Safety1

TEAEs from the ATTR-ACT LTE Post-hoc Interim Safety Analysis10

AEs, n (%) Continuous tafamidis (n=164)
Any AE's
  • 158 (96.3)
Cardiac disorders
  • Cardiac failure
  • Atrial fibrillation
  • Cardiac failure acute
  • Cardiac failure congestive
  • Ventricular tachycardia
  • 106 (64.6)
  • 32 (19.5)
  • 31 (18.9)
  • 15 (9.1)
  • 15 (9.1)
  • 14 (8.5)
Infections and infestations
  • 93 (56.7)
Respiratory, thoracic, and mediastinal disorders
  • Pleural effusion
  • Dyspnea
  • Cough
  • Epistaxis
  • 83 (50.6)
  • 31 (18.9)
  • 29 (17.7)
  • 28 (17.1)
  • 13 (7.9)
Injury, poisoning, and procedural complications
  • 79 (48.2)
Gastrointestinal disorders
  • 78 (47.6)
General disorders and administration site conditions
  • Peripheral edema
  • Fatigue
  • Asthenia
  • 75 (45.7)
  • 23 (14.0)
  • 21 (12.8)
  • 14 (8.5)
Nervous system disorders
  • 72 (43.9)
Metabolism and nutrition disorders
  • 72 (43.9)
Musculoskeletal and connective tissue disorders
  • 71 (43.3)
Renal and urinary disorders
  • 63 (38.4)
Skin and subcutaneous tissue disorders
  • 59 (36.0)

AE: adverse event; ATTR-ACT: Transthyretin Amyloidosis Cardiomyopathy Clinical Trial; LTE: long-term extension; TEAE: treatment-emergent adverse event.

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