Table 1.

Adverse events in sipuleucel-T studies that occurred at least twice as often in the sipuleucel-T arm in at least one study

Side effect	Study	Percentage in sipuleucel-T group (grade ≥3)	Percentage in control group (grade ≥3)
Chills	IMPACT	54.1 (1.2)	12.5 (0)
	D9901/D9902A	57.8 (4.8)	7.9 (0)
	PROTECT	44.0 (1.7)	10.2 (0)
Pyrexia	IMPACT	29.3 (0.3)	13.7 (1.8)
	D9901/D9902A	32.0 (2.0)	6.6 (0)
	PROTECT	36.2 (1.7)	1.7 (0)
Headache	IMPACT	16.0 (0.3)	4.8 (0)
	D9901/D9902A	19.0 (1.4)	6.6 (0)
	PROTECT	23.3 (0.9)	13.6 (0)
Myalgia	IMPACT	9.8 (0.6)	4.8 (0)
	D9901/D9902A	NR	NR
	PROTECT	21.6 (0.9)	8.5 (0)
Influenza-like illness	IMPACT	9.8 (0)	3.6 (0)
	D9901/D9902A	NR	NR
	PROTECT	13.8 (0)	3.4 (0)
Hypertension	IMPACT	7.4 (0.6)	3.0 (0)
	D9901/D9902A	NR	NR
	PROTECT	11.2 (0)	13.6 (0)
Adverse events reported in only one study
Pain	PROTECT	12.9 (0)	0 (0)
Groin pain	IMPACT	5.0 (0)	2.4 (0)
Vomiting	D9901/D9902A	10.9 (0.7)	2.6 (0)
Dyspnea	D9901/D9902A	10.9 (3.4)	2.6 (1.3)
Asthenia	D9901/D9902A	14.3 (0)	3.9 (0)
Hyperhidrosis	IMPACT	5.3 (0)	0.6 (0)

Note: D9901 and D9902A population data are pooled.

Abbreviations: IMPACT, Immunotherapy for Prostate Adenocarcinoma Treatment; PROTECT, Provenge Treatment and Early Cancer Treatment; NR, not reported.