Table 4 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) | ||||
AEs (≥ 5% of atogepant-treated participants), n (%) | ||||||
Upper respiratory tract infection | 15 (4.8) | 27 (6.6) | 19 (4.6) | 25 (6.1) | 94 (7.7) | 24 (12.2) |
Mild | 7 (2.2) | 14 (3.4) | 11 (2.6) | 12 (2.9) | 44 (3.6) | 16 (8.2) |
Moderate | 8 (2.5) | 13 (3.2) | 8 (1.9) | 13 (3.2) | 50 (4.1) | 8 (4.1) |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
Constipation | 19 (6.1) | 26 (6.3) | 25 (6.0) | 5 (1.2) | 62 (5.0) | 6 (3.1) |
Mild | 16 (5.1) | 19 (4.6) | 17 (4.1) | 3 (0.7) | 41 (3.3) | 4 (2.0) |
Moderate | 2 (0.6) | 7 (1.7) | 8 (1.9) | 2 (0.5) | 20 (1.6) | 2 (1.0) |
Severe | 1 (0.3) | 0 | 0 | 0 | 1 (0.1) | 0 |
Nasopharyngitis | 7 (2.2) | 19 (4.6) | 22 (5.3) | 12 (2.9) | 57 (4.6) | 10 (5.1) |
Mild | 7 (2.2) | 15 (3.6) | 20 (4.8) | 9 (2.2) | 36 (2.9) | 7 (3.6) |
Moderate | 0 | 4 (1.0) | 2 (0.5) | 3 (0.7) | 21 (1.7) | 3 (1.5) |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
Nausea | 16 (5.1) | 23 (5.6) | 36 (8.6) | 13 (3.2) | 57 (4.6) | 12 (6.1) |
Mild | 14 (4.5) | 16 (3.9) | 24 (5.8) | 10 (2.5) | 44 (3.6) | 7 (3.6) |
Moderate | 2 (0.6) | 6 (1.5) | 11 (2.6) | 3 (0.7) | 13 (1.1) | 5 (2.6) |
Severe | 0 | 1 (0.2) | 1 (0.2) | 0 | 0 | 0 |
Urinary tract infection | 5 (1.6) | 20 (4.9) | 14 (3.4) | 12 (2.9) | 64 (5.2) | 9 (4.6) |
Mild | 3 (1.0) | 11 (2.7) | 7 (1.7) | 4 (1.0) | 32 (2.6) | 4 (2.0) |
Moderate | 2 (0.6) | 9 (2.2) | 7 (1.7) | 8 (2.0) | 32 (2.6) | 4 (2.0) |
Severe | 0 | 0 | 0 | 0 | 0 | 1 (0.5) |
AEs of interest, n (%) | ||||||
Weight decrease | 1 (0.3) | 0 | 4 (1.0) | 3 (0.7) | 32 (2.6) | 3 (1.5) |
Mild | 1 (0.3) | 0 | 2 (0.5) | 1 (0.2) | 26 (2.1) | 2 (1.0) |
Moderate | 0 | 0 | 2 (0.5) | 2 (0.5) | 6 (0.5) | 1 (0.5) |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
Weight increase | 2 (0.6) | 0 | 2 (0.5) | 5 (1.2) | 15 (1.2) | 11 (5.6) |
Mild | 1 (0.3) | 0 | 2 (0.5) | 4 (1.0) | 11 (0.9) | 9 (4.6) |
Moderate | 1 (0.3) | 0 | 0 | 1 (0.2) | 4 (0.3) | 2 (1.0) |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
ALT increase | 5 (1.6) | 4 (1.0) | 6 (1.4) | 9 (2.2) | 16 (1.3) | 4 (2.0) |
Mild | 1 (0.3) | 1 (0.2) | 4 (1.0) | 5 (1.2) | 8 (0.7) | 2 (1.0) |
Moderate | 4 (1.3) | 2 (0.5) | 0 | 4 (1.0) | 6 (0.5) | 1 (0.5) |
Severe | 0 | 1 (0.2) | 2 (0.5) | 0 | 2 (0.2) | 1 (0.5) |
AST increase | 4 (1.3) | 4 (1.0) | 4 (1.0) | 8 (2.0) | 20 (1.6) | 5 (2.6) |
Mild | 2 (0.6) | 2 (0.5) | 1 (0.2) | 3 (0.7) | 10 (0.8) | 1 (0.5) |
Moderate | 2 (0.6) | 2 (0.5) | 2 (0.5) | 5 (1.2) | 8 (0.7) | 4 (2.0) |
Severe | 0 | 0 | 1 (0.2) | 0 | 2 (0.2) | 0 |
Hypertension | 1 (0.3) | 4 (1.0) | 0 | 0 | 23 (1.9) | 2 (1.0) |
Mild | 1 (0.3) | 0 | 0 | 0 | 10 (0.8) | 2 (1.0) |
Moderate | 0 | 4 (1.0) | 0 | 0 | 13 (1.1) | 0 |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |
Other cardiac disordera | 4 (1.3) | 9 (2.2) | 3 (0.7) | 4 (1.0) | 16 (1.3) | 5 (2.6) |
Mild | 3 (1.0) | 9 (2.2) | 2 (0.5) | 2 (0.5) | 9 (0.7) | 5 (2.6) |
Moderate | 1 (0.3) | 0 | 1 (0.2) | 2 (0.5) | 7 (0.6) | 0 |
Severe | 0 | 0 | 0 | 0 | 0 | 0 |