Table 3.
Treatment-emergent adverse events by preferred term reported in ≥10% of total patients, intent-to-treat population, (A) Phase 1a; (B) Phase 1b and Phase 2.
| (A) | |||||
|---|---|---|---|---|---|
| Preferred term, n (%) | BGB-A333 450 mg (n = 3) | BGB-A333 900 mg (n = 3) | BGB-A333 1350 mg (n = 6) | BGB-A333 1800 mg (n = 3) | Total (N = 15) |
| Any TEAE | 1 (33.3) | 2 (66.7) | 6 (100.0) | 3 (100.0) | 12 (80.0) |
| Fatigue | 0 (0.00) | 1 (33.3) | 1 (16.7) | 2 (66.7) | 4 (26.7) |
| Nausea | 1 (33.3) | 0 (0.0) | 3 (50.0) | 0 (0.0) | 4 (26.7) |
| Vomiting | 0 (0.0) | 1 (33.3) | 3 (50.0) | 0 (0.0) | 4 (26.7) |
| Myalgia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 2 (66.7) | 3 (20.0) |
| Abdominal pain upper | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (33.3) | 2 (13.3) |
| Anaemia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Back pain | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Cough | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Diarrhoea | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (33.3) | 2 (13.3) |
| Headache | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Hypercalcaemia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Lower respiratory tract infection | 0 (0.0) | 0 (0.0) | 2 (33.3) | 0 (0.0) | 2 (13.3) |
| Oral candidiasis | 0 (0.0) | 0 (0.0) | 1 (16.7) | 1 (33.3) | 2 (13.3) |
| Pelvic pain | 1 (33.3) | 0 (0.0) | 1 (16.7) | 0 (0.0) | 2 (13.3) |
| Pyrexia | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Rash | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| Rash, macro-papular | 0 (0.0) | 1 (33.3) | 0 (0.0) | 1 (33.3) | 2 (13.3) |
| (B) | |||
|---|---|---|---|
| Preferred term, n (%) | Phase 1b BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | Phase 2 UC cohort BGB-A333 1350 mg + tislelizumab 200 mg (N = 12) | Total (N = 24) |
| Any TEAE | 12 (100.0) | 12 (100.0) | 24 (100.0) |
| Diarrhoea | 4 (33.3) | 2 (16.7) | 6 (25.0) |
| Anaemia | 3 (25.0) | 1 (8.3) | 4 (16.7) |
| Fatigue | 2 (16.7) | 2 (16.7) | 4 (16.7) |
| Nausea | 4 (33.3) | 0 (0.0) | 4 (16.7) |
| Pain in extremity | 2 (16.7) | 2 (16.7) | 4 (16.7) |
| Asthenia | 0 (0.00) | 3 (25.0) | 3 (12.5) |
| Coug | 3 (25.0) | 0 (0.00) | 3 (12.5) |
| Insomnia | 1 (8.3) | 2 (16.7) | 3 (12.5) |
| Musculoskeletal chest pain | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| Pruritis | 2 (16.7) | 1 (8.3) | 3 (12.5) |
| Rash, maculo-papular | 2 (16.7) | 1 (8.3) | 3 (12.5) |
AEs were coded using MedDRA Version 23.0 and graded using CTCAE Version 4.03.
For each row category, a patient with two or more AEs in that category was counted only once.
AE adverse event, CTCAE Common Terminology Criteria for Adverse Events, MedDRA Medical Dictionary for Regulatory Activities, TEAE treatment-emergent adverse event, UC urothelial carcinoma.