Table 3.

Treatment-related adverse events (AEs) occurring in ≥10% of patients in any one treatment arm.

AE, n (%)	Arm A (n = 41)		Arm B (n = 25)		Arm C (n = 24)
	BI 860585		BI 860585 + Exemestane		BI 860585 + Paclitaxel
	All Grade	Grade ≥ 3	All Grade	Grade ≥ 3	All Grade	Grade ≥ 3
Any treatment-related AEs	36 (88)	11 (27)	24 (96)	9 (36)	24 (100)	12 (50)
Hyperglycemia	22 (54)	1 (2)	9 (36)	1 (4)	13 (54)	0
Diarrhea	16 (39)	2 (5)	10 (40)	2 (8)	14 (58)	4 (17)
Nausea	15 (37)	0	5 (20)	0	9 (37)	0
Rash	11 (27)	3 (7)	8 (32)	4 (16)	7 (29)	1 (4)
Fatigue	10 (24)	0	9 (36)	2 (8)	14 (58)	2 (8)
Decreased appetite	9 (22)	0	7 (28)	0	11 (46)	0
Stomatitis	9 (22)	0	10 (40)	2 (8)	7 (29)	0
Vomiting	9 (22)	0	3 (12)	0	4 (17)	0
Hypertriglyceridemia	8 (20)	0	0	0	2 (8)	0
Hypercholesterolemia	6 (15)	0	4 (16)	0	6 (25)	0
Creatine phosphokinase increased	6 (15)	0	6 (24)	0	3 (13)	1 (4)
Asthenia	4 (10)	0	3 (12)	0	3 (13)	0
Lipase increased	4 (10)	1 (2)	3 (12)	0	1 (4)	0
Pruritus	3 (7)	1 (2)	5 (20)	0	5 (21)	0
AST increased	3 (7)	2 (5) †	4 (16)	0	2 (8)	0
ALT increased	2 (5)	2 (5) †	3 (12)	0	2 (8)	0
Polyneuropathy	2 (5)	0	0	0	7 (30)	2 (8)
Anemia	1 (2)	0	1 (4)	0	12 (50)	2 (8)
Dry mouth	1 (2)	0	4 (16)	0	3 (13)	0
Dry skin	1 (2)	0	0	0	5 (21)	0
Abdominal pain	1 (2)	0	1 (4)	1 (4)	4 (17)	0
Weight decreased	1 (2)	0	1 (4)	0	5 (21)	0
Hypomagnesemia	1 (2)	0	0	0	4 (17)	1 (4)
Neutropenia	0	0	0	0	7 (29)	1 (4) †
White blood cell count decreased	0	0	1 (4)	0	6 (25)	4 (17)
Alopecia	0	0	0	0	5 (21)	0
Paresthesia	1 (2)	0	0	0	3 (13)	0
Epistaxis	0	0	0	0	4 (17)	0
Paronychia	0	0	0	0	3 (13)	0

Abbreviations: AEs: Adverse events; ALT: Alanine aminotransferase; AST: Aspartate aminotransferase. ^† One grade 4 event.