Table 3.

SAEs of venetoclax and LDAC

SAEs (SOC/PT)	Patients, N = 14, n (%)
Any SAEs	6 (42.9%)
Blood and lymphatic system disorders	3 (21.4%)
Febrile neutropenia	3 (21.4%)
Cardiac disorder/cardiac failure	1 (7.1%)
Infections and infestations	2 (14.3%)
Gastroenteritis	1 (7.1%)
Nasopharyngitis	1 (7.1%)
Neoplasms: benign, malignant and unspecified/AMLa	1 (7.1%)
Renal and urinary disorders/AKI	1 (7.1%)

No patients reported tumor lysis syndrome (TLS) in this study, where all patients received either TLS-prophylactic agents or hydration. SAE, serious adverse event; SOC/PT, MedDRA system organ class and preferred term; AKI, acute kidney injury.

^aMedDRA PT for ‘aggravation of AML,’ which was defined as an investigator-reported AE.