Table 5. Adverse Events, side effects by Sex.

	Sex
Side effects, adverse events	Male N=1043(36.3%)		Women N=1833(63.7%)		Total N=2876		p-value
	n	%	n	%	n	%
Maximum SE Frequency							0.1770
None	153	14.7	295	16.2	448	15.7
10%-25% of the time	276	26.5	532	29.2	808	28.2
50%-75% of the time	343	33.0	571	31.4	914	32.0
90%-100% of the time	268	25.8	423	23.2	691	24.1
Maximum SE Intensity							0.1184
None	151	14.5	291	16.0	442	15.5
Trivial	273	26.3	520	28.6	793	27.7
Moderate	432	41.5	741	40.7	1173	41.0
Severe	184	17.7	269	14.7	453	15.8
Maximum SE Burden							0.0668
No impairment	190	18.3	393	21.6	583	20.4
Minimal-mild impairment	429	41.2	745	40.9	1174	41.0
Moderate-marked impairment	320	30.8	544	29.9	864	30.2
Severe impairment-unable to function	101	9.7	139	7.6	240	8.4
Serious Adverse Events	50		66	3.6	116	4.0	0.1179
Death, non-suicide	2		1		3
Hospitalization for GMCs	25		33		58
Medical illness without hospitalization	1		3		4
Psychiatric hospitalization(substance abuse)	5		3		8
Psychiatric hospitalization(suicidal ideation)	12		24		36
Psychiatric hospitalization (worsening depression)	3		3		6
Psychiatric hospitalization(other)	0		2		2
Suicidal ideation (without hospitalization)	4		2		6
Any Psychiatric Serious Adverse Events	23	2.2	34	1.9	57	2.0	0.5170
Intolerance	191	18.3	299	16.3	490	17.0	0.1701

SE: Side Effect, GMCs: General Medical Conditions