Table 2.
Overview of TEAEs and TEAEs occurring in >15% of patients by preferred term (combination safety set).
| Patients, n (%) | Berzosertib + cisplatin (all doses), N = 30 | |
|---|---|---|
| Any grade | Grade ≥ 3 | |
| TEAEs | ||
| AEs | 29 (96.7) | 21 (70.0) |
| Serious AEs | 11 (36.7) | 9 (30.0) |
| Treatment-related AEs | ||
| AEs | 28 (93.3) | 12 (40.0) |
| Serious AEs | 3 (10.0) | 1 (3.3) |
| AEs leading to study drug discontinuation | 8 (26.7) | 4 (13.3) |
| DLTs | 2 (6.7) | |
| TEAEs occurring in ≥15% of patients | Any grade | Grade 3–4a |
| Fatigue | 17 (56.7) | 0 |
| Anaemia | 15 (50.0) | 5 (16.7) |
| Nausea | 15 (50.0) | 2 (6.7) |
| Constipation | 11 (36.7) | 0 |
| Neutropenia | 10 (33.3) | 6 (20.0) |
| Vomiting | 9 (30.0) | 0 |
| Abdominal pain | 7 (23.3) | 1 (3.3) |
| Diarrhoea | 7 (23.3) | 0 |
| Hyponatraemia | 7 (23.4) | 2 (6.7) |
| Decreased appetite | 6 (20.0) | 0 |
| Headache | 6 (20.0) | 1 (3.3) |
| Tinnitus | 6 (20.0) | 0 |
| ALT increased | 5 (16.7) | 2 (6.7) |
| AST increased | 5 (16.7) | 1 (3.3) |
| Dizziness | 5 (16.7) | 0 |
| Flushing | 5 (16.7) | 0 |
| Hypokalaemia | 5 (16.7) | 1 (3.3) |
| Hypotension | 4 (16.7) | 1 (3.3) |
AE adverse event, ALT alanine aminotransferase, AST aspartate aminotransferase, DLT dose-limiting toxicity, TEAE treatment-emergent adverse event.
aNo grade 5 TEAE occurred.