Table 2. Summary of Adverse Events .
Event | Treatment group, No. (%) | ||
---|---|---|---|
Placebo (n = 78) | Abrocitinib | ||
100 mg (n = 158) | 200 mg (n = 155) | ||
Deaths | 0 | 1 (0.6) | 0 |
Serious adverse events of any cause | 1 (1.3) | 5 (3.2) | 2 (1.3) |
Most frequently reported TEAEs of any cause (≥3% in any treatment group) | |||
Nausea | 2 (2.6) | 12 (7.6) | 22 (14.2) |
Nasopharyngitis | 5 (6.4) | 20 (12.7) | 12 (7.7) |
Headache | 2 (2.6) | 9 (5.7) | 12 (7.7) |
Upper respiratory tract infection | 3 (3.8) | 14 (8.9) | 5 (3.2) |
Dermatitis atopic | 12 (15.4) | 9 (5.7) | 6 (3.9) |
Acne | 0 | 2 (1.3) | 9 (5.8) |
Vomiting | 1 (1.3) | 2 (1.3) | 8 (5.2) |
Upper abdominal pain | 0 | 2 (1.3) | 6 (3.9) |
Blood creatine phosphokinase increased | 2 (2.6) | 3 (1.9) | 5 (3.2) |
Folliculitis | 2 (2.6) | 0 | 5 (3.2) |
Thrombocytopenia | 0 | 0 | 5 (3.2) |
Abbreviation: TEAE, treatment-emergent adverse event.