Table 2.

Grade 3/4 toxicities by dose level.

Schedule	28 days	28 days	28 days	21 days	21 days	21 days	21 days
Veliparib (mg BID)/ gemcitabine (mg/m2)	10 / 750 (n=3)	10 / 500 (n=8)	Total (n=11)	20 / 500 (n=3)	20 / 750 (n=14)	40 / 750 (n=3)	Total (n=20)
Grade 3/4 Toxicities	Number of Patients (percent)
Any toxicities	3 (100%)	5 (63%)	8 (73%)	3 (100%)	10 (71%)	2 (67%)	15 (75%)
Grade 3 hematologic	3 (100%)	4 (50%)	7 (64%)	2 (67%)	8 (57%)	2 (67%)	12 (60%)
Anemia	0	2 (25%)	2 (18%)	1 (33%)	2 (14%)	0	3 (15%)
Lymphocyte count decreased	0	1 (13%)	1 (9%)	1 (33%)	1 (7%)	0	2 (10%)
White blood cell decreased	2 (67%)	1 (13%)	3 (27%)	0	4 (29%)	0	4 (20%)
Neutrophil count decreased	1 (33%)	2 (25%)	3 (27%)	1 (33%)	5 (36%)	2 (67%)	8 (40%)
Platelet count decreased	2 (67%)	1 (13%)	3 (27%)	0	1 (7%)	0	1 (5%)
Grade 4 hematologic	0	0	0	2 (67%)	2 (14%)	0	4 (20%)
Lymphocyte count decreased	0	0	0	1 (33%)	1 (7%)	0	2 (10%)
Neutrophil count decreased	0	0	0	1 (33%)	1 (7%)	0	2 (10%)
Grade 3 non-hematologic	2 (67%)	2 (25%)	4 (36%)	2 (67%)	3 (21%)	0	5 (25%)
Abdominal pain	0	0	0	0	1 (7%)	0	1 (5%)
Alanine aminotransferase increased	0	0	0	0	1 (7%)	0	1 (5%)
Aspartate aminotransferase increase	0	0	0	1 (33%)	1 (7%)	0	2 (10%)
Fatigue	1 (33%)	0	1 (9%)	0	0	0	0
Diverticulitis	0	0	0	0	1 (7%)	0	1 (5%)
Hypokalemia	0	0	0	1 (33%)	0	0	1 (5%)
Hyponatremia	1 (33%)	0	1 (9%)	0	0	0	0
Ileus	0	0	0	1 (33%)	0	0	1 (5%)
Nausea	1 (33%)	1 (13%)	2 (18%)	1 (33%)	0	0	1 (5%)
Vomiting	0	1 (13%)	1 (9%)	1 (33%)	0	0	1 (5%)

Veliparib dose in mg BID; gemcitabine dose in mg/m².

Number of patients experiencing adverse event (percentage). Only adverse event possibly, probably, or definitely related to treatment were listed.