Viewing Study NCT02510261

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Ignite Creation Date: 2025-12-24 @ 12:45 PM
Ignite Modification Date: 2025-12-27 @ 4:07 PM
Study NCT ID: NCT02510261
Status: COMPLETED
Last Update Posted: 2023-12-06
First Post: 2015-07-16
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], 'ancestors': [{'id': 'D057165', 'term': 'Proteostasis Deficiencies'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000606954', 'term': 'patisiran'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Clinicaltrials@alnylam.com', 'phone': '866-330-0326', 'title': 'Chief Medical Officer', 'organization': 'Alnylam Pharmaceuticals Inc'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'First dose up to 28 days after last dose of study drug (approximately 5.6 years)', 'description': 'Safety analysis set included all the enrolled participants who received at least 1 dose of patisiran in this study.', 'eventGroups': [{'id': 'EG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.', 'otherNumAtRisk': 49, 'deathsNumAtRisk': 49, 'otherNumAffected': 47, 'seriousNumAtRisk': 49, 'deathsNumAffected': 19, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.', 'otherNumAtRisk': 137, 'deathsNumAtRisk': 137, 'otherNumAffected': 135, 'seriousNumAtRisk': 137, 'deathsNumAffected': 21, 'seriousNumAffected': 82}, {'id': 'EG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.', 'otherNumAtRisk': 25, 'deathsNumAtRisk': 25, 'otherNumAffected': 25, 'seriousNumAtRisk': 25, 'deathsNumAffected': 1, 'seriousNumAffected': 12}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial Flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ear Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Visual Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 22}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gait Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 35}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Peripheral Swelling', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infusion Related Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Erysipelas', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fungal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Infected Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Localised Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 8}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tonsillitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 21}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 28}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Wound Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Contusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 33}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Foot Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ligament Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Limb Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 6}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Post-traumatic Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin Abrasion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 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{'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Epistaxis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypoventilation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pulmonary Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory Acidosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory Arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Respiratory Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Sleep Apnoea Syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decubitus Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Skin Ulcer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Disability', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rehabilitation Therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Social circumstances', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypovolaemic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Neurogenic Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Phlebitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Poor Peripheral Circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Shock Haemorrhagic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Varicose Vein', 'stats': [{'groupId': 'EG000', 'numAtRisk': 49, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 137, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 25, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Adverse Events (AEs) Leading to Study Discontinuation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'groupId': 'OG000'}, {'value': '16.8', 'groupId': 'OG001'}, {'value': '0.0', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'First dose up to 28 days after last dose of study drug (approximately 5.6 years)', 'description': 'AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all the enrolled participants who received at least 1 dose of patisiran in this study. Percentages are rounded off to the nearest decimal point.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Neuropathy Impairment Score (NIS) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '81.47', 'spread': '41.674', 'groupId': 'OG000'}, {'value': '62.26', 'spread': '37.875', 'groupId': 'OG001'}, {'value': '35.48', 'spread': '28.686', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.45', 'spread': '16.566', 'groupId': 'OG000'}, {'value': '10.72', 'spread': '13.654', 'groupId': 'OG001'}, {'value': '11.18', 'spread': '17.554', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The NIS assessment is a 244-point composite measure of neurologic impairment which includes a physical exam of lower limbs, upper limbs, and cranial nerves to assess the components: motor strength/weakness (NIS-W), reflexes (NIS-R), and sensation (NIS-S). NIS total score is obtained by combining all the component scores, ranging from 0 to 244. Higher scores represent a greater severity of disease. A positive change from baseline indicates the worsening of neuropathy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Total Modified NIS (mNIS +7) Composite Score At Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '101.07', 'spread': '43.774', 'groupId': 'OG000'}, {'value': '74.72', 'spread': '42.584', 'groupId': 'OG001'}, {'value': '45.66', 'spread': '31.640', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.69', 'spread': '3.389', 'groupId': 'OG000'}, {'value': '8.07', 'spread': '1.874', 'groupId': 'OG001'}, {'value': '5.46', 'spread': '2.450', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 3', 'description': 'The mNIS+7 is a composite measure of neurologic impairment which includes the following components: physical exam of lower limbs, upper limbs, and cranial nerves to assess motor strength/weakness (192 points), reflexes (20 points), electrophysiologic measurement of small and large nerve fiber function (10 points), sensory testing (80 points), and postural blood pressure (2 points). The total mNIS+7 composite score is obtained by combining all the component scores, ranging from 0 (no impairment) to 304 (maximum impairment). A negative change from baseline indicates an improvement in neuropathy.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the NIS+7 Total Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '98.42', 'spread': '42.281', 'groupId': 'OG000'}, {'value': '78.74', 'spread': '39.417', 'groupId': 'OG001'}, {'value': '49.66', 'spread': '31.319', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.44', 'spread': '2.061', 'groupId': 'OG000'}, {'value': '1.49', 'spread': '0.894', 'groupId': 'OG001'}, {'value': '3.23', 'spread': '2.616', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'The NIS+7 provides additional, objective measures of nerve fibre function and autonomic nerve function in participants with diabetic neuropathy. The NIS+7 includes the full NIS, sum of 5 nerve conduction studies (NCS) (Sural sensory nerve action potential \\[SNAP\\], tibial motor nerve distal latency, peroneal compound motor action potential \\[CMAP\\], motor nerve conduction velocity, motor nerve distal latency), vibration detection threshold, and pulse rate response to deep breathing. The total NIS+7 score is obtained by combining all the component scores, ranging from 0 (no impairment) to 270 points (maximum impairment). A positive change from baseline indicates worsening.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Total Score at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '72.7', 'spread': '28.10', 'groupId': 'OG000'}, {'value': '54.5', 'spread': '30.87', 'groupId': 'OG001'}, {'value': '34.0', 'spread': 'NA', 'comment': 'Standard deviation (SD) cannot be estimated for one participant.', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '13.91', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '17.19', 'groupId': 'OG001'}, {'value': '-18.0', 'spread': 'NA', 'comment': 'Standard deviation (SD) cannot be estimated for one participant.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The Norfolk QoL-DN questionnaire is a standardized 47-item patient-reported outcomes measure, sensitive to the perception of the effects of diabetic neuropathy by the participant. The scores range from -4 (best possible QOL) to 136 (worst possible QOL). A negative change from baseline represents improved QOL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EuroQOL-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4614', 'spread': '0.03347', 'groupId': 'OG000'}, {'value': '0.6444', 'spread': '0.01856', 'groupId': 'OG001'}, {'value': '0.7663', 'spread': '0.03336', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0361', 'spread': '0.04017', 'groupId': 'OG000'}, {'value': '-0.0548', 'spread': '0.01767', 'groupId': 'OG001'}, {'value': '-0.0166', 'spread': '0.02363', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The EQ-5D-5L is a patient-reported measure of QoL based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The overall score is rated on a scale from 0 (worst) to 1 (no impairment). Higher scores indicate a higher QoL. A negative change from baseline indicates worsening of QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '46.0', 'spread': '2.86', 'groupId': 'OG000'}, {'value': '57.8', 'spread': '1.82', 'groupId': 'OG001'}, {'value': '69.1', 'spread': '4.20', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.3', 'spread': '5.03', 'groupId': 'OG000'}, {'value': '-1.5', 'spread': '1.43', 'groupId': 'OG001'}, {'value': '1.5', 'spread': '2.99', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'EQ-VAS measures the participant\'s self-rated health on a vertical scale evaluated on a scale of 0 ("worst health you can imagine") to 100 ("best health you can imagine"). Higher scores indicate a higher QOL. A negative change from baseline indicates worsening of QoL.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Composite Autonomic Symptom Score (COMPASS 31) Total Score at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '33.92', 'spread': '18.185', 'groupId': 'OG000'}, {'value': '25.37', 'spread': '17.010', 'groupId': 'OG001'}, {'value': '15.93', 'spread': '15.116', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '126', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.70', 'spread': '12.957', 'groupId': 'OG000'}, {'value': '0.37', 'spread': '12.041', 'groupId': 'OG001'}, {'value': '-1.24', 'spread': '7.975', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'COMPASS 31 questionnaire measures autonomic symptoms in participants with neuropathy. The questionnaire consists of 31 clinically selected questions evaluating 6 autonomic domains (orthostatic intolerance, secretomotor, gastrointestinal, bladder, and pupillomotor). COMPASS 31 is measured on a scale from 0 to 100, with 100 representing maximum impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Modified Body Mass Index (mBMI) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '881.8', 'spread': '219.10', 'groupId': 'OG000'}, {'value': '970.7', 'spread': '218.40', 'groupId': 'OG001'}, {'value': '1002.3', 'spread': '173.80', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '74.0', 'spread': '146.85', 'groupId': 'OG000'}, {'value': '31.6', 'spread': '119.28', 'groupId': 'OG001'}, {'value': '77.8', 'spread': '91.36', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'Nutritional status of participants was evaluated using the mBMI, calculated as BMI (kilograms per square meter \\[kg/m\\^2\\]) multiplied by the concentration of serum albumin (grams per liter \\[g/L\\]). A positive change from baseline indicates improvement in nutritional status.', 'unitOfMeasure': 'kg.g/m^2.L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Rasch-built Overall Disability Scale (R-ODS) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '12.74', 'groupId': 'OG000'}, {'value': '29.7', 'spread': '12.56', 'groupId': 'OG001'}, {'value': '36.7', 'spread': '10.29', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '5.25', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '6.78', 'groupId': 'OG001'}, {'value': '-2.7', 'spread': '3.60', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The R-ODS is a 24-item patient-reported questionnaire that specifically captures activity and social participation limitations. It measures the level of disability on a scale of 0 (worst) to 48 (best, no limitations), higher score indicates a better outcome. A negative change from baseline indicates worsening of disability.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the NIS+7 Component: NIS-Weakness (NIS-W) Score at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '47.01', 'spread': '31.323', 'groupId': 'OG000'}, {'value': '33.26', 'spread': '27.434', 'groupId': 'OG001'}, {'value': '15.02', 'spread': '17.988', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '9.10', 'spread': '13.297', 'groupId': 'OG000'}, {'value': '7.37', 'spread': '11.707', 'groupId': 'OG001'}, {'value': '6.97', 'spread': '13.235', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The NIS+7 provides additional, objective measures of nerve fiber function and autonomic nerve function in participants with diabetic neuropathy. The NIS+7 includes the full NIS (NIS-W, NIS-R, NIS-S), sum of 5 nerve conduction studies (NCS) (Sural SNAP, tibial motor nerve distal latency, peroneal CMAP, motor nerve conduction velocity, motor nerve distal latency), vibration detection threshold, and pulse rate response to deep breathing. NIS-W is a measure of motor strength, comprised of cranial nerve and both upper and lower limb motor assessments. The score ranges from 0 to 192. A higher score indicates greater severity of disease.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the 10-meter Walk Test (10-MWT) Speed at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.538', 'spread': '0.0553', 'groupId': 'OG000'}, {'value': '0.851', 'spread': '0.0422', 'groupId': 'OG001'}, {'value': '1.262', 'spread': '0.0826', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '92', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.011', 'spread': '0.0339', 'groupId': 'OG000'}, {'value': '-0.050', 'spread': '0.0542', 'groupId': 'OG001'}, {'value': '-0.121', 'spread': '0.0487', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': '10-MWT is a measure of ambulatory ability and walk speed. It measures the speed (in meters per second \\[m/s\\]) of a participant to walk 10 meters. A negative change from baseline represents decreased ambulatory ability.', 'unitOfMeasure': 'm/s', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Hand Grip Strength at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.23', 'spread': '1.293', 'groupId': 'OG000'}, {'value': '18.03', 'spread': '1.081', 'groupId': 'OG001'}, {'value': '27.86', 'spread': '2.626', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.14', 'spread': '0.461', 'groupId': 'OG000'}, {'value': '-0.34', 'spread': '0.615', 'groupId': 'OG001'}, {'value': '-0.28', 'spread': '0.807', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 52', 'description': 'Hand grip strength was measured by dynamometer. Grip strength in the dominant arm is a measure of motor function, with a higher grip strength indicating better motor function. The mean change from baseline in the hand grip strength was reported.', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in the Polyneuropathy Disability (PND) Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Year 5', 'description': 'PND measures changes in the ambulatory ability including the need of walking aids on the following stages: 0 (no symptoms), I (sensory disturbances but preserved walking capability), II (impaired walking capability but ability to walk without a stick or crutches), IIIA (walking with help of 1 stick/crutch), IIIB (with help of 2 sticks/crutches), and IV (confined to wheelchair or bedridden). Lower scores indicate greater ambulatory function. The number of participants with change in the stage from baseline was reported as: Improved or worsened.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in the Familial Amyloidotic Polyneuropathy (FAP) Stage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '93', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Year 5', 'description': 'FAP measures changes in the ambulatory ability including the need of walking aids on the following stages: 0 (no symptoms), I (unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs), II (assistance with ambulation required; moderate impairment of the lower limbs, upper limbs, and trunk), and III (wheelchair-bound or bedridden; severe sensory, motor, and autonomic involvement of all limbs). Lower scores indicate greater ambulatory function. The number of participants with change in the stage from baseline was reported as: Improved or worsened.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Change From Baseline in the New York Heart Association (NYHA) Classification', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Improved', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Worsened', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline, Year 5', 'description': 'NYHA classification grades the severity of heart failure symptoms into the following stages: I (no symptoms; ordinary physical activity such as walking and climbing stairs does not cause fatigue or dyspnea), II (symptoms with ordinary physical activity; walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold weather, in wind or when under emotional stress causes undue fatigue or dyspnea), III (symptoms with less than ordinary physical activity; walking 1 to 2 blocks on the level and climbing more than 1 flight of stairs in normal conditions causes undue fatigue or dyspnea), IV (symptoms at rest; inability to carry on any physical activity without fatigue or dyspnea). The number of participants with change in the stage from baseline was reported as: Improved or worsened.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Intraepidermal Nerve Fiber Density (IENFD) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Epidermal Nerve Fibers, Thigh: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.71', 'spread': '5.249', 'groupId': 'OG000'}, {'value': '5.41', 'spread': '5.291', 'groupId': 'OG001'}, {'value': '8.99', 'spread': '10.027', 'groupId': 'OG002'}]}]}, {'title': 'Epidermal Nerve, Fibers, Thigh: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.28', 'spread': '2.298', 'groupId': 'OG000'}, {'value': '-2.75', 'spread': '3.126', 'groupId': 'OG001'}, {'value': '-5.53', 'spread': '7.998', 'groupId': 'OG002'}]}]}, {'title': 'Epidermal Nerve Fibers, Leg: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.47', 'spread': '0.843', 'groupId': 'OG000'}, {'value': '1.70', 'spread': '3.183', 'groupId': 'OG001'}, {'value': '3.66', 'spread': '8.286', 'groupId': 'OG002'}]}]}, {'title': 'Epidermal Nerve Fibers, Leg: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.25', 'spread': '0.495', 'groupId': 'OG000'}, {'value': '-1.31', 'spread': '1.879', 'groupId': 'OG001'}, {'value': '-3.50', 'spread': '8.428', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'IENFD (fibers/millimeter \\[mm\\]) is a measure for the pathologic evaluation of sensory and autonomic innervation. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg. An increase in nerve fiber density suggests improvement, while a decrease in nerve fiber density suggests worsening.', 'unitOfMeasure': 'fibers/mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Sweat Gland Nerve Fiber Density (SGNFD) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Sweat Gland Nerve Fibers, Thigh: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '19', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.82', 'spread': '6.638', 'groupId': 'OG000'}, {'value': '9.67', 'spread': '4.942', 'groupId': 'OG001'}, {'value': '9.14', 'spread': '4.802', 'groupId': 'OG002'}]}]}, {'title': 'Sweat Gland Nerve Fibers, Thigh: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.56', 'spread': '2.648', 'groupId': 'OG000'}, {'value': '-2.49', 'spread': '5.636', 'groupId': 'OG001'}, {'value': '-3.29', 'spread': '4.323', 'groupId': 'OG002'}]}]}, {'title': 'Sweat Gland Nerve Fibers, Leg: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '59', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.82', 'spread': '3.363', 'groupId': 'OG000'}, {'value': '4.99', 'spread': '4.274', 'groupId': 'OG001'}, {'value': '5.93', 'spread': '4.355', 'groupId': 'OG002'}]}]}, {'title': 'Sweat Gland Nerve Fibers, Leg: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '9', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.43', 'spread': '2.351', 'groupId': 'OG000'}, {'value': '-2.47', 'spread': '3.605', 'groupId': 'OG001'}, {'value': '-1.31', 'spread': '2.867', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'SGNFD (meter/cubic millimeter \\[m/mm\\^3\\]) is a measure for the pathologic evaluation of sensory and autonomic innervation. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg. An increase in nerve fiber density suggests improvement, while a decrease in nerve fiber density suggests worsening.', 'unitOfMeasure': 'm/mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number of participants analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Dermal Amyloid Burden at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Amyloid Stain, Thigh: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.163', 'spread': '10.6544', 'groupId': 'OG000'}, {'value': '8.205', 'spread': '10.8725', 'groupId': 'OG001'}, {'value': '5.908', 'spread': '7.6646', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid Stain, Thigh: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-3.775', 'spread': '5.3387', 'groupId': 'OG000'}, {'value': '-1.103', 'spread': '7.5569', 'groupId': 'OG001'}, {'value': '-3.100', 'spread': '5.7269', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid Stain, Leg: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '60', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '11.062', 'spread': '10.4857', 'groupId': 'OG000'}, {'value': '10.386', 'spread': '12.3967', 'groupId': 'OG001'}, {'value': '7.441', 'spread': '8.5566', 'groupId': 'OG002'}]}]}, {'title': 'Amyloid Stain, Leg: Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.475', 'spread': '5.6922', 'groupId': 'OG000'}, {'value': '-2.793', 'spread': '6.2309', 'groupId': 'OG001'}, {'value': '-3.935', 'spread': '6.6372', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'Dermal Amyloid Burden is a measure for the pathologic evaluation of sensory and autonomic innervation and reported as % congo red stain. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg.', 'unitOfMeasure': 'percent congo red stain', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis of the specified parameter at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cardiac Biomarker: Serum Troponin I at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.109', 'spread': '0.0360', 'groupId': 'OG000'}, {'value': '0.112', 'spread': '0.0963', 'groupId': 'OG001'}, {'value': '0.088', 'spread': '0.0263', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.546', 'spread': '2.3345', 'groupId': 'OG000'}, {'value': '-0.005', 'spread': '0.0244', 'groupId': 'OG001'}, {'value': '0.014', 'spread': '0.0277', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'Manifestations of cardiac amyloid involvement were assessed through measurement of serum levels of the cardiac biomarker: troponin (micrograms per liter \\[µg/L\\]). The troponin I values \\<0.1 μg/L were imputed to 0.1 thus the actual changes cannot be calculated for values \\<0.1 μg/L.', 'unitOfMeasure': 'µg/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Cardiac Biomarker: N-terminal Prohormone of B-type Natriuretic Peptide (NT-proBNP) at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1957.649', 'spread': '2731.3296', 'groupId': 'OG000'}, {'value': '1017.217', 'spread': '1558.7632', 'groupId': 'OG001'}, {'value': '281.899', 'spread': '421.9627', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-18.490', 'spread': '910.2156', 'groupId': 'OG000'}, {'value': '209.126', 'spread': '487.2140', 'groupId': 'OG001'}, {'value': '78.146', 'spread': '266.1912', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'Manifestations of cardiac amyloid involvement were assessed through measurement of serum levels of the cardiac biomarker: NT-proBNP (nanograms per liter \\[ng/L\\]).', 'unitOfMeasure': 'ng/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: Average Peak Longitudinal Strain at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-15.63', 'spread': '3.348', 'groupId': 'OG000'}, {'value': '-15.96', 'spread': '3.283', 'groupId': 'OG001'}, {'value': '-17.72', 'spread': '4.079', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.43', 'spread': '3.634', 'groupId': 'OG000'}, {'value': '2.30', 'spread': '3.300', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '3.082', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of systolic function: Average peak longitudinal strain (percentage \\[%\\]).', 'unitOfMeasure': 'percentage', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: Left Ventricular (LV) Mass at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '238.166', 'spread': '74.0536', 'groupId': 'OG000'}, {'value': '236.604', 'spread': '85.8152', 'groupId': 'OG001'}, {'value': '198.570', 'spread': '89.1780', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.723', 'spread': '52.1737', 'groupId': 'OG000'}, {'value': '-4.222', 'spread': '48.2397', 'groupId': 'OG001'}, {'value': '-17.152', 'spread': '50.9296', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: LV mass (grams \\[g\\]).', 'unitOfMeasure': 'grams', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: LV End-diastolic Volume at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '80.591', 'spread': '26.5862', 'groupId': 'OG000'}, {'value': '83.616', 'spread': '25.6990', 'groupId': 'OG001'}, {'value': '107.818', 'spread': '34.8418', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.173', 'spread': '15.9316', 'groupId': 'OG000'}, {'value': '-1.279', 'spread': '20.0305', 'groupId': 'OG001'}, {'value': '-11.710', 'spread': '32.1329', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of diastolic function: LV end-diastolic volume (milliliters \\[mL\\]).', 'unitOfMeasure': 'mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: LV Relative Wall Thickness at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.780', 'spread': '0.1616', 'groupId': 'OG000'}, {'value': '0.717', 'spread': '0.1840', 'groupId': 'OG001'}, {'value': '0.593', 'spread': '0.1802', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.066', 'spread': '0.1344', 'groupId': 'OG000'}, {'value': '-0.061', 'spread': '0.1320', 'groupId': 'OG001'}, {'value': '-0.037', 'spread': '0.0887', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: LV relative wall thickness (ratio).', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: Mean LV Wall Thickness at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IVQ3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1.538', 'spread': '0.2776', 'groupId': 'OG000'}, {'value': '1.463', 'spread': '0.3210', 'groupId': 'OG001'}, {'value': '1.249', 'spread': '0.3321', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '89', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.035', 'spread': '0.1782', 'groupId': 'OG000'}, {'value': '-0.041', 'spread': '0.1874', 'groupId': 'OG001'}, {'value': '-0.042', 'spread': '0.1794', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: Mean LV wall thickness (centimeters \\[cm\\]).', 'unitOfMeasure': 'cm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Echocardiogram Parameter: Cardiac Output at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '136', 'groupId': 'OG001'}, {'value': '25', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.547', 'spread': '1.0373', 'groupId': 'OG000'}, {'value': '3.840', 'spread': '1.1748', 'groupId': 'OG001'}, {'value': '4.873', 'spread': '1.6902', 'groupId': 'OG002'}]}]}, {'title': 'Change From Baseline at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '83', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.010', 'spread': '1.1551', 'groupId': 'OG000'}, {'value': '-0.283', 'spread': '1.1012', 'groupId': 'OG001'}, {'value': '-0.594', 'spread': '1.5476', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of systolic function: Cardiac output (liters per minute \\[L/min\\]).', 'unitOfMeasure': 'L/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Full analysis set included all participants who were enrolled in this study. 'Overall number of participants analyzed' indicates the number of participants with data available for outcome measure analysis. 'Number analyzed' indicates the number of participants with data available for analysis at specified timepoint."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline in Serum TTR Levels at Year 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 65.5 months.'}, {'id': 'OG001', 'title': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.'}, {'id': 'OG002', 'title': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.'}], 'classes': [{'categories': [{'measurements': [{'value': '-90.010', 'spread': '7.4802', 'groupId': 'OG000'}, {'value': '-37.660', 'spread': '35.2948', 'groupId': 'OG001'}, {'value': '-39.965', 'spread': '56.5274', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Year 5', 'description': 'Serum TTR was assessed using enzyme linked immunosorbent assay (ELISA).', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "PD analysis set included all participants who received at least 1 dose of patisiran in this study and have had both baseline and at least 1 post-baseline PD assessment (either TTR or vitamin A). 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'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '10'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants took part in the study at investigational sites in Asia, Europe, Canada, the United Kingdom, and the United States from 16 July 2015 to 23 November 2022.', 'preAssignmentDetails': 'A total of 211 participants who completed either ALN-TTR02-003 (NCT01961921) or ALN-TTR02-004 (NCT01960348) studies were enrolled into the study to receive at least 1 dose of patisiran.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Prior Placebo Group of Study 004', 'description': 'Participants who received 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[{'value': '63.5', 'spread': '11.02', 'groupId': 'BG000'}, {'value': '61.0', 'spread': '12.10', 'groupId': 'BG001'}, {'value': '58.5', 'spread': '15.09', 'groupId': 'BG002'}, {'value': '61.3', 'spread': '12.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '37', 'groupId': 'BG000'}, {'value': '102', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '156', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'BG000'}, {'value': '137', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '211', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '121', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}, {'value': '183', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, 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{'value': '2', 'groupId': 'BG003'}]}, {'title': 'More than One Race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Missing', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Serum Transthyretin (TTR) Level', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '40', 'groupId': 'BG000'}, {'value': '128', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '192', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '185.689', 'spread': '56.2895', 'groupId': 'BG000'}, {'value': '53.010', 'spread': '43.1782', 'groupId': 'BG001'}, {'value': '76.905', 'spread': '47.9088', 'groupId': 'BG002'}, {'value': '83.639', 'spread': '70.5576', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': "'Number analyzed' indicates the number of participants with data available for analysis of the specified measure."}], 'populationDescription': 'Full analysis set included all participants who were enrolled in this study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-02', 'size': 11490659, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-11-16T08:35', 'hasProtocol': True}, {'date': '2017-07-12', 'size': 5128850, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-16T08:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'All the participants received only patisiran but divided into 3 arm groups based on administration in the parent study (placebo or patisiran in 003 \\[NCT01961921\\] or 004 \\[NCT01960348\\] studies).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2015-07-16', 'resultsFirstSubmitDate': '2023-11-16', 'studyFirstSubmitQcDate': '2015-07-27', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-05', 'studyFirstPostDateStruct': {'date': '2015-07-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Adverse Events (AEs) Leading to Study Discontinuation', 'timeFrame': 'First dose up to 28 days after last dose of study drug (approximately 5.6 years)', 'description': 'AE is any untoward medical occurrence in a participant or clinical investigational subject administered a medicinal product and which does not necessarily have a causal relationship with this treatment.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in the Total Neuropathy Impairment Score (NIS) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The NIS assessment is a 244-point composite measure of neurologic impairment which includes a physical exam of lower limbs, upper limbs, and cranial nerves to assess the components: motor strength/weakness (NIS-W), reflexes (NIS-R), and sensation (NIS-S). NIS total score is obtained by combining all the component scores, ranging from 0 to 244. Higher scores represent a greater severity of disease. A positive change from baseline indicates the worsening of neuropathy.'}, {'measure': 'Change From Baseline in the Total Modified NIS (mNIS +7) Composite Score At Year 3', 'timeFrame': 'Baseline, Year 3', 'description': 'The mNIS+7 is a composite measure of neurologic impairment which includes the following components: physical exam of lower limbs, upper limbs, and cranial nerves to assess motor strength/weakness (192 points), reflexes (20 points), electrophysiologic measurement of small and large nerve fiber function (10 points), sensory testing (80 points), and postural blood pressure (2 points). The total mNIS+7 composite score is obtained by combining all the component scores, ranging from 0 (no impairment) to 304 (maximum impairment). A negative change from baseline indicates an improvement in neuropathy.'}, {'measure': 'Change From Baseline in the NIS+7 Total Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'The NIS+7 provides additional, objective measures of nerve fibre function and autonomic nerve function in participants with diabetic neuropathy. The NIS+7 includes the full NIS, sum of 5 nerve conduction studies (NCS) (Sural sensory nerve action potential \\[SNAP\\], tibial motor nerve distal latency, peroneal compound motor action potential \\[CMAP\\], motor nerve conduction velocity, motor nerve distal latency), vibration detection threshold, and pulse rate response to deep breathing. The total NIS+7 score is obtained by combining all the component scores, ranging from 0 (no impairment) to 270 points (maximum impairment). A positive change from baseline indicates worsening.'}, {'measure': 'Change From Baseline in the Norfolk Quality of Life-Diabetic Neuropathy (QoL-DN) Questionnaire Total Score at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The Norfolk QoL-DN questionnaire is a standardized 47-item patient-reported outcomes measure, sensitive to the perception of the effects of diabetic neuropathy by the participant. The scores range from -4 (best possible QOL) to 136 (worst possible QOL). A negative change from baseline represents improved QOL.'}, {'measure': 'Change From Baseline in the EuroQOL-5 Dimensions-5 Levels (EQ-5D-5L) Index Score at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The EQ-5D-5L is a patient-reported measure of QoL based on 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. The overall score is rated on a scale from 0 (worst) to 1 (no impairment). Higher scores indicate a higher QoL. A negative change from baseline indicates worsening of QoL.'}, {'measure': 'Change From Baseline in the EuroQoL Visual Analogue Scale (EQ-VAS) Score at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'EQ-VAS measures the participant\'s self-rated health on a vertical scale evaluated on a scale of 0 ("worst health you can imagine") to 100 ("best health you can imagine"). Higher scores indicate a higher QOL. A negative change from baseline indicates worsening of QoL.'}, {'measure': 'Change From Baseline in the Composite Autonomic Symptom Score (COMPASS 31) Total Score at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'COMPASS 31 questionnaire measures autonomic symptoms in participants with neuropathy. The questionnaire consists of 31 clinically selected questions evaluating 6 autonomic domains (orthostatic intolerance, secretomotor, gastrointestinal, bladder, and pupillomotor). COMPASS 31 is measured on a scale from 0 to 100, with 100 representing maximum impairment.'}, {'measure': 'Change From Baseline in the Modified Body Mass Index (mBMI) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'Nutritional status of participants was evaluated using the mBMI, calculated as BMI (kilograms per square meter \\[kg/m\\^2\\]) multiplied by the concentration of serum albumin (grams per liter \\[g/L\\]). A positive change from baseline indicates improvement in nutritional status.'}, {'measure': 'Change From Baseline in the Rasch-built Overall Disability Scale (R-ODS) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The R-ODS is a 24-item patient-reported questionnaire that specifically captures activity and social participation limitations. It measures the level of disability on a scale of 0 (worst) to 48 (best, no limitations), higher score indicates a better outcome. A negative change from baseline indicates worsening of disability.'}, {'measure': 'Change From Baseline in the NIS+7 Component: NIS-Weakness (NIS-W) Score at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The NIS+7 provides additional, objective measures of nerve fiber function and autonomic nerve function in participants with diabetic neuropathy. The NIS+7 includes the full NIS (NIS-W, NIS-R, NIS-S), sum of 5 nerve conduction studies (NCS) (Sural SNAP, tibial motor nerve distal latency, peroneal CMAP, motor nerve conduction velocity, motor nerve distal latency), vibration detection threshold, and pulse rate response to deep breathing. NIS-W is a measure of motor strength, comprised of cranial nerve and both upper and lower limb motor assessments. The score ranges from 0 to 192. A higher score indicates greater severity of disease.'}, {'measure': 'Change From Baseline in the 10-meter Walk Test (10-MWT) Speed at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': '10-MWT is a measure of ambulatory ability and walk speed. It measures the speed (in meters per second \\[m/s\\]) of a participant to walk 10 meters. A negative change from baseline represents decreased ambulatory ability.'}, {'measure': 'Change From Baseline in the Hand Grip Strength at Week 52', 'timeFrame': 'Baseline, Week 52', 'description': 'Hand grip strength was measured by dynamometer. Grip strength in the dominant arm is a measure of motor function, with a higher grip strength indicating better motor function. The mean change from baseline in the hand grip strength was reported.'}, {'measure': 'Number of Participants With Change From Baseline in the Polyneuropathy Disability (PND) Stage', 'timeFrame': 'Baseline, Year 5', 'description': 'PND measures changes in the ambulatory ability including the need of walking aids on the following stages: 0 (no symptoms), I (sensory disturbances but preserved walking capability), II (impaired walking capability but ability to walk without a stick or crutches), IIIA (walking with help of 1 stick/crutch), IIIB (with help of 2 sticks/crutches), and IV (confined to wheelchair or bedridden). Lower scores indicate greater ambulatory function. The number of participants with change in the stage from baseline was reported as: Improved or worsened.'}, {'measure': 'Number of Participants With Change From Baseline in the Familial Amyloidotic Polyneuropathy (FAP) Stage', 'timeFrame': 'Baseline, Year 5', 'description': 'FAP measures changes in the ambulatory ability including the need of walking aids on the following stages: 0 (no symptoms), I (unimpaired ambulation; mostly mild sensory, motor, and autonomic neuropathy in the lower limbs), II (assistance with ambulation required; moderate impairment of the lower limbs, upper limbs, and trunk), and III (wheelchair-bound or bedridden; severe sensory, motor, and autonomic involvement of all limbs). Lower scores indicate greater ambulatory function. The number of participants with change in the stage from baseline was reported as: Improved or worsened.'}, {'measure': 'Number of Participants With Change From Baseline in the New York Heart Association (NYHA) Classification', 'timeFrame': 'Baseline, Year 5', 'description': 'NYHA classification grades the severity of heart failure symptoms into the following stages: I (no symptoms; ordinary physical activity such as walking and climbing stairs does not cause fatigue or dyspnea), II (symptoms with ordinary physical activity; walking or climbing stairs rapidly, walking uphill, walking or stair climbing after meals, in cold weather, in wind or when under emotional stress causes undue fatigue or dyspnea), III (symptoms with less than ordinary physical activity; walking 1 to 2 blocks on the level and climbing more than 1 flight of stairs in normal conditions causes undue fatigue or dyspnea), IV (symptoms at rest; inability to carry on any physical activity without fatigue or dyspnea). The number of participants with change in the stage from baseline was reported as: Improved or worsened.'}, {'measure': 'Change From Baseline in the Intraepidermal Nerve Fiber Density (IENFD) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'IENFD (fibers/millimeter \\[mm\\]) is a measure for the pathologic evaluation of sensory and autonomic innervation. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg. An increase in nerve fiber density suggests improvement, while a decrease in nerve fiber density suggests worsening.'}, {'measure': 'Change From Baseline in the Sweat Gland Nerve Fiber Density (SGNFD) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'SGNFD (meter/cubic millimeter \\[m/mm\\^3\\]) is a measure for the pathologic evaluation of sensory and autonomic innervation. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg. An increase in nerve fiber density suggests improvement, while a decrease in nerve fiber density suggests worsening.'}, {'measure': 'Change From Baseline in the Dermal Amyloid Burden at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'Dermal Amyloid Burden is a measure for the pathologic evaluation of sensory and autonomic innervation and reported as % congo red stain. It is obtained by tandem 3 mm skin punch biopsies: one set of biopsies taken from the distal thigh and one set from the distal lower leg.'}, {'measure': 'Change From Baseline in the Cardiac Biomarker: Serum Troponin I at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'Manifestations of cardiac amyloid involvement were assessed through measurement of serum levels of the cardiac biomarker: troponin (micrograms per liter \\[µg/L\\]). The troponin I values \\<0.1 μg/L were imputed to 0.1 thus the actual changes cannot be calculated for values \\<0.1 μg/L.'}, {'measure': 'Change From Baseline in the Cardiac Biomarker: N-terminal Prohormone of B-type Natriuretic Peptide (NT-proBNP) at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'Manifestations of cardiac amyloid involvement were assessed through measurement of serum levels of the cardiac biomarker: NT-proBNP (nanograms per liter \\[ng/L\\]).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: Average Peak Longitudinal Strain at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of systolic function: Average peak longitudinal strain (percentage \\[%\\]).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: Left Ventricular (LV) Mass at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: LV mass (grams \\[g\\]).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: LV End-diastolic Volume at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of diastolic function: LV end-diastolic volume (milliliters \\[mL\\]).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: LV Relative Wall Thickness at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: LV relative wall thickness (ratio).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: Mean LV Wall Thickness at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of cardiac structure: Mean LV wall thickness (centimeters \\[cm\\]).'}, {'measure': 'Change From Baseline in the Echocardiogram Parameter: Cardiac Output at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'The echocardiogram parameters analyzed included measures of systolic function: Cardiac output (liters per minute \\[L/min\\]).'}, {'measure': 'Percent Change From Baseline in Serum TTR Levels at Year 5', 'timeFrame': 'Baseline, Year 5', 'description': 'Serum TTR was assessed using enzyme linked immunosorbent assay (ELISA).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['RNAi therapeutic', 'FAP', 'Familial Amyloid Polyneuropathy', 'TTR', 'Transthyretin', 'Amyloidosis'], 'conditions': ['Amyloidosis']}, 'referencesModule': {'references': [{'pmid': '39804640', 'type': 'DERIVED', 'citation': 'Adams D, Wixner J, Polydefkis M, Berk JL, Conceicao IM, Dispenzieri A, Peltier A, Ueda M, Bender S, Capocelli K, Jay PY, Yureneva E, Obici L; patisiran Global OLE study group. Five-Year Results With Patisiran for Hereditary Transthyretin Amyloidosis With Polyneuropathy: A Randomized Clinical Trial With Open-Label Extension. JAMA Neurol. 2025 Mar 1;82(3):228-236. doi: 10.1001/jamaneurol.2024.4631.'}, {'pmid': '38548524', 'type': 'DERIVED', 'citation': 'Lin KP, Yang CC, Lee YC, Lee MJ, Vest J, Sweetser MT, White MT, Badri P, Hsieh ST, Chao CC. Patisiran, an RNAi therapeutic for hereditary transthyretin-mediated amyloidosis: Sub-analysis in Taiwanese patients from the APOLLO study. J Formos Med Assoc. 2024 Sep;123(9):975-984. doi: 10.1016/j.jfma.2024.03.008. Epub 2024 Mar 27.'}, {'pmid': '33212063', 'type': 'DERIVED', 'citation': 'Adams D, Polydefkis M, Gonzalez-Duarte A, Wixner J, Kristen AV, Schmidt HH, Berk JL, Losada Lopez IA, Dispenzieri A, Quan D, Conceicao IM, Slama MS, Gillmore JD, Kyriakides T, Ajroud-Driss S, Waddington-Cruz M, Mezei MM, Plante-Bordeneuve V, Attarian S, Mauricio E, Brannagan TH 3rd, Ueda M, Aldinc E, Wang JJ, White MT, Vest J, Berber E, Sweetser MT, Coelho T; patisiran Global OLE study group. Long-term safety and efficacy of patisiran for hereditary transthyretin-mediated amyloidosis with polyneuropathy: 12-month results of an open-label extension study. Lancet Neurol. 2021 Jan;20(1):49-59. doi: 10.1016/S1474-4422(20)30368-9. Epub 2020 Nov 16.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of long-term dosing with ALN-TTR02 (patisiran) in participants with transthyretin (TTR) mediated amyloidosis (ATTR).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have completed a patisiran study (i.e., completed the last efficacy visit in the parent study) and, in the opinion of the investigator, tolerated study drug\n* Be willing and able to comply with the protocol-required visit schedule and visit requirements and provide written informed consent\n\nExclusion Criteria:\n\n* Any new or uncontrolled condition that could make the participant unsuitable for participation'}, 'identificationModule': {'nctId': 'NCT02510261', 'briefTitle': 'The Study of an Investigational Drug, Patisiran (ALN-TTR02), for the Treatment of Transthyretin (TTR)-Mediated Amyloidosis in Participants Who Have Already Been Treated With ALN-TTR02 (Patisiran)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alnylam Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Open-Label, Extension Study to Evaluate the Long-term Safety and Efficacy of Patisiran in Patients With Familial Amyloidotic Polyneuropathy Who Have Completed a Prior Patisiran Clinical Study', 'orgStudyIdInfo': {'id': 'ALN-TTR02-006'}, 'secondaryIdInfos': [{'id': '2014-003877-40', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prior Placebo Group of Study 004', 'description': 'Participants who received placebo and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 milligrams per kilogram (mg/kg) patisiran intravenously (IV) once every 3 weeks (Q3W) up to 65.5 months.', 'interventionNames': ['Drug: Patisiran']}, {'type': 'EXPERIMENTAL', 'label': 'Prior Patisiran Group of Study 004', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-004 (NCT01960348) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 66.9 months.', 'interventionNames': ['Drug: Patisiran']}, {'type': 'EXPERIMENTAL', 'label': 'Prior Patisiran Group of Study 003', 'description': 'Participants who received patisiran and completed parent study ALN-TTR02-003 (NCT01961921) were enrolled to receive 0.3 mg/kg patisiran IV Q3W up to 61.4 months.', 'interventionNames': ['Drug: Patisiran']}], 'interventions': [{'name': 'Patisiran', 'type': 'DRUG', 'otherNames': ['ALN-TTR02'], 'description': 'Patisiran was administered IV.', 'armGroupLabels': ['Prior Patisiran Group of Study 003', 'Prior Patisiran Group of Study 004', 'Prior Placebo Group of Study 004']}]}, 'contactsLocationsModule': {'locations': [{'city': 'La Mesa', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Trial Site', 'geoPoint': {'lat': 32.76783, 'lon': 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