Table 2.
Overall safety summary and frequent treatment-emergent adverse events (all causalities) for the placebo-controlled cohort
| Placebo N = 342 n (%) |
Abrocitinib 100 mg N = 608 n (%) |
Abrocitinib 200 mg N = 590 n (%) |
|
|---|---|---|---|
| Patients evaluable for AEs | 342 | 608 | 590 |
| Number of AEs | 360 | 816 | 921 |
| Patients with AEs | 188 (55.0) | 371 (61.0) | 403 (68.3) |
| Patients with SAEs | 11 (3.2) | 19 (3.1) | 11 (1.9) |
| Patients with severe AEs | 20 (5.8) | 29 (4.8) | 19 (3.2) |
| Deaths | 0 | 1 (0.2) | 2 (0.3) |
| Most frequent adverse events | |||
| Nausea | 7 (2.0) | 37 (6.1) | 86 (14.6) |
| Nasopharyngitis | 27 (7.9) | 75 (12.3) | 51 (8.6) |
| Headache | 12 (3.5) | 36 (5.9) | 46 (7.8) |
| Upper respiratory tract infection | 19 (5.6) | 40 (6.6) | 30 (5.1) |
| Acne | 0 | 10 (1.6) | 28 (4.7) |
| Dermatitis atopic | 37 (10.8) | 45 (7.4) | 24 (4.1) |
| Vomiting | 3 (0.9) | 9 (1.5) | 19 (3.2) |
| Blood creatine phosphokinase increased | 5 (1.5) | 14 (2.3) | 17 (2.9) |
| Dizziness | 3 (0.9) | 11 (1.8) | 17 (2.9) |
| Herpes simplex | 3 (0.9) | 10 (1.6) | 17 (2.9) |
| Diarrhea | 10 (2.9) | 10 (1.6) | 16 (2.7) |
| Urinary tract infection | 4 (1.2) | 10 (1.6) | 13 (2.2) |
| Folliculitis | 7 (2.0) | 6 (1.0) | 10 (1.7) |
AE adverse event, SAE serious adverse event