Table 3.

Most Common Treatment-Related Adverse Events and Hematologic Abnormalities

Adverse Event*	Ixabepilone Plus Capecitabine (n = 595)										Capecitabine (n = 603)
	Grade 1		Grade 2		Grade 3		Grade 4		Any Grade		Grade 1		Grade 2		Grade 3		Grade 4		Any Grade
	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%	No.	%
Nonhematologic abnormality
Peripheral neuropathy	98	17	151	25	140	24	4	0.7	393	66	103	17	14	2.3	7	1.2	0	0	124	21
Peripheral sensory neuropathy†	97	16	154	26	130	22	4	0.7	385	65	101	17	14	2.3	5	0.8	0	0	120	20
Peripheral motor neuropathy	16	3	15	3	22	4	0	0	53	9	6	1	2	0.3	2	0.3	0	0	10	2
Hand-foot syndrome	122	21	136	23	125	21	NA		383	64	123	20	168	28	121	20	NA		412	68
Nausea	156	26	117	20	29	5	0	0	302	51	148	25	61	10	10	2	1	0.2	220	37
Diarrhea	129	22	83	14	41	7	1	0.2	254	43	111	18	66	11	52	9	3	0.5	232	39
Fatigue	94	16	85	14	64	11	5	0.8	248	42	72	12	45	8	17	3	1	0.2	135	22
Vomiting	104	18	93	16	36	6	0	0	233	39	90	15	39	7	12	2	0	0	141	23
Alopecia	69	12	174	29	NA		NA		243	41	11	2	1	0.2	NA		NA		12	2
Nail disorder	98	17	67	11	23	4	0	0	188	32	54	9	16	3	0	0	0	0	70	12
Anorexia	99	17	55	9	6	1	0	0	160	27			18	3	3	0.5	0	0	81	13
Myalgia	49	8	62	10	26	4	1	0.2	138	23	6	1	5	0.8	0	0	0	0	11	2
Stomatitis	62	10	48	8	12	2	0	0	122	21	32	5	31	5	3	0.5	3	0.5	69	11
Constipation	77	13	31	5	1	0.2	1	0.2	110	19	26	4	4	0.7	0	0	1	0.2	31	5
Asthenia	30	5	48	8	37	6	0	0	115	19	23	4	24	4	7	1	1	0.2	55	9
Arthralgia	38	6	37	6	17	3	0	0	92	16	4	0.7	1	0.2	1	0.2	0	0	6	1
Mucositis	47	8	23	4	10	2	0	0	80	13	36	6	11	2	5	0.8	1	0.2	53	9
Hematologic abnormality‡
Leukopenia	59	10	136	23	285	48	87	15	567	96	201	34	98	16	32	5	11	2	342	57
Neutropenia	36	6	76	13	202	34	229	39	543	92	118	20	113	19	33	6	16	3	280	47
Anemia	266	45	230	39	25	4	6	1	527	89	274	46	111	19	19	3	4	0.7	408	68
Thrombocytopenia	261	44	49	8	25	4	12	2	347	59	157	26	15	3	11	2	5	0.8	188	32
Febrile neutropenia	0	0	1	0.2	29	5	12	2	42	7	0	0	0	0	2	0.3	2	0.3	4	0.7

^*By patients' worse Common Terminology Criteria of Adverse Events version 3, except hand-foot syndrome, which was graded using Roche criteria.

^†Included the MedDRA version 9.1 terms of burning sensation, dysesthesia, hyperesthesia, hypoesthesia, neuralgia, neuritis, neuropathy, neuropathy peripheral, neurotoxicity, painful response to normal stimuli, paresthesia, pallanesthesia, peripheral sensory neuropathy, polyneuropathy, and polyneuropathy toxic.

^‡For ixabepilone plus capecitabine, denominators for the individual tests were different: for leukopenia and anemia, n = 591, for neutropenia and thrombocytopenia, n = 590. For capecitabine alone, n = 597.