Table 3.
Patients with an SAE, n (%) N = 26 | All AEs | Study drug–related AEs |
---|---|---|
Febrile neutropenia | 13 (50.0) | 2 (7.7) |
Lung infection | 3 (11.5) | 0 |
Aspergillus infection | 1 (3.8) | 0 |
Bacterial sepsis | 1 (3.8) | 0 |
Cellulitis | 1 (3.8) | 0 |
Enterobacter bacteremia | 1 (3.8) | 0 |
Enterobacter infection | 1 (3.8) | 0 |
Enterococcal sepsis | 1 (3.8) | 0 |
Proctitis herpes | 1 (3.8) | 0 |
Pseudomonal bacteremia | 1 (3.8) | 0 |
Sepsis | 1 (3.8) | 0 |
Colitis | 1 (3.8) | 1 (3.8) |
Gastritis | 1 (3.8) | 1 (3.8) |
Acute coronary syndrome | 1 (3.8) | 0 |
Acute cardiac failure | 1 (3.8) | 0 |
Myocardial ischemia | 1 (3.8) | 0 |
Blood creatinine increased | 1 (3.8) | 1 (3.8) |
Electrocardiogram QT interval prolonged | 1 (3.8) | 1 (3.8) |
Dyspnea | 1 (3.8) | 0 |
Pyrexia | 1 (3.8) | 0 |
Menorrhagia | 1 (3.8) | 0 |
Thrombosis | 1 (3.8) | 0 |
AE adverse event, MedDRA Medical Dictionary for Regulatory Activities, SAE serious adverse event