Table 2.

Incidence of the Primary Composite Neuropsychiatric Endpoint and Its Components

	Psychotic Disorders (n=386)				Anxiety Disorders (n=782)				Mood Disorders (n=2882))
	Varenicline (n=95)	Bupropion (n=96)	Nicotine patch (n=99)	Placebo (n=96)	Varenicline (n=193)	Bupropion (n=200)	Nicotine patch (n=195)	Placebo (n=194)	Varenicline (n=731)	Bupropion (n=716)	Nicotine patch (n=713)	Placebo (n=722)
Observed Incidence of the Primary Composite NPS Endpoint	6 (6.3)	6 (6.3)	5 (5.1)	6 (6.3)	11 (5.7)	16 (8.0)	9 (4.6)	11 (5.7)	50 (6.8)	46 (6.4)	40 (5.6)	33 (4.6)
Estimated Primary Composite NPS Endpoint (%[95% CI])	6.2 (1.6 to 10.8)	8.0 (3.3 to 12.8)	6.4 (2.3 to 10.5)	7.3 (2.8 to 11.8)	6.5 (3.3 to 9.6)	8.7 (4.9 to 12.5)	3.8 (0.8 to 6.8)	6.1 (2.9 to 9.3)	7.7 (5.7 to 9.6)	6.9 (5.0 to 8.7)	6.8 (5.0 to 8.6)	5.9 (4.3 to 7.5)
Observed Events-All Components of Primary Composite NPS Endpoint
Anxiety	0	0	1 (1.0)	0	1 (0.5)	3 (1.5)	2 (1.0)	0	4 (0.5)	1 (0.1)	3 (0.4)	2 (0.3)
Depression	1 (1.1)	0	0	1 (1.0)	1 (0.5)	1 (0.5)	1 (0.5)	1 (0.5)	4 (0.5)	3 (0.4)	6 (0.8)	4 (0.6)
Feeling abnormal	0	0	0	0	0	0	0	0	0	1 (0.1)	0	0
Hostility	0	0	0	0	0	0	0	0	0	0	0	0
Agitation	2 (2.1)	2 (2.1)	1 (1.0)	1 (1.0)	4 (2.1)	7 (3.5)	2 (1.0)	5 (2.6)	19 (2.6)	20 (2.8)	18 (2.5)	16 (2.2)
Aggression	2 (2.1)	0	0	2 (2.1)	3 (1.6)	3 (1.5)	2 (1.0)	3 (1.5)	9 (1.2)	6 (0.8)	5 (0.7)	3 (0.4)
Delusions	1 (1.1)	0	1 (1.0)	0	0	0	0	0	0	1 (0.1)	0	0
Hallucinations	2 (2.1)	2 (2.1)	1 (1.0)	0	1 (0.5)	0	0	1 (0.5)	2 (0.3)	2 (0.3)	1 (0.1)	1 (0.1)
Homicidal ideation	0	0	0	0	0	0	0	0	0	0	0	0
Mania	0	1 (1.0)	0	1 (1.0)	1 (0.5)	0	1 (0.5)	1 (0.5)	6 (0.8)	8 (1.1)	2 (0.3)	4 (0.6)
Panic	0	1 (1.0)	1 (1.0)	0	1 (0.5)	6 (3.0)	3 (1.5)	2 (1.0)	6 (0.8)	9 (1.3)	9 (1.3)	5 (0.7)
Paranoia	1 (1.1)	0	0	1 (1.0)	0	0	0	0	0	0	0	1 (0.1)
Psychosis	1 (1.1)	1 (1.0)	2 (2.0)	1 (1.0)	0	0	1 (0.5)	0	3 (0.4)	1 (0.1)	0	0
Suicidal behavior	0	0	0	0	0	0	0	0	1 (0.1)	1 (0.1)	0	1 (0.1)
Suicidal ideation	0	1 (1.0)	1 (1.0)	0	2 (1.0)	1 (0.5)	1 (0.5)	0	3 (0.4)	0	2 (0.3)	2 (0.3)
Completed suicide	0	0	0	0	0	0	0	0	0	0	0	0