Table 3. Iloperidone results (p-values) by trial, dose group, and diagnosis.

Trial Number/Measure	Primary Dose Group(s) (mg/d)	Schizophrenia+Schizoaffective Disorder (All Patients)		Schizophrenia Only (Post Hoc FDA Subset)		p-Value Highlighted in Journal Article
		Superiority versus Placebo	Inferiority versus Active Comparator	Superiority versus Placebo	Inferiority versus Active Comparator
3000	8+12	0.065	0.027	0.148	0.063	0.047 (12 mg only)
3004	10–16	0.001	0.034	0.306	0.021	0.001
3005	12–16	0.059	<0.001	0.033	0.005	0.09
	20–24	0.071	0.034	0.005	0.093	0.01
3101	24	Schizoaffective patients not recruited		0.007	FDA reported as statistically inferior without p-values	<0.01
Total number of positive trials		1	0	2	0	4
Total number negative or questionable trials		2	3	2	2	0
Meets FDA approval criterion of two or more positive trials		No	—	Yes	—	—

Statistically significant p-values (<0.05) are given in bold. Column at far right shows p-values from journal articles; all others are from the FDA review of iloperidone. See text for details.