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. 2020 Feb 4;38(5):1430–1441. doi: 10.1007/s10637-020-00907-4

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