Table 4.

Adverse Events of Interest and Serious Adverse Events

	Placebo (N=51)		SPL 12.5 mg (N=27)		SPL 25 mg (N=26)		SPL 50 mg (N=25)		p-Values for Event Rates
	Pts w/event No. (%)	Events per pt-year	Pts w/event No. (%)	Events per pt-year	Pts w/event No. (%)	Events per pt-year	Pts w/event No. (%)	Events per pt-year	Trend	Combined SPL vs Placebo
Breast enlargement or tenderness	2 (3.9)	0.05	0 (0.0)	0.00	1 (3.8)	0.06	2 (8.0)	0.11	0.7	0.9
Rash	2 (3.9)	0.05	1 (3.7)	0.05	1 (3.8)	0.06	2 (8.0)	0.11	0.3	<0.001
Nausea	6 (11.8)	0.16	8 (29.6)	0.48	4 (15.4)	0.23	1 (4.0)	0.05	0.2	0.01
Vomiting	5 (9.8)	0.13	7 (25.9)	0.42	2 (7.7)	0.40	1 (4.0)	0.11	0.8	0.1
Diarrhea	5 (9.8)	0.24	4 (14.8)	0.21	5 (19.2)	0.40	3 (12.0)	0.21	0.7	0.8
Anorexia	0 (0.0)	0.00	0 (0.0)	0.00	1 (3.8)	0.06	0 (0.0)	0.00	0.2	0.9
Constipation	2 (3.9)	0.05	1 (3.7)	0.05	1 (3.8)	0.28	0 (0.0)	0.00	0.03	<0.001
Any gastrointestinal symptoms	11 (21.6)	0.45	11 (40.7)	0.79	8 (30.8)	1.14	4 (16.0)	0.32	0.6	0.1
Serious adverse eventa	27 (52.9)	1.79	13 (48.1)	1.43	13 (50.0)	2.68	12 (48.0)	2.26	0.2	0.5

^aSerious adverse events include any adverse event that: is fatal or result in death, is life-threatening, requires or prolongs hospitalization, results in persistent or significant disability or incapacity, results in congenital anomalies or birth defects or is considered an important medical event Abbreviation: SPL, spironolactone; pt, patient