Parameter | Men n = 15 | Women n = 7 | Overall N = 22 |
---|---|---|---|
Patients with ≥ 1 TEAE, n (%) | 14 (93) | 7 (100) | 21 (96) |
Patients with ≥ 1 severe TEAE, n (%) | 4 (27) | 0 | 4 (18) |
Patients with ≥ 1 serious TEAE, n (%) | 4 (27) | 0 | 4 (18) |
Patients with ≥ 1 TEAE relateda to study treatment, n (%) | 5 (33) | 0 | 5 (23) |
Patients with ≥ 1 TEAE leading to study discontinuation, n (%) | 2 (13) | 0 | 2 (9)b |
Patients with ≥ 1 infusion-related reaction (IRR),c n (%) | 5 (33) | 0 | 5 (23)b |
TEAEs reported in > 2 patients | |||
Nasopharyngitis, n (%) | 5 (33) | 2 (29) | 7 (32) |
Headache, n (%) | 3 (20) | 2 (29) | 5 (23) |
Dyspnea, n (%) | 2 (13) | 1 (14) | 3 (14) |