Table 3.
AEs (safety populationa) in cohort 2
| Placebo (n = 22)b | Fenebrutinib | All patients (n = 93) | |||
|---|---|---|---|---|---|
| 50 mg daily (n = 23) | 150 mg daily (n = 24) | 200 mg twice daily (n = 24)b | |||
| At least one AE, n (%) | 12 (54) | 14 (61) | 16 (67) | 14 (58) | 56 (60) |
| Overall total number of AEs | 33 | 38 | 35 | 41 | 147 |
| Any AE leading to discontinuation of the study drug, n (%) | 1 (4) | 2 (9) | 0 | 1 (4) | 4 (4) |
| Early withdrawal from the study treatment period due to an AE, n (%) | 1 (4) | 1 (4) | 0 | 1 (4) | 3 (3) |
| Any SAE, n (%) | 0 | 0 | 0 | 0 | 0 |
| Death, n (%) | 0 | 0 | 0 | 0 | 0 |
| Any AE suspected to be caused by the study drug, n (%) | 6 (27) | 4 (17) | 5 (21) | 6 (25) | 21 (23) |
| Any severe AE, n (%) | 2 (9) | 1 (4) | 1 (4) | 1 (4) | 5 (5) |
| Most common AEs (preferred term) in ≥3 patients overall, n (%) | |||||
| Urticaria | 2 (9) | 3 (13) | 4 (17) | 5 (21) | 14 (15) |
| Nasopharyngitis | 1 (4) | 3 (13) | 3 (13) | 3 (12) | 10 (11) |
| Headache | 2 (9) | 0 | 1 (4) | 3 (12) | 6 (6) |
| Nausea | 0 | 1 (4) | 2 (8) | 2 (8) | 5 (5) |
| Chronic spontaneous urticaria | 1 (4) | 1 (4) | 2 (8) | 0 | 4 (4) |
| Urinary tract infection | 0 | 1 (4) | 2 (8) | 1 (4) | 4 (4) |
| ALT increased | 0 | 0 | 1 (4) | 3 (12) | 4 (4) |
| AST increased | 0 | 0 | 1 (4) | 2 (8) | 3 (3) |
| Upper respiratory tract infection | 1 (4) | 0 | 0 | 2 (8) | 3 (3) |
| Diarrhea | 2 (9) | 0 | 1 (4) | 0 | 3 (3) |
| Fatigue | 2 (9) | 0 | 1 (4) | 0 | 3 (3) |
aThe safety population was defined according to the treatment actually received.
bOne patient who was randomized to the placebo group and received placebo was placed in the 200 mg twice daily group for safety analyses due to a data entry error.
AEs were coded using the Medical Dictionary for Regulatory Activities v.22.1. ALT, alanine aminotransferase; AST, aspartate aminotransferase.