Table 4. Adverse clinical effects associated with RCC vaccine.

Episodes of toxicity. Toxicities, where applicable, are graded by National Cancer Institute Common Toxicity Criteria.

	Dose level 1		Dose level 2		Dose level 3
	−GM-CSF gene	+GM-CSF gene	−GM-CSF gene	+GM-CSF gene	−GM-CSF gene
No. of fully evaluable patients	3	4	4	3	2
No. of fully evaluable cycles	7	8	13	7	4
Systemic side effects
Fever					1a
Nausea/vomiting					1b
Constipation				3c
Pruritus (non-vaccine site)			2	2
Urticaria without bronchospasm				2d
Myalgia			2
Other deep vein thrombosis				1e
Clinical evidence of autoimmune disease
Renal function change: creatinine/proteinuria
Thyroid
Rheumatoid arthritis
Lupus
Acute vaccine site effects
Injection site erythema ID/SQ	7/0	6/0	13/3	7/4	4/4
Site tenderness/swelling			6ae	7e	2e
Pruritus			2	3f	1

^aGrade 2.

^bGrade 1.

^cGrade 2, 2 episodes; Grade 1, 1 episode; same patient.

^d1 episode at DTH site, 1 episode at vaccine site; same patient.

^eOccurred on nonvaccinated limb in a patient on bed rest for non-cancer-related back injury.

^fIntermittent pruritus in patient 24.