Table 3.
Participants with AEs
| Participants with event, n (%) |
Atogepant 170 mg q.d. (n = 23) |
Placebo q.d. (n = 11) |
|---|---|---|
| At least 1 AE | 20 (87.0) | 8 (72.7) |
| SAE (subarachnoid hemorrhage due to bicycle accident) | 1 (4.3) | 0 |
| AE leading to trial discontinuation (racing thoughts, subarachnoid hemorrhage due to bicycle accident) | 2 (8.7) | 0 |
| AEs occurring in ≥ 2 participants in a treatment group, n (%) | ||
| Fatigue | 11 (47.8) | 4 (36.4) |
| Headache | 7 (30.4) | 3 (27.3) |
| Dizziness | 5 (21.7) | 1 (9.1) |
| Appetite decreased | 5 (21.7) | 0 |
| Erythema | 3 (13.0) | 1 (9.1) |
| Nausea | 3 (13.0) | 1 (9.1) |
| Vessel puncture site pain | 3 (13.0) | 1 (9.1) |
| Back pain | 3 (13.0) | 0 |
| Pruritus | 3 (13.0) | 0 |
| Hematoma | 2 (8.7) | 2 (18.2) |
| Oropharyngeal pain | 2 (8.7) | 2 (18.2) |
| Scratch | 2 (8.7) | 1 (9.1) |
| Abdominal discomfort | 2 (8.7) | 0 |
| Chills | 2 (8.7) | 0 |
| Constipation | 2 (8.7) | 0 |
| Diarrhea | 2 (8.7) | 0 |
| Feeling hot | 2 (8.7) | 0 |
| Musculoskeletal pain | 2 (8.7) | 0 |
| Neck pain | 2 (8.7) | 0 |
| Weight decreased | 2 (8.7) | 0 |
AE, adverse event; SAE, serious adverse event.