Table 2.

Toxic Effects of Grade 3 or 4, According to Treatment Group.^*

Toxic Effect	Immunotherapy (N = 137)	Standard Therapy (N = 108)
	number of patients (percent)
Neuropathic pain	71 (52)	6 (6)
Hypotension	24 (18)	0
Hypoxia	18 (13)	2 (2)
Fever without neutropenia	53 (39)	6 (6)
Acute capillary leak syndrome	31 (23)	0
Hypersensitivity reaction	34 (25)	1 (1)
Urticaria	18 (13)	0
Infection (any)	54 (39)	24 (22)
Infection, catheter related	18 (13)	7 (7)
Nausea	4 (3)	1 (1)
Vomiting	8 (6)	3 (3)
Diarrhea	18 (13)	1 (1)
Hyponatremia	31 (23)	4 (4)
Hypokalemia	48 (35)	2 (2)
Abnormal ALT†	31 (23)	3 (3)
Abnormal AST†	14 (10)	0
Hypercalcemia	7 (5)	6 (6)
Serum sickness	1 (1)	0
Ocular symptoms	0	1 (1)
Seizure	1 (1)	1 (1)
CNS cortical symptom‡	5 (4)	0
None	8 (6)	40 (37)

^*Six patients (one in the immunotherapy group and five in the standard-therapy group) could not be evaluated for toxic effects: four withdrew consent before the start of treatment, and two did not report any data. Although a patient may have reported a given toxic effect multiple times, only the worst grade of toxic effect per patient per type is given. Grade 5 toxic effects occurred in one patient only; the patient died from capillary leak syndrome owing to an interleukin-2 overdose. Grade 3 pain refers to pain or severe pain or the use of analgesics severely interfering with the activities of daily living; grade 4 pain refers to disabling pain.

^†Grade 3 elevations of alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels were defined as levels that were 5 to 20 times the upper limit of the normal range, and grade 4 elevations as levels that were more than 20 times the upper limit of the normal range. Toxicities were graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (CTCAE V3).

^‡Central nervous system (CNS) cortical symptoms were encephalopathy, confusion, and psychosis.