mg on Days 135 and 279. Sham procedure will be administered on Days 29, 64 and 183.', 'interventionNames': ['Drug: Nusinersen']}, {'type': 'EXPERIMENTAL', 'label': '12/50/28 mg Titration Group', 'description': 'Part C: Participants who have been receiving the approved dose of 12 mg for at least 1 year prior to entry, will receive a single bolus dose of 50 mg of nusinersen intrathecally on Day 1 (4 months after their most recent maintenance dose of 12 mg) followed by maintenance doses of 28 mg on Days 121 and 241.', 'interventionNames': ['Drug: Nusinersen']}], 'interventions': [{'name': 'Nusinersen', 'type': 'DRUG', 'otherNames': ['BIIB058'], 'description': 'Administered as specified in the treatment arm', 'armGroupLabels': ['12/12 mg Active Control Group', '12/50/28 mg Titration Group', '28/28 Milligram (mg) Safety Group', '50/28 mg Active Treatment Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94304', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Stanford Hospital and Clinics', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann & Robert H. Lurie Children's Hospital of Chicago", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '38105', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': "St. Jude Children's Research Hospital", 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '30130-100', 'city': 'Belo Horizonte', 'state': 'Minas Gerais', 'country': 'Brazil', 'facility': 'HC-UFMG - Hospital das Clinicas da Universidade Federal de Minas Gerais', 'geoPoint': {'lat': -19.92083, 'lon': -43.93778}}, {'zip': '90035-903', 'city': 'Porto Alegre', 'state': 'Rio Grande do Sul', 'country': 'Brazil', 'facility': 'Hospital de Clínicas de Porto Alegre', 'geoPoint': {'lat': -30.03283, 'lon': -51.23019}}, {'zip': '05403-000', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Hospital das Clínicas da Faculdade de Medicina da USP', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}, {'zip': 'N6A 5W9', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': "London Health Sciences Centre (LHSC) - 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