Table 2. Summary of Adverse Events During Treatment.
Adverse event | Mavacamten (n = 54) | Placebo (n = 27) |
---|---|---|
Total number of TEAEs | 165 | 82 |
Patients with ≥1 TEAE, No. (%) | 45 (83.3) | 24 (88.9) |
Patients with ≥1 treatment-related TEAE, No. (%) | 11 (20.4) | 9 (33.3) |
Total No. of TESAEs | 8 | 0 |
Patients with ≥1 TESAE, No. (%) | 4 (7.4) | 0 |
Atrial fibrillation | 2 (3.7) | 0 |
Atrial flutter | 1 (1.9) | 0 |
Sinus arrest | 1 (1.9) | 0 |
Sinus node dysfunction | 1 (1.9) | 0 |
Hypotension | 1 (1.9) | 0 |
Hemorrhoids | 1 (1.9) | 0 |
Ankle fracture | 1 (1.9) | 0 |
Patients with ≥1 related TESAE, No. (%) | 0 | 0 |
Patients with ≥1 AESI, No. (%) | 1 (1.9) | 0 |
Abbreviations: AESI, adverse event of special interest; TEAE, treatment-emergent adverse event; TESAE, treatment-emergent serious adverse event.