Treatment-Emergent Adverse Events (All Causality)8
Characteristic |
Pooled Tafamidis (N=264) n (%) |
Placebo (N=177) n (%) |
|---|---|---|
| Number of TEAEs | 3174 | 2463 |
| Patients with ≥1 TEAE | 260 (98.5) | 175 (98.9) |
| Patients with ≥1 treatment-emergent SAE | 199 (75.4) | 140 (79.1) |
| Patients with ≥1 severe TEAE | 164 (62.1) | 114 (64.4) |
| Patients discontinued treatment due to a TEAE | 56 (21.2) | 51 (28.8) |
| Patients with dose reduced due to a TEAE | 2 (0.8) | 4 (2.3) |
| Patients with temporary discontinuation due to a TEAE | 53 (20.1) | 46 (26.0) |
• Frequency of AE’s was similar between those receiving 80 mg/day and 20 mg/day
• Discontinuations due to AE’s: 80 mg/day, 7%; 20 mg/day, 6%; and placebo, 6%
AE: adverse event; TEAE: treatment-emergent adverse event; SAE: serious adverse event.
Please see the PI Link below for additional safety information.
