Table 1.

Drug-related adverse events occurring in ≥ 5% of evaluable patients at grade III or greater

Drug-related adverse events categorized by SOC and PT	Number of patients with grade I/II at > 5% incidence	Number of patients with ≥ grade III
Hematological
Neutropenia	17 (68.0)	11 (44.0)
Leukopenia	11 (44.0)	2 (8.0)
Thrombocytopenia	5 (20.0)	1 (4.0)
Lymphocythemia	3 (12.0)	2 (8.0)
Anemia	3 (12.0)	0
Leukocytosis	2 (8.0)	0
Non-hematological
Elevated serum lactate dehydrogenase	11 (44.0)	1 (4.0)
Elevated serum α-hydroxybutyrate dehydrogenase	6 (24.0)	1 (4.0)
Hyperuricemia	5 (20.0)	3 (12.0)
Upper respiratory tract infection	4 (16.0)	1 (4.0)
Pneumonia	4 (16.0)	4 (16.0)
Proteinuria	4 (16.0)	0
Hyperbilirubinemia	3 (12.0)	0
Elevated alanine aminotransferase	3 (12.0)	0
Elevated aspartate aminotransferase	2 (8.0)	0
Elevated serum alkaline phosphatase	3 (12.0)	0
Weight loss	3 (12.0)	0
Pneumonitis	3 (12.0)	2 (8.0)
Weight gain	2 (8.0)	1 (4.0)
Elevated γ-glutamyltransferase	2 (8.0)	0
Elevated bilirubin	2 (8.0)	0
Diarrhea	2 (8.0)	0
Cough	2 (8.0)	0
Oropharyngeal pain	2 (8.0)	0
Maculopapule	2 (8.0)	0
Fever	2 (8.0)	0
Fatigue	2 (8.0)	0

AE adverse event, SOC system organ class, PT preferred term