Table 4 Adverse events reported in ⩾2% of the subjects in any treatment group
Adverse event | AZL-M 40 | AZL-M 80 | RAM 10 |
---|---|---|---|
N=294 | N=293 | N=293 | |
Any adverse event | 112 (38.1) | 128 (43.7) | 113 (38.6) |
Related to study druga | 37 (12.6) | 39 (13.3) | 41 (14.0) |
Leading to discontinuationb | 7 (2.4) | 9 (3.1) | 14 (4.8) |
Serious adverse event | 8 (2.7) | 12 (4.1) | 6 (2.0) |
Deaths | 0 | 0 | 0 |
Events in ⩾2% of subjects | |||
Nasopharyngitis | 19 (6.5) | 13 (4.4) | 17 (5.8) |
Headache | 12 (4.1) | 10 (3.4) | 14 (4.8) |
Cough | 3 (1.0) | 4 (1.4) | 24 (8.2) |
Increase in blood creatine kinase | 6 (2.0) | 9 (3.1) | 4 (1.4) |
Dizziness | 8 (2.7) | 7 (2.4) | 4 (1.4) |
Back pain | 5 (1.7) | 11 (3.8) | 2 (0.7) |
Contusion | 7 (2.4) | 4 (1.4) | 1 (0.3) |
Hypotension | 4 (1.4) | 6 (2.0) | 2 (0.7) |
Increase in γ-glutamyl transferase | 7 (2.4) | 1 (0.3) | 3 (1.0) |