Table 1.

Part B: patients with study drug-related treatment-emergent AEs, overall and by system organ class and preferred term (including only preferred terms reported by one or more patient with Grade 3 events) (safety population).

System organ class preferred term	Grade 3		Any grade
	N	%	N	%
Patients with any drug-related AE	10	28.6	33	94.3
Blood and lymphatic system disorders	3	8.6	18	51.4
Anemia	2	5.7	6	17.1
Neutropenia	1	2.9	2	5.7
Thrombocytopenia	1	2.9	16	45.7
Cardiac disorders	0a	0	1	2.9
Gastrointestinal disorders	4	11.4	26	74.3
Diarrhea	4	11.4	18	51.4
General disorders and administration site conditions	2	5.7	9	25.7
Asthenia	2	5.7	8	22.9
Investigations	0a	0	19	54.3
Metabolism and nutrition disorders	1	2.9	8	22.9
Hypocalcemia	1	2.9	4	11.4
Nervous system disorders	0a	0	5	14.3
Renal and urinary disorders	0a	0	2	5.7
Respiratory, thoracic and mediastinal disorders	0a	0	1	2.9
Skin and subcutaneous tissue disorders	1	2.9	6	17.1
Rash	1	2.9	1	2.9

Data are from 35 patients. Grades are based on the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.03, where Grade 1 are mild events, Grade 2 are moderate, Grade 3 are severe, Grade 4 are life-threatening, and Grade 5 events result in death. There were no Grade 4 or 5 events in Part B of the study.

AE adverse event.

^aThere were no Grade 3 events for these system organ classes.