Treatment-emergent adverse events
| Patients with event . | Combination therapy, N = 55 . | BV monotherapy, N = 31 . |
|---|---|---|
| n (%) . | ||
| Any TEAE | 54 (98.2) | 28 (90.3) |
| Grade 3/4 TEAEs | 26 (47.3) | 8 (25.8) |
| SAEs | 13 (23.6) | 3 (9.7) |
| TEAEs leading to treatment discontinuation | 13 (23.6) | 8 (25.8) |
| TEAEs leading to dose modification | 14 (25.5) | 14 (45.2) |
| Dose delay | 7 (12.7) | 9 (29.0) |
| Dose reduction | 3 (5.5) | 8 (25.8) |
| Infusion interruption or early termination | 6 (10.9) | 1 (3.2) |
| Infusion-related reactions | 31 (56.4) | 7 (12.7) |
| Peripheral neuropathy | 13 (23.6) | 21 (67.7) |
| Febrile neutropenia* | 0 (0.0) | 1 (3.2) |
| Patients with event . | Combination therapy, N = 55 . | BV monotherapy, N = 31 . |
|---|---|---|
| n (%) . | ||
| Any TEAE | 54 (98.2) | 28 (90.3) |
| Grade 3/4 TEAEs | 26 (47.3) | 8 (25.8) |
| SAEs | 13 (23.6) | 3 (9.7) |
| TEAEs leading to treatment discontinuation | 13 (23.6) | 8 (25.8) |
| TEAEs leading to dose modification | 14 (25.5) | 14 (45.2) |
| Dose delay | 7 (12.7) | 9 (29.0) |
| Dose reduction | 3 (5.5) | 8 (25.8) |
| Infusion interruption or early termination | 6 (10.9) | 1 (3.2) |
| Infusion-related reactions | 31 (56.4) | 7 (12.7) |
| Peripheral neuropathy | 13 (23.6) | 21 (67.7) |
| Febrile neutropenia* | 0 (0.0) | 1 (3.2) |
SAE, serious adverse event; TEAE, treatment-emergent adverse event.
A total of 18 patients received prophylactic growth factor support during the study, 9 of whom received primary prophylaxis.