Table 4 Safety information by treatment arm
Treatment | AL, n = 193 | ASAQ, n = 188 | P-value |
|---|---|---|---|
Total number of adverse events (AE) | 386 | 346 | – |
Mean AEs per patient | 2 | 1.8 | 0.20 |
Severity of adverse events (%) | |||
Mild | 83.4 | 84.7 | 0.642 |
Moderate | 13.7 | 13.9 | 0.956 |
Serious | 2.9 | 1.4 | 0.382 |
Relationship of events with the treatment (%) | |||
Definitely unrelated | 29.5 | 30.3 | 0.810 |
Unlikely | 54.2 | 55.2 | 0.774 |
Possible | 12.7 | 10.7 | 0.401 |
Probable | 3.6 | 3.8 | 0.926 |
Definitely related | 0 | 0 | – |