AEs
| . | VMP (n = 53) . | S+VMP (n = 52) . |
|---|---|---|
| Any AE grade ≥3 | 81% | 92% |
| Most common AEs grade ≥3 | ||
| Neutropenia | 43% | 62% |
| Thrombocytopenia | 25% | 44% |
| Bronchopneumonia/pneumonia | 17% | 17% |
| Anemia | 13% | 13% |
| Hypokalemia | 2% | 11.5% |
| Diarrhea | 9% | 4% |
| Peripheral sensory neuropathy | 9% | 6% |
| SAEs | 51% | 58% |
| Most frequently reported SAEs | ||
| Infections | 17% | 23% |
| Gastrointestinal disorders | 11% | 11.5% |
| Death due to an AE | 4 (7%)* | 5 (10%)* |
| . | VMP (n = 53) . | S+VMP (n = 52) . |
|---|---|---|
| Any AE grade ≥3 | 81% | 92% |
| Most common AEs grade ≥3 | ||
| Neutropenia | 43% | 62% |
| Thrombocytopenia | 25% | 44% |
| Bronchopneumonia/pneumonia | 17% | 17% |
| Anemia | 13% | 13% |
| Hypokalemia | 2% | 11.5% |
| Diarrhea | 9% | 4% |
| Peripheral sensory neuropathy | 9% | 6% |
| SAEs | 51% | 58% |
| Most frequently reported SAEs | ||
| Infections | 17% | 23% |
| Gastrointestinal disorders | 11% | 11.5% |
| Death due to an AE | 4 (7%)* | 5 (10%)* |
Death was considered drug related in 1 patient in the VMP arm. Causes of death in the VMP arm were pneumonia/bronchopneumonia (n = 3) and cardiorespiratory arrest (n = 1). Causes of death in the S+VMP arm were pneumonia/bronchopneumonia (n = 3), respiratory failure (n = 1), and suicide (n = 1).