Table 3.

Most frequent (in ≥5% of patients) TRAEs and treatment-related SAEs in Part 1A

	Grade 1	Grade 2	Grade 3	Grade 4	Grade 5	Total
By preferred term
Most frequent TRAEs (≥5% of patients)
With any adverse event (worst grade)	10 (23.8)	8 (19.0)	12 (28.6)	0	0	30 (71.4)
Alanine aminotransferase increased	4 (9.5)	2 (4.8)	4 (9.5)	0	0	10 (23.8)
Aspartate aminotransferase increased	6 (14.3)	4 (9.5)	0	0	0	10 (23.8)
Anemia	0	4 (9.5)	4 (9.5)	0	0	8 (19.0)
Nausea	4 (9.5)	3 (7.1)	0	0	0	7 (16.7)
Headache	5 (11.9)	1 (2.4)	0	0	0	6 (14.3)
Blood alkaline phosphatase increased	4 (9.5)	0	0	0	0	4 (9.5)
Decreased appetite	3 (7.1)	1 (2.4)	0	0	0	4 (9.5)
Fatigue	3 (7.1)	0	1 (2.4)	0	0	4 (9.5)
Vomiting	4 (9.5)	0	0	0	0	4 (9.5)
Diarrhea	3 (7.1)	0	0	0	0	3 (7.1)
Myalgia	2 (4.8)	1 (2.4)	0	0	0	3 (7.1)
Rash	3 (7.1)	0	0	0	0	3 (7.1)
Treatment-related SAEs
With any adverse event (worst grade)	0	0	4 (9.5)	0	0	4 (9.5)
Anemia	0	0	2 (4.8)	0	0	2 (4.8)
Hepatic hemorrhage	0	0	1 (2.4)	0	0	1 (2.4)
Hypotension	0	0	1 (2.4)	0	0	1 (2.4)
Intracranial tumor hemorrhage	0	0	1 (2.4)	0	0	1 (2.4)
Pyrexia	0	1 (2.4)	0	0	0	1 (2.4)

Values are presented as n (%) of patients.

SAE, serious adverse event; TRAE, treatment-related adverse event.