Table 4 Final combined AE multivariate models of associations between adverse events and survival end points for mRCC patients receiving sunitinib on (A) Schedule 4/2 or (B) any dose/schedule

		Adverse event at any time point			Adverse event by the 12-week landmark
Adverse event	End point	HR	95% CI	P-value^a	HR	95% CI	P-value^a
(A) Schedule 4/2
Neutropenia	PFS	0.77	0.61–0.97	0.0276	0.72	0.56–0.93	0.0130
	OS	0.65	0.50–0.85	0.0014	0.71	0.55–0.93	0.0122
Hypertension	PFS	0.37	0.27–0.52	<0.0001	0.81	0.61–1.07	0.1305
	OS	0.36	0.27–0.50	<0.0001	0.68	0.53–0.88	0.0036
Hand–foot syndrome	PFS	0.90	0.70–1.15	0.3986	0.83	0.59–1.16	0.2651
	OS	0.70	0.52–0.93	0.0152	0.64	0.44–0.94	0.0218
Asthenia/fatigue	PFS	0.56	0.42–0.74	<0.0001	1.01	0.78–1.30	0.9555
	OS	0.82	0.61–1.10	0.1882	0.99	0.78–1.27	0.9586
Thrombocytopenia	PFS	0.83	0.63–1.10	0.1971	1.05	0.73–1.51	0.7905
	OS	0.96	0.70–1.33	0.8271	1.07	0.74–1.53	0.7233
(B) Any dose/schedule
Neutropenia	PFS	0.69	0.56–0.85	0.0004	0.72	0.57–0.91	0.0062
	OS	0.58	0.45–0.73	<0.0001	0.68	0.53–0.87	0.0019
Hypertension	PFS	0.44	0.33–0.58	<0.0001	0.98	0.76–1.26	0.8730
	OS	0.48	0.37–0.63	<0.0001	0.73	0.58–0.91	0.0063
Hand–foot syndrome	PFS	0.88	0.70–1.10	0.2495	0.88	0.64–1.19	0.3963
	OS	0.69	0.52–0.90	0.0062	0.60	0.42–0.86	0.0049
Asthenia/fatigue	PFS	0.69	0.54–0.88	0.0026	0.98	0.79–1.23	0.8786
	OS	0.94	0.73–1.22	0.6576	0.96	0.77–1.19	0.7056
Thrombocytopenia	PFS	0.96	0.75–1.24	0.7557	1.09	0.79–1.51	0.5920
	OS	1.00	0.76–1.32	0.9863	1.11	0.81–1.52	0.5096

Abbreviations: AE=adverse event; CI=confidence interval; HR=hazard ratio; mRCC=metastatic renal cell carcinoma; OS=overall survival; PFS=progression-free survival.
Statistically significant results are in bold font.
^aTwo-sided Wald chi-squared test.

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