Table 3.

Treatment-Related Adverse Events

Adverse Event	Grade										P
	CIS Plus RT (n = 187)					CIS, TPZ, and RT (n = 179)
	0	1	2	3	4	0	1	2	3	4
Leukopenia	48	30	60	43	6	53	26	47	47	6
Anemia	37	60	75	16	0	46	58	65	10	0
Thrombocytopenia	115	57	8	5	2	113	52	8	3	3
ANC	103	25	31	20	8	101	22	30	23	3
Other hematologic	163	2	3	11	8	160	2	1	9	7
Allergy/immunology	182	4	1	0	0	171	4	2	2	0
Auditory/ear	161	2	11	0	0	68	0	19	0	1
Cardiac	179	5	2	1	0	152	1	25	0	0
Fatigue	49	66	58	14	0	49	61	46	20	3
Fever, without neutropenia	176	8	3	0	0	171	3	5	0	0
Other constitutional symptoms	139	38	10	0	0	120	39	18	2	0
Dermatologic*	137	36	14	0	0	102	35	26	15	1	< .001
Endocrine	174	8	4	1	0	175	3	1	0	0
Nausea	60	77	37	13	0	46	63	58	12	0
Vomiting*	113	41	21	12	0	74	44	49	12	0	< .001
Diarrhea*	72	81	23	11	0	70	52	38	19	0	.007
Constipation	149	29	9	0	0	143	23	11	1	1
Other GI	108	43	28	8	0	91	38	41	8	1
Renal/genitourinary	135	30	20	2	0	142	26	9	2	0
Hemorrhage/bleeding	169	16	1	1	0	165	10	2	2	0
Hepatobiliary/pancreas	187	0	0	0	0	178	0	0	1	0
Infection	166	0	9	11	1	153	0	17	8	1
Lymphatics	181	6	0	0	0	164	10	4	1	0
Metabolic/laboratory	92	45	25	19	6	76	47	19	33	4
Musculoskeletal/soft tissue	176	7	4	0	0	159	8	7	5	0
Neuropathy, motor*	186	0	1	0	0	168	6	5	0	0	.003
Neuropathy, sensory	159	24	3	1	0	152	20	6	1	0
Other neurologic	157	20	8	1	1	137	25	9	8	0
Ocular/visual	179	8	0	0	0	163	15	1	0	0
Pain*	118	42	24	3	0	76	36	38	29	0	< .001
Pulmonary	174	10	1	2	0	164	8	3	4	0
Sexual/reproductive	168	18	1	0	0	166	9	4	0	0
Vascular	182	2	0	3	0	175	0	1	2	1

NOTE. There was one treatment-related death.

Abbreviations: ANC, absolute neutrophil count; CIS, cisplatin; RT, radiotherapy; TPZ, tirapazamine.

^*Distribution of toxicity grade significantly different across treatment arms (Fisher's exact test).