Table 3.
Summary of TEAEs related to study medication
Trifarotene N = 121 n (%) [events] |
Vehicle N = 121 n (%) [events] |
Overall N = 121 n (%) [events] |
||
---|---|---|---|---|
Subjects with any TEAE related to study drug | 6 (5.0) [8] | 2 (1.7) [2] | 9 (7.4) [12] | |
General disorders and administration site conditions | 4 (3.3) [5] | 2 (1.7) [2] | 6 (5.0) [8] | |
Pruritus | 1 (0.8) [1] | 1 (0.8) [1] | 2 (1.7) [2] | |
Skin tightness | 2 (1.7) [2] | 1 (0.8) [1] | 2 (1.7) [3] | |
Dermatitis contact | 0 | 0 | 1 (0.8) [1] | |
Erythema | 1 (0.8) [1] | 0 | 1 (0.8) [1] | |
Rash | 1 (0.8) [1] | 0 | 1 (0.8) [1] | |
General disorders and administration site conditions | 2 (1.7) [2] | 0 | 2 (1.7) [2] | |
Adverse reaction | 1 (0.8) [1] | 0 | 1 (0.8) [1] | |
Face edema | 1 (0.8) [1] | 0 | 1 (0.8) [1] | |
Injury, poisoning and procedural complications | 0 | 0 | 1 (0.8) [1] | |
Accidental exposure to product | 0 | 0 | 1 (0.8) [1] | |
Nervous system disorders | 1 (0.8) [1] | 0 | 1 (0.8) [1] | |
Burning sensation | 1 (0.8) [1] | 0 | 1 (0.8) [1] |