Table 5 Adverse events (AEs) occurring during the whole study period
ASAQ (n = 184) | AL (n = 182) | |
|---|---|---|
Emergent AEs | 60 | 60 |
Treatment-related AEs (%)a | 32 (53.3) | 21 (35.0) |
AE of special interestb (%) | 4 (6.7)c | 4 (6.7)c |
Pregnancy (%) | 0 | 1 (1.7)c |
Serious AEs (%) | 1 (1.7) | 1 (1.7) |
Deaths | 0 | 0 |
AE intensity (%) | ||
Mild | 45 (75.0) | 44 (73.3) |
Moderate | 13 (21.7) | 15 (25.0) |
Severe | 2 (3.3) | 1 (1.7) |
Overall study (%) | ||
Patients with at least one AE | 47 (25.5) | 47 (25.8) |
Patients with at least one treatment-related AE | 26 (14.1) | 17 (9.3) |
Patients with at least one SAE and permanent study withdrawal due to AE | 1 (0.5) | 1 (0.5) |
First episode (%) | ||
Patients with at least one AE | 43 (23.4) | 41 (22.5) |
Patients with at least one SAE and permanent study withdrawal due to AE | 1 (0.5) | 1 (0.5) |
Second episode (%) | ||
Patients with at least one AE | 4 (14.8) | 8 (24.2) |