Table 3.

Summary of serious adverse events (per MedDRA preferred term)

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