Table 2 Treatment-emergent adverse events
Placebo (n = 65) | AZL-M 40 mg (n = 132) | AZL-M 80 mg (n = 130) | Total (N = 327) | ||||
|---|---|---|---|---|---|---|---|
Events, n | Patients, n (%) | Events, n | Patients, n (%) | Events, n | Patients, n (%) | Patients, n (%) | |
Total treatment-emergent AEs | 19 | 13 (20.0) | 30 | 20 (15.2) | 40 | 29 (22.3) | 62 (19.0) |
Related to study drug | 1 | 1 (1.5) | 2 | 2 (1.5) | 7 | 6 (4.6) | 9 (2.8) |
Not related to study drug | 18 | 12 (18.5) | 28 | 18 (13.6) | 33 | 23 (17.7) | 53 (16.2) |
Treatment-emergent AE severity | |||||||
Mild | 16 | 11 (16.9) | 29 | 19 (14.4) | 25 | 21 (16.2) | 51 (15.6) |
Moderate | 2 | 1 (1.5) | 1 | 1 (0.8) | 14 | 7 (5.4) | 9 (2.8) |
Severe | 1 | 1 (1.5) | 0 | 0 | 1 | 1 (0.8) | 2 (0.6) |
Treatment-emergent AEs leading to discontinuation | 1 (1.5) | 3 (2.3) | 2 (1.5) | 6 (1.8) | |||
Serious AEs | 0 | 0 | 0 | 0 | 6 | 2 (1.5) | 2 (0.6) |
Deaths | 0 | 0 | 0 | 0 | |||
Treatment-emergent AEs related to study drug | 1 (1.5) | 2 (1.5) | 6 (4.6) | 9 (2.8) | |||
Dizziness | 0 | 1 (0.8) | 5 (3.8) | 6 (1.8) | |||
Headache | 0 | 1 (0.8) | 1 (0.8) | 2 (0.6) | |||
Hypotension | 0 | 0 | 1 (0.8) | 1 (0.3) | |||
Dyspepsia | 1 (1.5) | 0 | 0 | 1 (0.3) | |||