Table 2.

Grade 3/4 toxicities by cohort and dose level (number of patients (%)).

Toxicity (CTCAEv4.0 Term)	Total	DL1	DL2	DL3	DL4	DL5	DL6	DL7	DL8	DL9
BRCAmut cohort	70	7	3	3	3	3	4	6	34	7
Any Grade 3/4 toxicity	17 (24)	1 (14)	1 (33)	0	0	0	0	2 (33)	11 (32)	2 (29)
Grade 3 toxicity
Any Grade 3 toxicity	15 (21)	1 (14)	0	0	0	0	0	2 (33)	11 (32)	1 (14)
Lymphocyte count decreased	9 (13)	0	0	0	0	0	0	1 (17)	7 (21)	1 (14)
Thromboembolic event	2 (3)	0	0	0	0	0	0	0	2 (6)	0
Nausea	2 (3)	0	0	0	0	0	0	0	2 (6)	0
Abdominal pain	2 (3)	0	0	0	0	0	0	0	2 (6)	0
Anemia	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Alkaline phosphatase increased	1 (1)	1 (14)	0	0	0	0	0	0	0	0
Aspartate aminotransferase increased	1 (1)	1 (14)	0	0	0	0	0	0	0	0
Appendicitis	1 (1)	0	0	0	0	0	0	1 (17)	0	0
Headache	1 (1)	0	0	0	0	0	0	1 (17)	0	0
Dehydration	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Urinary tract infection	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Fatigue	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Hypophosphatemia	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Grade 4 toxicity
Any Grade 4 toxicity	3 (4)	0	1 (33)	0	0	0	0	0	1 (3)	1 (14)
Lymphocyte count decreased	1 (1)	0	0	0	0	0	0	0	1 (3)	0
Thromboembolic event	1 (1)	0	1 (33)	0	0	0	0	0	0	0
Anemia	1 (1)	0	0	0	0	0	0	0	0	1 (14)
Dyspnea	1 (1)	0	0	0	0	0	0	0	0	1 (14)
Platelet count decreased	1 (1)	0	0	0	0	0	0	0	0	1 (14)
BRCAwt cohort	28	3	3	3	3	3	3	3	7	0
Grade 3 toxicity
Any Grade 3 toxicity	8 (29)	0	1 (33)	0	2 (67)	0	2 (67)	0	3 (43)	-
Lymphocyte count decreased	5 (18)	0	1 (33)	0	2 (67)	0	1 (33)	0	1 (14)	-
Basilic vein thrombosis	1 (4)	0	0	0	0	0	1 (33)	0	0	-
Dyspnea	1 (4)	0	0	0	0	0	0	0	1 (14)	-
Fatigue	1 (4)	0	0	0	0	0	0	0	1 (14)	-
Hypophosphatemia	1 (4)	0	0	0	0	0	0	0	1 (14)	-

At dose levels 3 and 5, no grade 3/4 toxicities were observed.