Table 2 Description of the adverse events (AEs) possibly related to treatment, and of the subjects having developed such AEs in the three treatment arms
Adverse events (AE) | PLA (N = 30) | LEV-3 (N = 33) | LEV-5 (N = 29) | P value |
|---|---|---|---|---|
Total No. of AEs | 23 | 29 | 17 | |
No. (%) of subjects with at least one AE | 18 (60.0) | 24 (72.7) | 12 (41.4) | 0.047a |
Median onset, days b (range) | 1.5 (0–12) | 0 (0–3) | 1 (0–12) | 0.132c |
Mean onset, days b (SD) | 2.2 (3.4) | 0.7 (1.1) | 1.9 (3.3) | |
Median duration, days b (IQR) | 0.5 (0–5) | 0 (0–3) | 2 (0–10) | 0.182c |
Severity of AEs | ||||
Grade 1 AE | 13 (72.2) | 17 (70.8) | 9 (75.0) | 0.999a |
Grade 2 AE | 5 (27.8) | 7 (29.2) | 3 (25.0) | |
Grade 3 & 4 AE | 0 | 0 | 0 | |
