Category of AE | Treatment period | Extension period | ||
---|---|---|---|---|
 | PRM | Placebo | PRM | Placebo |
No. of patients | 394 | 395 | 534 | 177 |
Any AE | 136 (34.5%) | 142 (35.9%) | 394 (73.8%) | 136 (76.8%) |
Any SAE | 1 (0.3%) | 3 (0.8%) | 15 (2.8%) | 9 (5.1%) |
   SAE leading to death | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) | 1 (0.6%) |
DAE | 9 (2.3%) | 8 (2.0%) | 30 (5.6%) | 12 (6.8%) |
Drug-related AE* | 17 (5.3%) | 19 (6.1%) | 56 (12.9%) | 24 (17.3%) |
Drug-related SAE* | 0 (0.0%) | 0 (0.0%) | 1 (0.2%) | 0 (0.0%) |