Viewing Study NCT00925002

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Ignite Creation Date: 2025-12-25 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
Study NCT ID: NCT00925002
Status: COMPLETED
Last Update Posted: 2021-07-29
First Post: 2009-06-17
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C547076', 'term': 'tafamidis'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer Inc.'}, 'certainAgreement': {'otherDetails': 'Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Same event may appear as both an AE and Serious Adverse Events (SAE). However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another, or a participant may have experienced both a serious and non-serious event. Analysis performed on safety set.', 'eventGroups': [{'id': 'EG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.', 'otherNumAtRisk': 38, 'deathsNumAtRisk': 38, 'otherNumAffected': 34, 'seriousNumAtRisk': 38, 'deathsNumAffected': 3, 'seriousNumAffected': 6}, {'id': 'EG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.', 'otherNumAtRisk': 37, 'deathsNumAtRisk': 37, 'otherNumAffected': 32, 'seriousNumAtRisk': 37, 'deathsNumAffected': 1, 'seriousNumAffected': 9}, {'id': 'EG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 18, 'seriousNumAtRisk': 18, 'deathsNumAffected': 7, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bundle Branch Block Bilateral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Mitral Valve Incompetence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Tachycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vertigo Positional', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vision Blurred', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain Lower', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Abdominal Pain Upper', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dental Caries', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastrointestinal Motility Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Haemorrhoids', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Odynophagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Vomitting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Early Satiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Exercise Tolerance Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gait Disturbance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Implant Site Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Oedema Peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Burn Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Conjunctivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Ear Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Gastroenteritis Viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and 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'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Confusional State', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Renal Impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Cervical Dysplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Pleural Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Heart Transplant', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Deep Vein Thrombosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Orthostatic Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 38, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 37, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 18, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.8', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '11.6', 'spread': '14.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.8', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed " signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.8', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '11.3', 'spread': '1.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '31.1', 'spread': '24.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.5', 'spread': '2.0', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.0', 'spread': '2.7', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.1', 'spread': '26.3', 'groupId': 'OG000'}, {'value': '29.9', 'spread': '30.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '4.5', 'spread': '3.4', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 30', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '5.2', 'spread': '3.4', 'groupId': 'OG000'}, {'value': '5.3', 'spread': '3.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 66', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '53.9', 'spread': '34.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.9', 'spread': '5.7', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 12', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.9', 'spread': '7.4', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 60', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.8', 'spread': '12.99', 'groupId': 'OG000'}, {'value': '80.3', 'spread': '11.83', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 30 (Baseline of B3461023)', 'description': 'KPS: used for rating participant activities of daily living on 11-step scale from 0-100, higher score=participant is better able to carry out daily activities. Score range: 100=normal no complaints; no disease evidence, 90=able to carry normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry on normal activity, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care, assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead. The lower the score the worse is survival for most serious illnesses. Data for KPS score was not collected in parent studies Fx-005 and Fx-006, therefore not reported for any time points from parent studies.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '85.9', 'spread': '10.76', 'groupId': 'OG000'}, {'value': '78.7', 'spread': '17.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 66 (Month 36 of B3461023)', 'description': 'KPS: used for rating participant activities of daily living on 11-step scale from 0-100, higher score=participant is better able to carry out daily activities. Score range: 100=normal no complaints; no disease evidence, 90=able to carry normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry on normal activity, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care, assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead. The lower the score the worse is survival for most serious illnesses. Data for KPS score was not collected in parent studies Fx-005 and Fx-006, therefore not reported for any time points from parent studies.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Karnofsky Performance Scale (KPS) Score at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.2', 'spread': '13.53', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.1', 'spread': '2.57', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 12', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '-12.4', 'spread': '3.73', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 60', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Number of Participants by Ambulation Stage at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on modified polyneuropathy disability (mPND) score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Number of Participants by Ambulation Stage at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 30', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'Val30Met Group: Number of Participants by Ambulation Stage at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 66', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 12', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'PRIMARY', 'title': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 60', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, "Overall number of participants analyzed" signifies participants who were evaluable for this outcome measure.'}, {'type': 'SECONDARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in NIS-LL Score at Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114 and 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '6.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.3', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.8', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '9.8', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '17.1', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '8.6', 'spread': '2.8', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '26.0', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '12.5', 'spread': '3.0', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '14.2', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.4', 'spread': '4.6', 'groupId': 'OG000'}, {'value': '12.6', 'spread': '4.6', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114 and 126', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met Group: NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL MW: Baseline', 'categories': [{'measurements': [{'value': '2.1', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '4.2', 'spread': '9.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Baseline', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Baseline', 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Baseline', 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '3.7', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Baseline', 'categories': [{'measurements': [{'value': '1.3', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Baseline', 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Baseline', 'categories': [{'measurements': [{'value': '3.9', 'spread': '3.7', 'groupId': 'OG000'}, {'value': '5.6', 'spread': '3.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'SECONDARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114 and 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL MW: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '4.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '6.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '5.7', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '7.4', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.7', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '6.9', 'spread': '2.1', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.0', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.2', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.5', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '9.1', 'spread': '2.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '27.9', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '10.0', 'spread': '3.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.3', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.7', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.8', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.4', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '3.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.5', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '2.4', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.2', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.8', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '2.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114 and 126', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in NIS-LL Score at Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.6', 'spread': '2.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.3', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.4', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '12.9', 'spread': '4.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '13.9', 'spread': '4.4', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL MW: Baseline', 'categories': [{'measurements': [{'value': '16.6', 'spread': '16.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Baseline', 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Baseline', 'categories': [{'measurements': [{'value': '2.5', 'spread': '3.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Baseline', 'categories': [{'measurements': [{'value': '5.5', 'spread': '6.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Baseline', 'categories': [{'measurements': [{'value': '6.9', 'spread': '6.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Baseline', 'categories': [{'measurements': [{'value': '5.6', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Baseline', 'categories': [{'measurements': [{'value': '8.9', 'spread': '5.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'NIS-LL MW: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.5', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.3', 'spread': '1.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.7', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.1', 'spread': '3.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '3.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Hip: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Knee: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.7', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.3', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Ankle: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.0', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.8', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL MW-Toe: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '1.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Reflexes: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.7', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.4', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'NIS-LL Sensory: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.9', 'spread': '1.4', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114, 126, 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'TQOL: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.8', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '5.4', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '6.4', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '3.4', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '4.8', 'groupId': 'OG000'}, {'value': '-3.9', 'spread': '5.6', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '5.2', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '6.0', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '5.9', 'groupId': 'OG000'}, {'value': '-7.3', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '18.9', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '-9.0', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '48.1', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '8.7', 'groupId': 'OG001'}]}]}, {'title': 'TQOL: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '26.0', 'spread': '12.0', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114, 126, 138', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met Group: TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Symptom: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.4', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.4', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '4.6', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.4', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '15.9', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '3.2', 'groupId': 'OG000'}, {'value': '3.1', 'spread': '4.2', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '2.8', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met:Change From Baseline in TQOL Subscale Scores:Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Symptom: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '-2.8', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-3.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.4', 'groupId': 'OG000'}, {'value': '-1.3', 'spread': '2.4', 'groupId': 'OG001'}]}]}, {'title': 'Symptom: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '3.9', 'spread': '3.3', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.7', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.3', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '5.6', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '1.2', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.5', 'spread': '1.6', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '1.6', 'groupId': 'OG001'}]}]}, {'title': 'ADLs: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '2.2', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-1.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.9', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.7', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.7', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-3.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.0', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '1.9', 'spread': '1.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.3', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '1.8', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '-2.6', 'spread': '2.9', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.7', 'spread': '2.8', 'groupId': 'OG000'}, {'value': '0.1', 'spread': '3.2', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.0', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '-3.6', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '3.5', 'groupId': 'OG000'}, {'value': '-4.1', 'spread': '3.5', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.8', 'spread': '4.7', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '4.7', 'groupId': 'OG001'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '24.7', 'spread': '6.5', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '6.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.5', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '2.2', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.6', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '1.3', 'spread': '0.9', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.0', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '1.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.3', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '1.1', 'spread': '1.5', 'groupId': 'OG001'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '11.8', 'spread': '2.0', 'groupId': 'OG000'}, {'value': '6.8', 'spread': '2.0', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '-0.4', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.3', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '0.4', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.1', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '-1.9', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.8', 'spread': '0.7', 'groupId': 'OG000'}, {'value': '-1.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '-2.4', 'spread': '0.8', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.1', 'groupId': 'OG000'}, {'value': '-1.2', 'spread': '1.1', 'groupId': 'OG001'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.9', 'spread': '1.5', 'groupId': 'OG000'}, {'value': '-0.7', 'spread': '1.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114, 126 and 138', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 6, 24, 36, 48, 72, 84, 96, 108, 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'TQOL: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.0', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.0', 'spread': '5.7', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.8', 'spread': '6.3', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.5', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.2', 'spread': '10.1', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '9.5', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.5', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.0', 'spread': '11.9', 'groupId': 'OG000'}]}]}, {'title': 'TQOL: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '28.5', 'spread': '11.9', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 6, 24, 36, 48, 72, 84, 96, 108, 120', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Symptom: Baseline', 'categories': [{'measurements': [{'value': '10.3', 'spread': '7.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Baseline', 'categories': [{'measurements': [{'value': '8.4', 'spread': '6.9', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Baseline', 'categories': [{'measurements': [{'value': '28.7', 'spread': '18.1', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Baseline', 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.0', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Baseline', 'categories': [{'measurements': [{'value': '2.0', 'spread': '2.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure.'}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Change From Baseline in TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Symptom: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.5', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.0', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.5', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Symptom: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.8', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.4', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.4', 'spread': '1.9', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'ADLs: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '8.2', 'spread': '2.3', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-2.1', 'spread': '3.4', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.1', 'spread': '3.7', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.8', 'spread': '4.0', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.5', 'spread': '4.3', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.5', 'spread': '5.8', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '5.4', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '11.4', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Physical Functioning/Large Fiber Neuropathy: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15.4', 'spread': '6.8', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.4', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '0.9', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '1.2', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.5', 'spread': '1.3', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '4.1', 'spread': '1.7', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Small Fiber Neuropathy: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.1', 'spread': '2.1', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.5', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.4', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.3', 'spread': '0.5', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.2', 'spread': '0.6', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.6', 'spread': '0.8', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.6', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'Autonomic Neuropathy: Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 42, 54, 78, 90, 102, 114, 126 and 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '83.8', 'spread': '11.63', 'groupId': 'OG000'}, {'value': '81.5', 'spread': '11.32', 'groupId': 'OG001'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '86.1', 'spread': '10.22', 'groupId': 'OG000'}, {'value': '82.1', 'spread': '11.49', 'groupId': 'OG001'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78.9', 'spread': '14.53', 'groupId': 'OG000'}, {'value': '81.4', 'spread': '16.76', 'groupId': 'OG001'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.6', 'spread': '15.09', 'groupId': 'OG000'}, {'value': '81.7', 'spread': '14.72', 'groupId': 'OG001'}]}]}, {'title': 'Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '68.6', 'spread': '16.76', 'groupId': 'OG000'}, {'value': '80.0', 'spread': '10.00', 'groupId': 'OG001'}]}]}, {'title': 'Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '12.91', 'groupId': 'OG000'}, {'value': '82.5', 'spread': '9.57', 'groupId': 'OG001'}]}]}, {'title': 'Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '75.0', 'spread': '7.07', 'groupId': 'OG000'}, {'value': '75.0', 'spread': '21.21', 'groupId': 'OG001'}]}]}, {'title': 'Month 138', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '70.0', 'spread': 'NA', 'comment': 'The upper limit of 95% CI could not be estimated due to less number of participants with event.', 'groupId': 'OG000'}, {'value': '60.0', 'spread': 'NA', 'comment': 'The upper limit of 95% CI could not be estimated due to less number of participants with event.', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline of B3461023, Month 42, 54, 78, 90, 102, 114, 126 and 138', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Change at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.9', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': '2.57', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-4.8', 'spread': '3.09', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.6', 'spread': '3.22', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'spread': '4.76', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '6.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '6.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-3.3', 'spread': '6.56', 'groupId': 'OG000'}]}]}, {'title': 'Change at Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-33.3', 'spread': '6.56', 'groupId': 'OG000'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline of B3461022, Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Val30Met Group: Number of Participants by Ambulation Stage at Week 12, Month 6, 9, 12, 18, 21, 24, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126, 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 9', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '34', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 123', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Month 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12, Month 6, 9, 12, 18, 21, 24, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126 and 129', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 3, 6, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126, 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 15', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 21', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 27', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '7', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 33', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 36', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '9', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 39', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '8', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 42', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Month 45', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Month 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 51', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 54', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 57', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '6', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 63', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 66', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 69', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 72', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 75', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 78', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 81', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 84', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 87', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 93', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 96', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 99', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 102', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 105', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 108', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 111', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 114', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 117', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 120', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 123', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 126', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Month 129', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Stage 1 (Normal)', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'Stage 2 (Some assistance required)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'Stage 3 (Not ambulatory)', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Month 3, 6, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126 and 129', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "ITT population included all enrolled participants who had taken at least one dose of study medication, and who had baseline and at least one post-baseline NIS-LL measure. Here, 'number analyzed'=participants with available data for each specified category."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'Treatment-Emergent AEs', 'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '33', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}, {'title': 'Treatment-emergent SAEs', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent AEs were events that emerged after enrollment in B3461023 (Fx1A-303) or which worsened during the course of B3461023 (Fx1A-303) relative to the pretreatment state. AEs included both SAEs and non-SAEs.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormality in Physical Examinations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '29', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': "Complete physical examination included examination of the general appearance, head and neck, ears, eyes, nose, throat, respiratory, genitourinary, endocrine, cardiovascular, abdomen, skin, musculoskeletal, neurological, immunologic/allergies, hematologic/lymphatic. Abnormality in physical findings were based on investigator's decision.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Laboratory Test Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}, {'value': '12', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Abnormalities criteria: Serum chemistry (bilirubin\\>1.5\\*upper limit normal \\[ULN\\]; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma glutamyl transferase \\>3.0\\*ULN; albumin\\<0.8\\*lower limit normal \\[LLN\\],\\>1.2\\*ULN; blood urea nitrogen, creatinine\\>1.3\\*ULN; free T4, thyrotropin, thyroxine \\<0.8\\*LLN,\\>1.2\\*ULN; glucose\\<0.6\\*LLN,\\>1.5\\*ULN); Coagulation (prothrombin time, prothrombin int. normalized ratio \\>1.1\\*ULN); Hematology(basophils; eosinophils, monocytes \\>1.2\\*ULN; leukocytes \\<0.6\\*LLN,\\>1.5\\*ULN; lymphocytes, neutrophils \\<0.8\\*LLN, \\>1.2\\*ULN).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'title': 'QT Interval (msec): >450-480', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval (msec): >480-500', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'QT Interval (msec): >500', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}]}, {'title': "Bazett's Correction Formula (QTcB) (msec): >450-480", 'categories': [{'measurements': [{'value': '14', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}]}, {'title': "Bazett's Correction Formula (QTcB) (msec): >480-500", 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': "Bazett's Correction Formula (QTcB) (msec): >500", 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}, {'title': "Fridericia's Correction Formula (QTcF) (msec): >450-480", 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': "Fridericia's Correction Formula (QTcF) (msec): >480-500", 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': "Fridericia's Correction Formula (QTcF) (msec): >500", 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': "Twelve-lead ECGs were obtained for all participants. Criteria for QT interval, Bazett's correction formula (QTcB) and Fridericia's correction formula (QTcF): greater than (\\>) 450-480 millisecond (msec), \\>480-500 msec and \\>500 msec. Findings were considered to be abnormal based on investigator's decision.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Clinically Significant Changes From Baseline in Vital Signs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Criteria for clinically significant changes: Supine and standing systolic blood pressure (BP): decrease from baseline of less than or equal to (\\<=) -20 millimeter of mercury (mmHg), increase from baseline of greater than or equal to (\\>=) 20 mmHg, systolic BP \\<90 mmHg or \\>180 mmHg; Supine and standing diastolic BP: decrease from baseline of \\<=-15 mmHg, increase from baseline of \\>= 15 mmHg, diastolic BP \\<50 mmHg or \\>105 mmHg; Supine and standing pulse rate: decrease from baseline of \\<=-15 beats per minute (bpm), increase from baseline of \\>=15 bpm, pulse rate \\<50 bpm or \\>120 bpm; Weight: decrease from baseline of \\<=-7 percentage (%) or increase from baseline of \\>=7%.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Any Concomitant Medications Usage', 'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '18', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'OG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}, {'value': '17', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Number of participants with any concomitant medications usage are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population included all enrolled participants in the current study B3461023 (Fx1A-303) and who had taken at least one dose of study medication.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'FG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'FG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'Treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '37'}, {'groupId': 'FG002', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '5'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Participant withdrew consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '3'}]}]}], 'recruitmentDetails': 'Participants enrolled in B3461023 had transthyretin amyloid polyneuropathy (ATTR-PN), had not undergone liver/heart transplantation, and completed either B3461021 (Fx-006 \\[NCT00791492\\]: extension to Fx-005 \\[NCT00409175\\]) or B3461022 (Fx1A-201 \\[NCT00630864\\]). Val30Met (V30M): valine replaced by methionine in position 30 of TTR protein; NonVal30Met (NonV30M): TTR mutations other than V30M.', 'preAssignmentDetails': 'Prior to B3461023, V30M participants completed 18 months (M) blinded treatment (placebo or tafamidis) in Fx-005 followed by 12M tafamidis in Fx-006; nonV30M participants completed 12M tafamidis in Fx1A-201. Baseline (except treatment-emergent adverse events) was last measurement prior to 1st dose in Fx-005 (V30M) or Fx1A-201 (NonV30M). V30M:data from Baseline to M18 from Fx-005; after M18 to M30 from Fx-006; after M30 from B3461023. NonV30M:Baseline to M12 from Fx1A-201, after M12 from B3461023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '38', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}, {'value': '93', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Val30Met: Tafamidis Then Tafamidis', 'description': 'Val30Met participants who received tafamidis in study B3461020 (Fx-005), continued the same in study B3461021 (Fx-006), received tafamidis 20 milligrams (mg) soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'BG001', 'title': 'Val30Met: Placebo Then Tafamidis', 'description': 'Val30Met participants who received placebo in study B3461020 (Fx-005) and assigned to receive tafamidis in study B3461021 (Fx-006) and study B3461023 (Fx1A-303), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'BG002', 'title': 'NonVal30Met: Tafamidis', 'description': 'NonVal30Met participants who received tafamidis in study B3461022 (Fx1A-201), received tafamidis 20 mg soft gelatin capsule orally once daily for up to 10 years from the date of enrollment in this study B3461023 (Fx1A-303) or until they had an access to tafamidis for ATTR-PN via prescription, upon regulatory approval in respective countries.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '76', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '46', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Caucasian', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '84', 'groupId': 'BG003'}]}, {'title': 'Latino American', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Afro-Caribbean', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2012-06-05', 'size': 5158281, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2021-07-07T08:45', 'hasProtocol': True}, {'date': '2014-09-11', 'size': 1754736, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2021-07-07T08:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 93}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-07', 'studyFirstSubmitDate': '2009-06-17', 'resultsFirstSubmitDate': '2021-07-07', 'studyFirstSubmitQcDate': '2009-06-17', 'lastUpdatePostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-07-07', 'studyFirstPostDateStruct': {'date': '2009-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-07-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Val30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 30', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 30', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 66', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 66', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'NonVal30Met Group: Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Baseline', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 12', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 12', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Neuropathy Impairment Score Lower Limb (NIS-LL) Score at Month 60', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 60', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'Val30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 30', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 30', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 66', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 66', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'NonVal30Met Group: Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Baseline', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 12', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 12', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 60', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 60', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 30', 'timeFrame': 'Month 30 (Baseline of B3461023)', 'description': 'KPS: used for rating participant activities of daily living on 11-step scale from 0-100, higher score=participant is better able to carry out daily activities. Score range: 100=normal no complaints; no disease evidence, 90=able to carry normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry on normal activity, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care, assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead. The lower the score the worse is survival for most serious illnesses. Data for KPS score was not collected in parent studies Fx-005 and Fx-006, therefore not reported for any time points from parent studies.'}, {'measure': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 66', 'timeFrame': 'Month 66 (Month 36 of B3461023)', 'description': 'KPS: used for rating participant activities of daily living on 11-step scale from 0-100, higher score=participant is better able to carry out daily activities. Score range: 100=normal no complaints; no disease evidence, 90=able to carry normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs/symptoms, 70=cares for self; unable to carry on normal activity, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care, assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead. The lower the score the worse is survival for most serious illnesses. Data for KPS score was not collected in parent studies Fx-005 and Fx-006, therefore not reported for any time points from parent studies.'}, {'measure': 'NonVal30Met Group: Karnofsky Performance Scale (KPS) Score at Baseline', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 12', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 12', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 60', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 60', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.'}, {'measure': 'Val30Met Group: Number of Participants by Ambulation Stage at Baseline', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on modified polyneuropathy disability (mPND) score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'Val30Met Group: Number of Participants by Ambulation Stage at Month 30', 'timeFrame': 'Month 30', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'Val30Met Group: Number of Participants by Ambulation Stage at Month 66', 'timeFrame': 'Month 66', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Baseline', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 12', 'timeFrame': 'Month 12', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 60', 'timeFrame': 'Month 60', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}], 'secondaryOutcomes': [{'measure': 'Val30Met Group: Change From B3461020 Baseline in NIS-LL Score at Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114 and 126', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114 and 126', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'Val30Met Group: NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Baseline', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114 and 126', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461020 (Fx-005), Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114 and 126', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in NIS-LL Score at Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. Total possible NIS-LL score range 0-88, high score=more impairment.'}, {'measure': 'NonVal30Met Group: NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Baseline', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201)', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in NIS-LL Subscales Scores: Muscle Weakness (MW), MW-Hip, MW-Knee, MW-Ankle, MW-Toe, NIS-LL Reflexes, NIS-LL Sensory at Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'timeFrame': 'Baseline (i.e. last measurement prior to first dose) of B3461022 (Fx1A-201), Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'description': 'NIS-LL: a subscale (of 37-item NIS questionnaire) that provided a total neuropathic deficit score for the lower limbs. It assess muscle weakness, reflexes, sensation; scored separately for left, right limbs with a total possible NIS-LL score range of 0 to 88, higher score=greater impairment. Components of muscle weakness (hip and knee flexion, hip and knee extension, ankle dorsiflexors, ankle plantar flexors, toe extensors, toe flexors) scored on scale 0 (normal) to 4 (paralysis), higher score=greater weakness. Components of reflexes (quadriceps femoris, triceps surae); sensation (touch pressure, pin-prick, vibration, joint position) scored 0=normal, 1=decreased, or 2=absent. NIS-LL Muscle Weakness score range is 0 to 64, high score=more impairment. NIS-LL Sensation score range is 0 to 16, high score=more impairment. NIS-LL Reflexes score range is 0 to 8, high score=more impairment.'}, {'measure': 'Val30Met Group: Change From B3461020 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114, 126, 138', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 6, 12, 18, 24, 42, 54, 78, 90, 102, 114, 126, 138', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'Val30Met Group: TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Baseline', 'timeFrame': 'Baseline of B3461020 (Fx-005)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).'}, {'measure': 'Val30Met:Change From Baseline in TQOL Subscale Scores:Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114, 126, 138', 'timeFrame': 'Baseline of B3461020 (Fx-005), Month 6, 12, 18, 24, 30, 42, 54, 66, 78, 90, 102, 114, 126 and 138', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Total Quality of Life (TQOL) Score Assessed Using Norfolk Quality of Life for Diabetic Neuropathy (QOL-DN) Questionnaire at Month 6, 24, 36, 48, 72, 84, 96, 108, 120', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 6, 24, 36, 48, 72, 84, 96, 108, 120', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire; assessed impact of DN on health related QOL of participants with DN. Scoring was based on 35 questions that yield a TQOL as well as 5 subscale scores: symptoms, activities of daily living (ADLs), large fiber neuropathy/physical functioning, small fiber neuropathy, and autonomic neuropathy. TQOL score: sum of all items, total possible score range= -2 to 138, where higher score=worse QOL.'}, {'measure': 'NonVal30Met Group: TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Baseline', 'timeFrame': 'Baseline of B3461022 (Fx1A-201)', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).'}, {'measure': 'NonVal30Met Group: Change From Baseline in TQOL Subscale Scores: Symptom, ADLs, Physical Functioning/Large Fiber Neuropathy, Small Fiber Neuropathy, Autonomic Neuropathy Assessed Using Norfolk QOL-DN at Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120', 'timeFrame': 'Baseline of B3461022 (Fx1A-201), Month 6, 12, 24, 36, 48, 60, 72, 84, 96, 108 and 120', 'description': 'Norfolk QOL-DN: 35-item participant-rated questionnaire to assess impact of DN on QOL; Item 1 to 7: scored as 1=symptom present, 0=symptom absent. Items 8 to 35: scored on 5-point Likert scale: 0=no problem to 4=severe problem (except item 32, where -1="somewhat better", -2=much better, 0=about the same, 1=somewhat worse, 2=much worse). Norfolk QOL-DN summarized in 5 domains (score range): physical functioning/large fiber neuropathy (-2 to 58), activities of daily living (ADLs) (0 to 20), symptoms (0 to 32), small fiber neuropathy (0 to 16), autonomic neuropathy (0 to 12); higher score=greater impairment, for each. Total score= -2 to 138 (higher score=worse QOL).'}, {'measure': 'Val30Met Group: Karnofsky Performance Scale (KPS) Score at Month 42, 54, 78, 90, 102, 114, 126 and 138', 'timeFrame': 'Baseline of B3461023, Month 42, 54, 78, 90, 102, 114, 126 and 138', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.'}, {'measure': 'NonVal30Met Group: Change From B3461022 Baseline in Karnofsky Performance Scale (KPS) Score at Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'timeFrame': 'Baseline of B3461022, Month 6, 24, 36, 48, 72, 84, 96, 108 and 120', 'description': 'Karnofsky performance scale was used for rating participant activities of daily living. It rated participant on 11-step scale ranged from 0-100, higher score=participant is better able to carry out daily activities. The lower the score, the worse the survival for most serious illnesses. Score range: 100=normal no complaints; no evidence of disease, 90=able to carry on normal activity; minor signs/symptoms of disease, 80=normal activity with effort; some signs or symptoms, 70=cares for self; unable to carry on normal activity or to do active work, 60=requires occasional assistance, but able to care for most personal needs, 50=requires considerable assistance and frequent medical care, 40=disabled; requires special care and assistance, 30=severely disabled; hospital admission is indicated although death not imminent, 20=very sick; hospital admission necessary, 10=moribund; fatal processes progressing rapidly and 0=dead, where lower score=worse survival for most serious illnesses.'}, {'measure': 'Val30Met Group: Number of Participants by Ambulation Stage at Week 12, Month 6, 9, 12, 18, 21, 24, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126, 129', 'timeFrame': 'Week 12, Month 6, 9, 12, 18, 21, 24, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126 and 129', 'description': 'Ambulatory status for each Val30Met participant was collected using ambulatory data collection forms in \\[B3461020 (Fx-005), B3461021 (Fx-006)\\] or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'NonVal30Met Group: Number of Participants by Ambulation Stage at Month 3, 6, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126, 129', 'timeFrame': 'Month 3, 6, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 63, 66, 69, 72, 75, 78, 81, 84, 87, 90, 93, 96, 99, 102, 105, 108, 111, 114, 117, 120, 123, 126 and 129', 'description': 'Ambulatory status for each NonVal30Met participant was collected using ambulatory data collection forms in B3461022 (Fx1A-201) or forms based on mPND score in B3461023 (after protocol amendment 1.1). The data were categorized to 3 ambulation stages: Stage 1 (normal), Stage 2 (some assistance required), or Stage 3 (not ambulatory).'}, {'measure': 'Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious AEs', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent AEs were events that emerged after enrollment in B3461023 (Fx1A-303) or which worsened during the course of B3461023 (Fx1A-303) relative to the pretreatment state. AEs included both SAEs and non-SAEs.'}, {'measure': 'Number of Participants With Abnormality in Physical Examinations', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': "Complete physical examination included examination of the general appearance, head and neck, ears, eyes, nose, throat, respiratory, genitourinary, endocrine, cardiovascular, abdomen, skin, musculoskeletal, neurological, immunologic/allergies, hematologic/lymphatic. Abnormality in physical findings were based on investigator's decision."}, {'measure': 'Number of Participants With Laboratory Test Abnormalities', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Abnormalities criteria: Serum chemistry (bilirubin\\>1.5\\*upper limit normal \\[ULN\\]; aspartate aminotransferase; alanine aminotransferase; alkaline phosphatase; gamma glutamyl transferase \\>3.0\\*ULN; albumin\\<0.8\\*lower limit normal \\[LLN\\],\\>1.2\\*ULN; blood urea nitrogen, creatinine\\>1.3\\*ULN; free T4, thyrotropin, thyroxine \\<0.8\\*LLN,\\>1.2\\*ULN; glucose\\<0.6\\*LLN,\\>1.5\\*ULN); Coagulation (prothrombin time, prothrombin int. normalized ratio \\>1.1\\*ULN); Hematology(basophils; eosinophils, monocytes \\>1.2\\*ULN; leukocytes \\<0.6\\*LLN,\\>1.5\\*ULN; lymphocytes, neutrophils \\<0.8\\*LLN, \\>1.2\\*ULN).'}, {'measure': 'Number of Participants With Electrocardiogram (ECG) Abnormalities', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': "Twelve-lead ECGs were obtained for all participants. Criteria for QT interval, Bazett's correction formula (QTcB) and Fridericia's correction formula (QTcF): greater than (\\>) 450-480 millisecond (msec), \\>480-500 msec and \\>500 msec. Findings were considered to be abnormal based on investigator's decision."}, {'measure': 'Number of Participants With Clinically Significant Changes From Baseline in Vital Signs', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Criteria for clinically significant changes: Supine and standing systolic blood pressure (BP): decrease from baseline of less than or equal to (\\<=) -20 millimeter of mercury (mmHg), increase from baseline of greater than or equal to (\\>=) 20 mmHg, systolic BP \\<90 mmHg or \\>180 mmHg; Supine and standing diastolic BP: decrease from baseline of \\<=-15 mmHg, increase from baseline of \\>= 15 mmHg, diastolic BP \\<50 mmHg or \\>105 mmHg; Supine and standing pulse rate: decrease from baseline of \\<=-15 beats per minute (bpm), increase from baseline of \\>=15 bpm, pulse rate \\<50 bpm or \\>120 bpm; Weight: decrease from baseline of \\<=-7 percentage (%) or increase from baseline of \\>=7%.'}, {'measure': 'Number of Participants With Any Concomitant Medications Usage', 'timeFrame': 'From Baseline (i.e., Day 0 of B3461023) up to 10 years', 'description': 'Number of participants with any concomitant medications usage are reported.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['ATTR-PN']}, 'referencesModule': {'references': [{'pmid': '32107748', 'type': 'DERIVED', 'citation': 'Merlini G, Coelho T, Waddington Cruz M, Li H, Stewart M, Ebede B. Evaluation of Mortality During Long-Term Treatment with Tafamidis for Transthyretin Amyloidosis with Polyneuropathy: Clinical Trial Results up to 8.5 Years. Neurol Ther. 2020 Jun;9(1):105-115. doi: 10.1007/s40120-020-00180-w. Epub 2020 Feb 27.'}, {'pmid': '31353964', 'type': 'DERIVED', 'citation': 'Huber P, Flynn A, Sultan MB, Li H, Rill D, Ebede B, Gundapaneni B, Schwartz JH. A comprehensive safety profile of tafamidis in patients with transthyretin amyloid polyneuropathy. Amyloid. 2019 Dec;26(4):203-209. doi: 10.1080/13506129.2019.1643714. Epub 2019 Jul 27.'}, {'pmid': '30558645', 'type': 'DERIVED', 'citation': 'Amass L, Li H, Gundapaneni BK, Schwartz JH, Keohane DJ. Influence of baseline neurologic severity on disease progression and the associated disease-modifying effects of tafamidis in patients with transthyretin amyloid polyneuropathy. Orphanet J Rare Dis. 2018 Dec 17;13(1):225. doi: 10.1186/s13023-018-0947-7.'}, {'pmid': '28758793', 'type': 'DERIVED', 'citation': 'Barroso FA, Judge DP, Ebede B, Li H, Stewart M, Amass L, Sultan MB. Long-term safety and efficacy of tafamidis for the treatment of hereditary transthyretin amyloid polyneuropathy: results up to 6 years. Amyloid. 2017 Sep;24(3):194-204. doi: 10.1080/13506129.2017.1357545. Epub 2017 Jul 31.'}, {'pmid': '27494299', 'type': 'DERIVED', 'citation': 'Waddington Cruz M, Amass L, Keohane D, Schwartz J, Li H, Gundapaneni B. Early intervention with tafamidis provides long-term (5.5-year) delay of neurologic progression in transthyretin hereditary amyloid polyneuropathy. Amyloid. 2016 Sep;23(3):178-183. doi: 10.1080/13506129.2016.1207163. Epub 2016 Aug 5.'}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=FX1A-303&StudyName=Safety%20And%20Efficacy%20Evaluation%20Of%20Fx-1006A%20In%20Subjects%20With%20Transthyretin%20Amyloidosis', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3, open-label study designed to obtain additional long-term safety and efficacy data for oral tafamidis (20 mg soft gelatin capsule) administered once daily (QD). In addition, this study continued to provide tafamidis to Val30Met subjects who had completed Protocol Fx-006 (a 1-year, open-label extension study to Protocol Fx-005 which was a randomized, double-blind, placebo-controlled, 18-month study to evaluate the safety and efficacy of tafamidis) or non-Val30Met subjects who had completed Protocol Fx1A-201 (a Phase 2, open-label study to evaluate TTR stabilization, safety, and tolerability of tafamidis) for up to 10 years or until subjects had access to tafamidis for ATTR-PN via prescription. Upon regulatory approval for the treatment of ATTR-PN in their respective country and access to prescription tafamidis, subjects may have been withdrawn from the study. Such subjects were considered study completers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion criteria:\n\n* Subject had successfully completed either Protocol Fx-006 or Fx-1A-201.\n* Male or female subjects with ATTR-PN who had not undergone liver or heart transplantation at time of enrollment.\n* If female, subject was post-menopausal, surgically sterilized, or willing to use an acceptable method of birth control\n\nKey Exclusion criteria:\n\n* Chronic use of non-protocol approved non-steroidal anti-inflammatory drugs (NSAIDs)\n* Pregnant or breast feeding female subjects.\n* Clinically significant medical condition that, in the opinion of the investigator, would place the subject at an increased risk to participate in the study.\n* An alanine aminotransferase (ALT) and aspartate aminotransferase (AST) value \\>3 × upper limit of normal (ULN) that, in the medical judgment of the investigator, was due to reduced liver function or active liver disease.\n* Sexually active males with partners of childbearing potential not using highly effective contraception or not agreeing to continue highly effective contraception for at least 3 months after last dose of study drug.'}, 'identificationModule': {'nctId': 'NCT00925002', 'briefTitle': 'Safety And Efficacy Evaluation Of Fx-1006A In Subjects With Transthyretin Amyloidosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'OPEN-LABEL SAFETY AND EFFICACY EVALUATION OF FX-1006A IN SUBJECTS WITH TRANSTHYRETIN (TTR) AMYLOIDOSIS', 'orgStudyIdInfo': {'id': 'FX1A-303'}, 'secondaryIdInfos': [{'id': 'B3461023', 'type': 'OTHER', 'domain': 'Alias Study Number'}, {'id': '2009-011535-12', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Open-Label', 'interventionNames': ['Drug: Tafamidis']}], 'interventions': [{'name': 'Tafamidis', 'type': 'DRUG', 'description': '20 mg oral Fx-1006A daily', 'armGroupLabels': ['Open-Label']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': 'C1428AQK', 'city': 'Buenos Aires', 'country': 'Argentina', 'facility': 'FLENI', 'geoPoint': {'lat': -34.61315, 'lon': -58.37723}}, {'zip': '21941-913', 'city': 'Rio de Jameiro', 'state': 'R.J.', 'country': 'Brazil', 'facility': 'Hospital Universitário Clementino Fraga Filho -HUCFF Universidade Federal do Rio de Janeiro'}, {'zip': '94010', 'city': 'Créteil', 'country': 'France', 'facility': "Centre d'Investigation Clinique", 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}, {'zip': '48149', 'city': 'Münster', 'country': 'Germany', 'facility': 'Universitatsklinikum Muenster', 'geoPoint': {'lat': 51.96236, 'lon': 7.62571}}, {'zip': '27100', 'city': 'Pavia', 'country': 'Italy', 'facility': 'Centro per lo Studio e la Cura delle Amiloidosi Sistemiche IRCCS - Policlinico San Matteo', 'geoPoint': {'lat': 45.19205, 'lon': 9.15917}}, {'zip': '1649-028', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Centro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4099-001', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Unidade Clinica de Paramiloidose Centro Hospitalar do Porto, EPE - Hospital Geral de Santo António', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '90185', 'city': 'Umeå', 'country': 'Sweden', 'facility': 'FAP-Teamet Familjar Amyloidos', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'ipdSharingStatementModule': {'url': 'https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests', 'ipdSharing': 'YES', 'description': "Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\\_trials/trial\\_data\\_and\\_results/data\\_requests."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}