Table 3.

Adverse events occurring in 5% or more of subjects in either treatment group (safety population)

	No. Vehicle (%)*	No. PRX302 (%)*	p Value (Fisher’s exact test)
Hematuria	11 (35.5)	18 (29.5)	0.64
Dysuria	2 (6.5)	17 (27.9)	0.027
Pollakiuria	5 (16.1)	14 (23.0)	0.59
Micturition urgency	3 (9.7)	13 (21.3)	0.25
Perineal pain	0 (0.0)	7 (11.5)	0.091
Vertigo	2 (6.5)	4 (6.6)	1.00
Malaise	0 (0.0)	4 (6.6)	0.30
Insomnia	3 (9.7)	2 (3.3)	0.33
Arthralgia	2 (6.5)	2 (3.3)	0.60
Hematospermia	2 (6.5)	2 (3.3)	0.60
Nocturia	2 (6.5)	2 (3.3)	0.60
Prostatic pain	3 (9.7)	1 (1.6)	0.11
Headache	2 (6.5)	1 (1.6)	0.26
Urinary retention	3 (9.7)	0 (0.0)	0.036
Anxiety	2 (6.5)	0 (0.0)	0.11
Diarrhea	2 (6.5)	0 (0.0)	0.11

MedDRA (Medical Dictionary for Regulatory Activities) coded preferred terms.

^*Number of patients with 1 or more events of that nature.