Table 3.

Grades 3 to 5 Toxic Effects of Treatment over the Course of All Cycles.^*

Toxic Effect	Interleukin-2 Alone (N = 93)	Vaccine–Interleukin-2 (N = 85)†	P Value
	no. of patients (%)
Hearing	0	1 (1)	0.48
Blood or bone marrow	33 (35)	41 (48)	0.08
Cardiovascular
Arrhythmia	4 (4)	16 (19)	0.002‡
General	25 (27)	31 (36)	0.17
Coagulation	2 (2)	3 (4)	0.67
Constitutional symptoms	15 (16)	24 (28)	0.06
Skin	6 (6)	6 (7)	0.87
Gastrointestinal	17 (18)	18 (21)	0.63
Hemorrhage	1 (1)	2 (2)	0.61
Hepatic	36 (39)	34 (40)	0.86
Infection or febrile neutropenia	6 (6)	7 (8)	0.65
Lymphatic system	0	1 (1)	0.48
Metabolic or laboratory-testing results	19 (21)§	36 (42)	0.002‡
Musculoskeletal	3 (3)	6 (7)	0.31
Neurologic	11 (12)	22 (26)	0.02
Ocular or visual	0	1 (1)	0.48
Pulmonary	19 (21)§	19 (22)	0.81
Pain	10 (11)	11 (13)	0.65
Renal or genitourinary	14 (15)	16 (19)	0.50
Sexual or reproductive function	1 (1)	0	1.00
Syndromes¶	1 (1)	2 (2)	0.61
Maximum reported grade 3–5	74 (80)	73 (86)	0.27

^*Toxic effects were assessed according to the National Cancer Institute Common Toxicity Criteria, version 2.0. P values were calculated with the use of the chi-square test or Fisher’s exact test.

^†A total of 86 patients in this group were treated, but 1 was not assessed for toxic effects.

^‡After Bonferroni adjustment, P values of 0.002 or less were considered to be significant in order to maintain the 0.05 error rate.

^§Data for two patients were missing.

^¶Included are tumor flare, the tumor lysis syndrome, and other syndromes.