Table 3.

Reasons for study discontinuation for all ITT patients in the overall population

						p-value
Variable	PBO N = 295 n (%)	LY40 N = 292 n (%)	LY80 N = 280 n (%)	RIS N = 142 n (%)	Total N = 1009 n (%)	Overall	LY40 vs. PBO	LY80 vs. PBO	RIS vs. PBO
Completed	171 (58.0)	143 (49.0)	129 (46.1)	96 (67.6)	539 (53.4)	<.001	0.032	0.005	0.059
Discontinued
Adverse Event-Physician Decision	24 (8.1)	18 (6.2)	29 (10.4)	10 (7.0)	81 (8.0)	0.322	0.424	0.389	0.849
Adverse Event-Subject Decision	9 (3.1)	6 (2.1)	7 (2.5)	2 (1.4)	24 (2.4)	0.770	0.603	0.802	0.515
Entry Criteria Not Met	1 (0.3)	1 (0.3)	0 (0.0)	0 (0.0)	2 (0.2)	>.999	>.999	>.999	>.999
Lost to follow up	9 (3.1)	4 (1.4)	6 (2.1)	3 (2.1)	22 (2.2)	0.576	0.262	0.604	0.759
Perceived Lack of Efficacy-Physician Decision	39 (13.2)	56 (19.2)	57 (20.4)	7 (4.9)	159 (15.8)	<.001	0.057	0.025	0.007
Perceived Lack of Efficacy-Subject Decision	9 (3.1)	14 (4.8)	12 (4.3)	3 (2.1)	38 (3.8)	0.499	0.296	0.508	0.759
Protocol Violation	5 (1.7)	10 (3.4)	7 (2.5)	3 (2.1)	25 (2.5)	0.616	0.202	0.568	0.718
Scheduling Conflict	1 (0.3)	1 (0.3)	0 (0.0)	0(0.0)	2 (0.2)	>.999	>.999	>.999	>.999
Sponsor Decision	1 (0.3)	1 (0.3)	1 (0.4)	0 (0.0)	3 (0.3)	>.999	>.999	>.999	>.999
Subject Decision-Consent Withdrawn	26 (8.8)	33 (11.3)	30 (10.7)	18 (12.7)	107 (10.6)	0.596	0.339	0.483	0.235
Subject is Moving or has Moved	0 (0.0)	4 (1.4)	1 (0.4)	0 (0.0)	5 (0.5)	0.082	0.061	0.487
Transportation Issues	0 (0.0)	1 (0.3)	1 (0.4)	0 (0.0)	2 (0.2)	0.668	0.497	0.487

Abbreviations: ITT intent-to-treat, N/n number of patients.

Groups: PBO = placebo; LY40 = LY2140023 monohydrate 40 mg; LY80 = LY2140023 monohydrate 80 mg; RIS = risperidone.

Note: p-values are calculated from Fisher's exact test.