Table 4.
Summary of AEs in the phase 3 trial
| Placebo (n=510) | RTB101 (n=511) | ||
|---|---|---|---|
| Any AE | 371 (73%) | 386 (76%) | |
| AE by maximum severity | |||
| Grade 1 (mild) | 207 (41%) | 213 (42%) | |
| Grade 2 (moderate) | 139 (27%) | 149 (29%) | |
| Grade 3 (severe) | 23 (5%) | 21 (4%) | |
| Grade 4 (severe and life-threatening) | 2 (<1%) | 2 (<1%) | |
| Grade 5 (fatal) | 0 | 1 (<1%) | |
| Study-drug related AE | 125 (25%) | 117 (23%) | |
| Serious AE | 32 (6%) | 31 (6%) | |
| Study-drug related serious AE | 1 (<1%) | 0 | |
| AE leading to study drug discontinuation | 13 (3%) | 18 (4%) | |
| AE leading to study withdrawal | 10 (2%) | 10 (2%) | |
| AE leading to death | 0 | 1 (<1%) | |
Data are n (%). Table shows patients with at least one AE.