Table 3.

Sequential LVEF assessments^a

	Arm A	Arm B
Median baseline LVEF (%)	65 (50–82)	63 (53–78)
Cycle 5	N = 94	N = 113
Median LVEF (%)	63 (36–87)	61 (45–80)
LVEF decrease >10%, n (%)	13 (14)	7 (6)
LVEF decrease >15% or >10% to <LLN, n (%)	7 (7)	4 (4)
Cycle 9	N = 82	N = 94
Median LVEF	62 (42–81)	60.5 (46–77)
LVEF decrease >10%, n (%)	10 (12)	10 (11)
LVEF decrease >15% or >10% to <LLN, n (%)	4 (5)	3 (3)
Cycle 17	N = 61	N = 82
Median LVEF (%)	61 (35–79)	59 (45–80)
LVEF decrease >10%, n (%)	14 (23)	13 (16)
LVEF decrease >15% or >10% to <LLN, n (%)b	9 (15)	4 (5)
Cycle 24/25	N = 56	N = 69
Median LVEF (%)	58.5 (30–78)	60 (39–78)
LVEF decrease >10%, n (%)	7 (13)	12 (17)
LVEF decrease >15% or >10% to <LLN, n (%)	2 (4)	2 (3)
End of treatment	N = 72	N = 86
Median LVEF (%)	60 (34–73)	60 (41–80)
LVEF decrease >10%, n (%)	14 (19)	18 (21)
LVEF decrease >15% or >10% to <LLN, n (%)	11 (15)	10 (12)
Post treatment 1	N = 53	N = 56
Median LVEF (%)	60 (25–78)	59.5 (38–73)
LVEF decrease >10%, n (%)	6 (11)	8 (14)
LVEF decrease >15% or >10% to <LLN, n (%)	4 (8)	4 (7)
Post treatment 2	N = 26	N = 34
Median LVEF (%)	66 (37–85)	59.5 (45–76)
LVEF decrease >10%, n (%)	4 (15)	5 (15)
LVEF decrease >15% or >10% to <LLN, n (%)	1(4)	2 (6)

CHF, cardiac dysfunction; LLN, lower limit of normal; LVEF, left ventricular ejection fraction.

^aLVEF listed for each time point was compared with baseline LVEF irrespective of LVEF at any prior time point. Reasons for missing LVEF assessments over time include treatment discontinuation, site error, patient noncompliance or refusal, and disease progression.

^bThere is a significant difference between groups at this time point. Of the 13 patients with LVEF decrease >15% or >10% to <LLN at this time point, 1 developed clinical CHF and 12 reported a subsequent LVEF within the normal range.