Table 2.
Overall summary of adverse events (Safety Population).
| Number of | Low Dose N = 51 n (%) |
Medium Dose N = 51 n (%) |
High Dose N = 51 n (%) |
Overall N = 153 n (%) |
|---|---|---|---|---|
| Participants with any AE until Day 36 | 45 (88.2) | 40 (78.4) | 45 (88.2) | 130 (85.0) |
| Participants with any AE until day of data cut for Day 106 analysis | 45 (88.2) | 40 (78.4) | 46 (90.2) | 131 (85.6) |
| Participants with any treatment related AE until Day 36 | 43 (84.3) | 40 (78.4) | 43 (84.3) | 126 (82.4) |
| Participants with any treatment related AE until day of data cut for Day 106 analysis | 43 (84.3) | 40 (78.4) | 43 (84.3) | 126 (82.4) |
| Participants with any serious AE until Day 36 | 0 | 1 (2.0) | 0 | 1 (0.7) |
| Participants with any serious AE until day of data cut for Day 106 analysis | 0 | 1 (2.0) | 0 | 1 (0.7) |
| Participants with any medically attended AE until Day 36 | 1 (2.0) | 3 (5.9) | 1 (2.0) | 5 (3.3) |
| Participants with any medically attended AE until day of data cut for Day 106 analysis | 3 (5.9) | 6 (11.8) | 3 (5.9) | 12 (7.8) |
| Participants with any solicited AE until Day 36 | 43 (84.3) | 39 (76.5) | 43 (84.3) | 125 (81.7) |
| Participants with any solicited AE until day of data cut for Day 106 analysis | 43 (84.3) | 39 (76.5) | 43 (84.3) | 125 (81.7) |
AE=Adverse Event.