Overview of treatment-emergent adverse events (AEs) (safety population N = 768).
| . | Progesterone vaginal pessaries . | Progesterone vaginal gel . | Total . |
|---|---|---|---|
| . | N = 385 . | N = 383 . | N = 768 . |
| Number of patients with any AE | 168 (43.6%) | 171 (44.6%) | 339 (44.1%) |
| Number of patients with any serious AE | 6 (1.6%) | 13 (3.4%) | 19 (2.5%) |
| Number of patients with drug-related AEs | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with drug-related serious AEs | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Number of patients who discontinued due to AE | 19 (4.9%) | 12 (3.1%) | 31 (4.0%) |
| Intensity | |||
| Number of patients with mild AEs | 126 (32.7%) | 133 (34.7%) | 259 (33.7%) |
| Number of patients with moderate AEs | 40 (10.4%) | 36 (9.4%) | 76 (9.9%) |
| Number of patients with serious AEs | 2 (0.5%) | 2 (0.5%) | 4 (0.5%) |
| Related to study drug | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with mild AEs | 40 (10.4%) | 42 (11.0%) | 82 (10.7%) |
| Number of patients with moderate AEs | 17 (4.4%) | 13 (3.4%) | 30 (3.9%) |
| Number of patients with serious AEs | 1 (0.3%) | 0 (0.0%) | 1 (0.1%) |
| . | Progesterone vaginal pessaries . | Progesterone vaginal gel . | Total . |
|---|---|---|---|
| . | N = 385 . | N = 383 . | N = 768 . |
| Number of patients with any AE | 168 (43.6%) | 171 (44.6%) | 339 (44.1%) |
| Number of patients with any serious AE | 6 (1.6%) | 13 (3.4%) | 19 (2.5%) |
| Number of patients with drug-related AEs | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with drug-related serious AEs | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Number of patients who discontinued due to AE | 19 (4.9%) | 12 (3.1%) | 31 (4.0%) |
| Intensity | |||
| Number of patients with mild AEs | 126 (32.7%) | 133 (34.7%) | 259 (33.7%) |
| Number of patients with moderate AEs | 40 (10.4%) | 36 (9.4%) | 76 (9.9%) |
| Number of patients with serious AEs | 2 (0.5%) | 2 (0.5%) | 4 (0.5%) |
| Related to study drug | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with mild AEs | 40 (10.4%) | 42 (11.0%) | 82 (10.7%) |
| Number of patients with moderate AEs | 17 (4.4%) | 13 (3.4%) | 30 (3.9%) |
| Number of patients with serious AEs | 1 (0.3%) | 0 (0.0%) | 1 (0.1%) |
Overview of treatment-emergent adverse events (AEs) (safety population N = 768).
| . | Progesterone vaginal pessaries . | Progesterone vaginal gel . | Total . |
|---|---|---|---|
| . | N = 385 . | N = 383 . | N = 768 . |
| Number of patients with any AE | 168 (43.6%) | 171 (44.6%) | 339 (44.1%) |
| Number of patients with any serious AE | 6 (1.6%) | 13 (3.4%) | 19 (2.5%) |
| Number of patients with drug-related AEs | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with drug-related serious AEs | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Number of patients who discontinued due to AE | 19 (4.9%) | 12 (3.1%) | 31 (4.0%) |
| Intensity | |||
| Number of patients with mild AEs | 126 (32.7%) | 133 (34.7%) | 259 (33.7%) |
| Number of patients with moderate AEs | 40 (10.4%) | 36 (9.4%) | 76 (9.9%) |
| Number of patients with serious AEs | 2 (0.5%) | 2 (0.5%) | 4 (0.5%) |
| Related to study drug | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with mild AEs | 40 (10.4%) | 42 (11.0%) | 82 (10.7%) |
| Number of patients with moderate AEs | 17 (4.4%) | 13 (3.4%) | 30 (3.9%) |
| Number of patients with serious AEs | 1 (0.3%) | 0 (0.0%) | 1 (0.1%) |
| . | Progesterone vaginal pessaries . | Progesterone vaginal gel . | Total . |
|---|---|---|---|
| . | N = 385 . | N = 383 . | N = 768 . |
| Number of patients with any AE | 168 (43.6%) | 171 (44.6%) | 339 (44.1%) |
| Number of patients with any serious AE | 6 (1.6%) | 13 (3.4%) | 19 (2.5%) |
| Number of patients with drug-related AEs | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with drug-related serious AEs | 0 (0.0%) | 0 (0.0%) | 0 (0.0%) |
| Number of patients who discontinued due to AE | 19 (4.9%) | 12 (3.1%) | 31 (4.0%) |
| Intensity | |||
| Number of patients with mild AEs | 126 (32.7%) | 133 (34.7%) | 259 (33.7%) |
| Number of patients with moderate AEs | 40 (10.4%) | 36 (9.4%) | 76 (9.9%) |
| Number of patients with serious AEs | 2 (0.5%) | 2 (0.5%) | 4 (0.5%) |
| Related to study drug | 58 (15.1%) | 55 (14.4%) | 113 (14.7%) |
| Number of patients with mild AEs | 40 (10.4%) | 42 (11.0%) | 82 (10.7%) |
| Number of patients with moderate AEs | 17 (4.4%) | 13 (3.4%) | 30 (3.9%) |
| Number of patients with serious AEs | 1 (0.3%) | 0 (0.0%) | 1 (0.1%) |
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