Table 6.

Proportions of participants who experienced each category of adverse event by dose level ^*

Adverse Event	Saw palmetto (%)	Placebo (%)	p-value for drug	p-value (Double vs Single)**	p-value (Triple vs single)**
Arrhythmia			0.67	0.41	0.41
Single dose	2.3	2.2
Double dose	1.1	1.7
Triple dose	1.1	1.7
Elevated blood pressure			0.10	0.20	0.12
Single dose	4.0	1.7
Double dose	2.8	0
Triple dose	0.6	1.7
Upper respiratory infection			0.64	0.17	<0.001
Single dose	11.8	15.9
Double dose	10.6	10.2
Triple dose	6.3	6.0
Flu-like symptoms			0.60	0.28	0.45
Single dose	4.5	3.3
Double dose	3.4	1.7
Triple dose	2.3	3.3
Oral/dental			0.10	0.72	<0.001
Single dose	5.7	5.0
Double dose	6.8	2.8
Triple dose	1.7	0
Musculoskeletal			0.44	0.28	0.41
Single dose	15.6	15.5
Double dose	15.6	9.9
Triple dose	13.4	13.0
Genitourinary			0.90	0.98	0.78
Single dose	10.6	8.7
Double dose	9.5	9.7
Triple dose	8.4	9.3
Elevated PSA			0.81	0.65	0.35
Single dose	1.1	2.8
Double dose	2.8	2.2
Triple dose	4.0	2.2
Gastrointestinal			0.69	0.72	0.09
Single dose	12.4	10.9
Double dose	10.1	11.3
Triple dose	6.2	9.3
Dermatologic			0.30	0.73	0.56
Single dose	2.8	4.9
Double dose	3.9	2.7
Triple dose	2.8	6.6
Physical injury/trauma			0.02	0.37	0.18
Single dose	4.0	1.1
Double dose	5.1	2.2
Triple dose	6.2	2.8
Abnormal serum chemistry			0.66	0.69	0.07
Single dose	0	1.7
Double dose	0.6	0.6
Triple dose	4.5	1.7

^*Includes only those adverse events that occurred in at least 5% of study participants

^**p-value for comparing dose levels across treatments and time adjusting for intra-patient variation using generalized estimating equations