Adverse event category | Number (%) | Treatment difference (95% CI) | |||
---|---|---|---|---|---|
12 mg (N = 652) | 40 mg (N = 652) | Placebo (N = 653) | 12 mg vs. placebo | 40 mg vs. placebo | |
Hypopigmentation composite endpointa | 16 (2.5) | 16 (2.5) | 14 (2.1) | 0.31 (− 1.39, 2.04) | 0.31 (− 1.39, 2.04) |
Hypopigmentation event of clinical interest | 10 (1.5) | 9 (1.4) | 11 (1.7) | − 0.15 (− 1.64, 1.32) | − 0.3 (− 1.77, 1.12) |
Rash event of clinical interest | 30 (4.6) | 28 (4.3) | 8 (1.2) | 3.38 (1.63, 5.39) | 3.07 (1.36, 5.04) |
Severe rashb | 0 (0.0) | 0 (0.0) | 0 (0.0) | 0 | 0 |