Table 5.
Overview of TEAEs for berzosertib and cisplatin (safety analysis set, N = 47).
| Patients, N (%) | Berzosertib + Cisplatin Any grade |
Berzosertib + Cisplatin Grade ≥3 |
|---|---|---|
| N = 47 | N = 47 | |
| TEAE | 47 (100) | 36 (76.6) |
| Berzosertib-related TEAE | 45 (95.7) | 27 (57.4) |
| Cisplatin or carboplatin-related TEAE | 47 (100) | 31 (66.0) |
| Berzosertib or cisplatin or carboplatin-related TEAE | 47 (100) | 32 (68.1) |
| TEAEs occurring in ≥20% of patients | ||
| Nausea | 39 (83.0) | 4 (8.5) |
| Fatigue | 32 (68.1) | 1 (2.1) |
| Neutropenia | 29 (61.7) | 18 (38.3) |
| Vomiting | 28 (59.6) | 6 (12.8) |
| Tinnitus | 21 (44.7) | 0 |
| Anemia | 19 (40.4) | 12 (25.5) |
| Headache | 18 (38.3) | 0 |
| Diarrhea | 16 (34.0) | 0 |
| Constipation | 14 (29.8) | 0 |
| Dizziness | 11 (23.4) | 0 |
| Decreased appetite | 10 (21.3) | 0 |
| Serious TEAE | 15 (31.9) | 13 (27.7) |
| Berzosertib-related serious TEAE | 10 (21.3) | 8 (17.0) |
| Cisplatin or carboplatin-related serious TEAE | 10 (21.3) | 8 (17.0) |
| Berzosertib or cisplatin or carboplatin-related serious TEAE | 10 (21.3) | 8 (17.0) |
| TEAEs leading to permanent discontinuation of treatment | ||
| TEAE leading to permanent discontinuation of berzosertib | 5 (10.6) | NR |
| Berzosertib-related TEAE leading to permanent discontinuation of berzosertib | 3 (6.4) | NR |
| Cisplatin-related TEAE leading to permanent discontinuation of cisplatin | 8 (17.0) | NR |
| Carboplatin-related TEAE leading to permanent discontinuation of carboplatin | 3 (6.4) | NR |
| TEAE leading to a dose reduction in at least one study drug | 11 (23.4) | NR |
| Berzosertib-related TEAE leading to dose reduction in berzosertib | 3 (6.4) | NR |
| Cisplatin-related TEAE leading to dose reduction in cisplatin | 8 (17.0) | NR |
| Carboplatin-related TEAE leading to dose reduction in carboplatin | 1 (2.1) | NR |
| TEAE leading to temporary discontinuation of at least one study drug | 24 (51.1) | NR |
| Berzosertib-related TEAE leading to temporary discontinuation of berzosertib | 21 (44.7) | NR |
| Cisplatin-related TEAE leading to temporary discontinuation of cisplatin | 15 (31.9) | NR |
| Carboplatin-related TEAE leading to temporary discontinuation of carboplatin | 5 (10.6) | NR |
| TEAE leading to death | 0 | 0 |
NR not reported, TEAE treatment-emergent adverse event.