Table 6 Serious treatment-emergent adverse events
Randomized, Placebo-Controlled Trials | Long-term Safety Trials | |||||
|---|---|---|---|---|---|---|
Atogepant | Placebo (n = 408) | Atogepant 60 mg once daily (n = 1228) | Standard Care (n = 196) | |||
10 mg once daily (n = 314) | 30 mg once daily (n = 411) | 60 mg once daily (n = 417) | ||||
Basal cell carcinoma | 0 | 0 | 0 | 0 | 5 (0.4) | 0 |
Abortion, induceda | 0 | 0 | 1 (0.3) | 0 | 2 (0.2) | 0 |
COVID-19 | 0 | 0 | 0 | 0 | 2 (0.2) | 0 |
Overdose | 0 | 0 | 1 (0.2) | 0 | 2 (0.2) | 0 |
Road traffic accident | 0 | 0 | 0 | 0 | 2 (0.2) | 0 |
Noncardiac chest pain | 0 | 0 | 0 | 0 | 1 (0.1) | 2 (1.0) |
Asthma | 1 (0.3) | 0 | 0 | 0 | 0 | 0 |
Brain injury | 0 | 0 | 0 | 1 (0.2) | 0 | 0 |
Cholecystitis | 1 (0.3) | 0 | 0 | 0 | 1 (0.1) | 0 |
Gastric ulcer hemorrhage | 0 | 0 | 0 | 1 (0.2) | 0 | 0 |
Hodgkin disease | 0 | 0 | 0 | 1 (0.2) | 0 | 0 |
Major depression | 0 | 0 | 1 (0.2) | 0 | 0 | 0 |
Migraine | 0 | 1 (0.2) | 0 | 0 | 1 (0.1) | 0 |
Negative-pressure pulmonary edema | 0 | 0 | 0 | 1 (0.2) | 0 | 0 |
Optic neuritis | 1 (0.3) | 0 | 0 | 0 | 0 | 0 |
Ureteritis | 0 | 1 (0.2) | 0 | 0 | 0 | 0 |
Ureterolithiasis | 0 | 0 | 0 | 1 (0.2) | 1 (0.1) | 0 |