Table 4.
Frequency of treatment emergent adverse events (TEAEs) in the safety population
| Topical finasteride (N = 181) | Placebo (N = 181) | Oral finasteride (N = 84) | Total (N = 446) | |
|---|---|---|---|---|
| Patients with TEAEs, n (%) | 75 (41.4) | 76 (42.0) | 41 (48.8) | 192 (43.0) |
| Mild | 59 (32.6) | 60 (33.1) | 33 (39.3) | 152 (34.1) |
| Moderate | 32 (17.7) | 31 (17.1) | 19 (22.6) | 82 (18.4) |
| Severe† | 4 (2.2) | 3 (1.7) | 2 (2.4) | 9 (2.0) |
| Patients with TEAEs leading to study discontinuation, n (%) | 5 (2.8) | 4 (2.2) | 6 (7.1) | 15 (3.4) |
| Patients with treatment‐related TEAEs‡, n (%) | 18 (9.9) | 12 (6.6) | 10 (11.9) | 40 (9.0) |
| Patients with treatment‐related TEAEs leading to study discontinuation | 4 (2.2) | 2 (1.1) | 2 (2.4) | 8 (1.8) |
| Patients with treatment‐emergent serious AEs | 4 (2.2) | 5 (2.8) | 1 (1.2) | 10 (2.2) |
| Patients with treatment‐related serious AEs | 0 | 0 | 0 | 0 |
†
Cases of unknown intensity were assumed to be severe.
‡
Includes AEs considered related or possibly related to study drug and AEs with unknown or missing relationship to study drug.