Cardiac safety results from a phase II, open-label, multicenter, pilot study of two docetaxel-based regimens plus bevacizumab for the adjuvant treatment of subjects with node-positive or high-risk node-negative breast cancer

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Table 3 Incidence of cardiac adverse events: safety population

	TAC + Bevacizumab (n = 92)		TCH + Bevacizumab (n = 34)		Total (N = 126)
	n^a(%)	95% CI^b	n^a(%)	95% CI^b	n^a(%)	95% CI^b
Subjects with cardiac disorders ^c	24 (26.1)	(17.5–36.3)	6 (17.6)	(6.8–34.5)	30 (23.8)	(16.7–32.2)
Subjects with clinical CHF (≥grade 3) ^d	4 (4.3)	(1.2–10.8)	0	(0.0–10.3)	4 (3.2)	(0.9–7.9)
Cardiac failure congestive	3 (3.3)	(0.7–9.2)	0	(0.0–10.3)	3 (2.4)	(0.5–6.8)
Cardiomyopathy	1 (1.1)	(0.0–5.9)	0	(0.0–10.3)	1 (0.8)	(0.0–4.3)
Left ventricular dysfunction	1 (1.1)	(0.0–5.9)	0	(0.0–10.3)	1 (0.8)	(0.0–4.3)
Subjects with LVEF reduction > 10% or LVEF < lower limit of normal ^e	22 (23.9)	(15.6–33.9)	8 (23.5)	(10.7–41.2)	30 (23.8)	(16.7–32.2)
Cardiac death ^f	0	(0.0–3.9)	0	(0.0–10.3)	0	(0.0–2.9)

Abbreviations:CI = confidence interval; CHF = congestive heart failure; LVEF = left ventricular ejection fraction; TAC = docetaxel, doxorubicin, cyclophosphamide; TCH = docetaxel, carboplatin, trastuzumab.
^aNumber of subjects who had at least one event at any time during the study.
^bExact 2-sided binomial CI.
^cIncludes all subjects with at least one event in the system organ class of Cardiac Disorders.
^dIncludes subjects with at least one ≥ grade 3 event with specified preferred terms.
^eIncludes subjects with LVEF absolute reduction of > 10% from baseline at any time postbaseline, or LVEF < lower limit of normal at any time postbaseline.
^fIncludes subjects with a cardiac disorder event with outcome of death.