Trial Outcomes & Findings for To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770) (NCT NCT00150176)

NCT ID: NCT00150176

Last Updated: 2022-02-08

Results Overview

A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 831 participants
• Primary outcome timeframe: time of first relapse up to Day 182 (double blind phase)
• Results posted on: 2022-02-08

Participant Flow

Prior to randomization, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). Only subjects who had continued stable presentation of symptoms during this phase were randomized into the double-blind phase.

Participant milestones

Measure	Asenapine Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Overall Study STARTED	194	192
Overall Study COMPLETED	135	72
Overall Study NOT COMPLETED	59	120

Reasons for withdrawal

Measure	Asenapine Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Overall Study Adverse Event	16	53
Overall Study Relapse/Impending relapse, non-AE	10	39
Overall Study Withdrawal by Subject	19	12
Overall Study Lost to Follow-up	3	3
Overall Study OTHER	11	13

Baseline Characteristics

To Determine Long Term Efficacy and Safety of Asenapine in Schizophrenic Patient Population (A7501012)(COMPLETED)(P05770)

Baseline characteristics by cohort

Measure	Asenapine n=194 Participants Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo n=192 Participants Baseline for the double-blind period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.	Total n=386 Participants Total of all reporting groups
Age, Continuous	39.2 years STANDARD_DEVIATION 12.53 • n=5 Participants	38.7 years STANDARD_DEVIATION 11.64 • n=7 Participants	38.9 years STANDARD_DEVIATION 12.08 • n=5 Participants
Sex: Female, Male Female	89 Participants n=5 Participants	76 Participants n=7 Participants	165 Participants n=5 Participants
Sex: Female, Male Male	105 Participants n=5 Participants	116 Participants n=7 Participants	221 Participants n=5 Participants

PRIMARY outcome

Timeframe: time of first relapse up to Day 182 (double blind phase)

Population: ITT population, excluding subjects not treated and w/ past enrollment in an asenapine trial. As trial progressed \& subjects discont'd for various reasons, subjects at risk for relapse decreased from 190 each arm (Day 1) to 70 at risk in placebo arm and 135 subjects in asenapine arm (Day 182). Those relapsing \>3 days after last dose also excluded.

A relapse or impending relapse was declared if a subject meets 1 of 3 "symptomatic relapse criteria" which were all based on a combination of the Positive and Negative Syndrome Scale (PANSS) total score or PANSS items, and Clinical Global Impression-Severity (CGI-S); or if in the opinion of the investigator, the subject's symptoms of schizophrenia had deteriorated to such an extent or the risk of violence to self or others or risk of suicide had increased so that certain prespecified measures were necessary.

Outcome measures

Measure	Asenapine n=190 Participants Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo n=190 Participants Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Time to Relapse or an Impending Relapse Days 85 - 91 (N asenapine = 158; N placebo = 110)	0 relapses	4 relapses
Time to Relapse or an Impending Relapse Days 71 - 77 (N asenapine = 161; N placebo = 117)	1 relapses	4 relapses
Time to Relapse or an Impending Relapse Days 113 - 119 (N asenapine = 149; N placebo = 95)	2 relapses	3 relapses
Time to Relapse or an Impending Relapse Days 1 - 7 (N asenapine = 190; N placebo = 190)	0 relapses	3 relapses
Time to Relapse or an Impending Relapse Days 8 - 14 (N asenapine = 188; N placebo = 186)	1 relapses	14 relapses
Time to Relapse or an Impending Relapse Days 15 - 21 (N asenapine = 183; N placebo = 170)	2 relapses	9 relapses
Time to Relapse or an Impending Relapse Days 22 - 28 (N asenapine = 180; N placebo = 160)	2 relapses	8 relapses
Time to Relapse or an Impending Relapse Days 57 - 63 (N asenapine = 165; N placebo = 123)	1 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 64 - 70 (N asenapine = 163; N placebo = 120)	2 relapses	3 relapses
Time to Relapse or an Impending Relapse Days 78 - 84 (N asenapine = 160; N placebo = 113)	2 relapses	2 relapses
Time to Relapse or an Impending Relapse Days 92 - 98 (N asenapine = 154; N placebo = 104)	0 relapses	4 relapses
Time to Relapse or an Impending Relapse Days 99 - 105 (N asenapine = 151; N placebo = 99)	0 relapses	2 relapses
Time to Relapse or an Impending Relapse Days 106 - 112 (N asenapine = 151; N placebo = 96)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 120 - 126 (N asenapine = 147; N placebo = 87)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 127 - 133 (N asenapine = 147; N placebo = 86)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 134 - 140 (N asenapine = 146; N placebo = 84)	0 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 141 - 147 (N asenapine = 145; N placebo = 83)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 148 - 154 (N asenapine = 142; N placebo = 81)	0 relapses	5 relapses
Time to Relapse or an Impending Relapse Days 155 - 161 (N asenapine = 141; N placebo = 75)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 162 - 168 (N asenapine = 139; N placebo = 74)	1 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 169 - 175 (N asenapine = 137; N placebo = 72)	2 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 176 - 182 (N asenapine = 135; N placebo = 70)	0 relapses	1 relapses
Time to Relapse or an Impending Relapse Days 183 - 189 (N asenapine = 75; N placebo = 39)	0 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 190 - 196 (N asenapine = 9; N placebo = 9)	0 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 197 - 203 (N asenapine = 2; N placebo = 2)	0 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 204 - 210 (N asenapine = 0; N placebo = 1)	0 relapses	0 relapses
Time to Relapse or an Impending Relapse Days 36 - 42 (N asenapine = 175; N placebo = 140)	1 relapses	8 relapses
Time to Relapse or an Impending Relapse Days 43 - 49 (N asenapine = 173; N placebo = 130)	5 relapses	2 relapses
Time to Relapse or an Impending Relapse Days 50 - 56 (N asenapine = 166; N placebo = 127)	1 relapses	4 relapses
Time to Relapse or an Impending Relapse Days 29 - 35 (N asenapine = 175; N placebo = 149)	0 relapses	7 relapses

SECONDARY outcome

Timeframe: time of discontinuation up to Day 182 (double blind phase)

Population: Intent to treat (ITT) population, additionally excluding subjects not treated and excluding subjects with past enrollment in an asenapine trial.

The number of days to early discontinuation is the number of days from randomization to early discontinuation from the study for adverse event, relapse or impending relapse that was not considered an adverse event, withdrawal of informed consent, or lost to follow-up (without evidence of relapse).

Outcome measures

Measure	Asenapine n=191 Participants Double Blind Asenapine Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo n=191 Participants Double Blind Placebo Group. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.
Time to Early Discontinuation for Any Reason Days 36 - 42 (N asenapine = 176; N placebo = 143)	3 participants	7 participants
Time to Early Discontinuation for Any Reason Days 43 - 49 (N asenapine = 173; N placebo = 136)	7 participants	7 participants
Time to Early Discontinuation for Any Reason Days 85 - 91 (N asenapine = 158; N placebo = 113)	5 participants	8 participants
Time to Early Discontinuation for Any Reason Days 92 - 98 (N asenapine = 153; N placebo = 105)	2 participants	4 participants
Time to Early Discontinuation for Any Reason Days 120 - 126 (N asenapine = 148; N placebo = 88)	0 participants	1 participants
Time to Early Discontinuation for Any Reason Days 1 - 7 (N asenapine = 191; N placebo = 191)	1 participants	2 participants
Time to Early Discontinuation for Any Reason Days 8 - 14 (N asenapine = 190; N placebo = 189)	6 participants	14 participants
Time to Early Discontinuation for Any Reason Days 15 - 21 (N asenapine = 184; N placebo = 175)	3 participants	10 participants
Time to Early Discontinuation for Any Reason Days 22 - 28 (N asenapine = 181; N placebo = 165)	5 participants	11 participants
Time to Early Discontinuation for Any Reason Days 29 - 35 (N asenapine = 176; N placebo = 154)	0 participants	11 participants
Time to Early Discontinuation for Any Reason Days 50 - 56 (N asenapine = 166; N placebo = 129)	0 participants	3 participants
Time to Early Discontinuation for Any Reason Days 57 - 63 (N asenapine = 166; N placebo = 126)	3 participants	4 participants
Time to Early Discontinuation for Any Reason Days 64 - 70 (N asenapine = 163; N placebo = 122)	1 participants	2 participants
Time to Early Discontinuation for Any Reason Days 71 - 77 (N asenapine = 162; N placebo = 120)	0 participants	4 participants
Time to Early Discontinuation for Any Reason Days 78 - 84 (N asenapine = 162; N placebo = 116)	4 participants	3 participants
Time to Early Discontinuation for Any Reason Days 99 - 105 (N asenapine = 150; N placebo = 100)	0 participants	2 participants
Time to Early Discontinuation for Any Reason Days 106 - 112 (N asenapine = 150; N placebo = 98)	1 participants	1 participants
Time to Early Discontinuation for Any Reason Days 113 - 119 (N asenapine = 149; N placebo = 97)	1 participants	8 participants
Time to Early Discontinuation for Any Reason Days 127 - 133 (N asenapine = 148; N placebo = 87)	2 participants	0 participants
Time to Early Discontinuation for Any Reason Days 134 - 140 (N asenapine = 146; N placebo = 86)	0 participants	1 participants
Time to Early Discontinuation for Any Reason Days 141 - 147 (N asenapine = 145; N placebo = 84)	3 participants	1 participants
Time to Early Discontinuation for Any Reason Days 148 - 154 (N asenapine = 142; N placebo = 82)	1 participants	3 participants
Time to Early Discontinuation for Any Reason Days 155 - 161 (N asenapine = 141; N placebo = 78)	1 participants	3 participants
Time to Early Discontinuation for Any Reason Days 162 - 168 (N asenapine = 139; N placebo = 75)	2 participants	1 participants
Time to Early Discontinuation for Any Reason Days 169 - 175 (N asenapine = 137; N placebo = 73)	2 participants	1 participants
Time to Early Discontinuation for Any Reason Days 176 - 182 (N asenapine = 135; N placebo = 71)	0 participants	1 participants
Time to Early Discontinuation for Any Reason Days 183 - 189 (N asenapine = 75; N placebo = 39)	0 participants	0 participants
Time to Early Discontinuation for Any Reason Days 190 - 196 (N asenapine = 9; N placebo = 9)	0 participants	0 participants
Time to Early Discontinuation for Any Reason Days 197 - 203 (N asenapine = 2; N placebo = 2)	0 participants	0 participants
Time to Early Discontinuation for Any Reason Days 204 - 210 (N asenapine = 0; N placebo = 1)	0 participants	0 participants

Adverse Events

Asenapine

Serious events: 6 serious events

Other events: 121 other events

Deaths: 0 deaths

Placebo

Serious events: 22 serious events

Other events: 127 other events

Deaths: 0 deaths

Asenapine During Open-Label Phase and Not Randomized

Serious events: 39 serious events

Other events: 170 other events

Deaths: 0 deaths

Serious adverse events

Measure	Asenapine n=194 participants at risk Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo n=192 participants at risk Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.	Asenapine During Open-Label Phase and Not Randomized n=314 participants at risk Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase \& Not Randomized' Group includes subjects who received \>= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
Gastrointestinal disorders DYSPHAGIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Gastrointestinal disorders INGUINAL HERNIA, OBSTRUCTIVE	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
General disorders HYPOTHERMIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
General disorders NON-CARDIAC CHEST PAIN	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations ADNEXITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations APPENDICITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations BRONCHITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.64% 2/314 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations EXTERNAL EAR CELLULITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations GASTROENTERITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations PNEUMONIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.64% 2/314 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Infections and infestations SEPSIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications ACCIDENTAL OVERDOSE	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications FALL	0.52% 1/194 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications OVERDOSE	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications RADIUS FRACTURE	0.52% 1/194 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications ROAD TRAFFIC ACCIDENT	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Injury, poisoning and procedural complications SPINAL CORD INJURY	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Investigations BLOOD GLUCOSE DECREASED	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Metabolism and nutrition disorders DIABETES MELLITUS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Metabolism and nutrition disorders DIABETES MELLITUS INADEQUATE CONTROL	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Metabolism and nutrition disorders HYPOGLYCAEMIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders CONVULSION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders DISTURBANCE IN ATTENTION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders POOR QUALITY SLEEP	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders TARDIVE DYSKINESIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders UNRESPONSIVE TO STIMULI	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders AGITATION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.64% 2/314 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders ANXIETY	0.52% 1/194 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders DEPRESSIVE SYMPTOM	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders HALLUCINATION, AUDITORY	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders HALLUCINATION, VISUAL	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders HOMICIDAL IDEATION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders MAJOR DEPRESSION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders PARANOIA	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders PSYCHOTIC DISORDER	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.64% 2/314 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SCHIZOPHRENIA	1.0% 2/194 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	4.7% 9/192 • Number of events 9 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.2% 10/314 • Number of events 11 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SCHIZOPHRENIA, PARANOID TYPE	1.0% 2/194 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.6% 7/192 • Number of events 7 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.5% 11/314 • Number of events 11 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SCHIZOPHRENIA, UNDIFFERENTIATED TYPE	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SUICIDAL IDEATION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SUICIDE ATTEMPT	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders THINKING ABNORMAL	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Reproductive system and breast disorders BALANOPOSTHITIS	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Respiratory, thoracic and mediastinal disorders RESPIRATORY FAILURE	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Skin and subcutaneous tissue disorders STEVENS-JOHNSON SYNDROME	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/192 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.32% 1/314 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Vascular disorders HYPERTENSION	0.00% 0/194 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.52% 1/192 • Number of events 1 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.00% 0/314 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.

Other adverse events

Measure	Asenapine n=194 participants at risk Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by asenapine 5 or 10 mg sublingual twice daily for 26 weeks in the double blind phase.	Placebo n=192 participants at risk Adverse Events for the Double Blind Period. Subjects received 26 weeks of open label asenapine treatment (cross titration period up to first 4 weeks, with target dose of 10 mg twice daily by week 1), followed by matching placebo sublingual twice daily for 26 weeks during the double-blind phase.	Asenapine During Open-Label Phase and Not Randomized n=314 participants at risk Adverse Events for the Open-Label period. The 'Asenapine During Open-Label Phase \& Not Randomized' Group includes subjects who received \>= 1 dose of asenapine during the 26 week open-label phase, and did NOT continue to double-blind phase.
Gastrointestinal disorders HYPOAESTHESIA ORAL	2.1% 4/194 • Number of events 5 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	5.2% 10/192 • Number of events 11 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.5% 11/314 • Number of events 11 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Gastrointestinal disorders NAUSEA	4.6% 9/194 • Number of events 10 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	5.2% 10/192 • Number of events 10 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	4.8% 15/314 • Number of events 15 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Investigations WEIGHT DECREASED	6.7% 13/194 • Number of events 13 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	10.9% 21/192 • Number of events 24 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	0.96% 3/314 • Number of events 3 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Investigations WEIGHT INCREASED	14.4% 28/194 • Number of events 30 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	10.9% 21/192 • Number of events 23 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.5% 11/314 • Number of events 11 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders AKATHISIA	6.7% 13/194 • Number of events 23 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.8% 13/192 • Number of events 20 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.7% 21/314 • Number of events 32 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders HEADACHE	10.8% 21/194 • Number of events 33 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	9.9% 19/192 • Number of events 28 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.1% 19/314 • Number of events 45 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders PARKINSONISM	5.2% 10/194 • Number of events 14 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.2% 12/192 • Number of events 18 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.8% 12/314 • Number of events 19 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders SEDATION	5.2% 10/194 • Number of events 14 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	5.2% 10/192 • Number of events 13 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.8% 12/314 • Number of events 16 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Nervous system disorders SOMNOLENCE	16.0% 31/194 • Number of events 43 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	17.2% 33/192 • Number of events 47 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	17.2% 54/314 • Number of events 65 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders AGITATION	6.2% 12/194 • Number of events 13 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	9.9% 19/192 • Number of events 20 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	7.6% 24/314 • Number of events 29 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders ANXIETY	12.9% 25/194 • Number of events 32 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	14.1% 27/192 • Number of events 46 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	10.8% 34/314 • Number of events 48 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders DELUSION	1.0% 2/194 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.2% 12/192 • Number of events 15 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	3.8% 12/314 • Number of events 13 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders DEPRESSION	6.7% 13/194 • Number of events 14 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	4.7% 9/192 • Number of events 12 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	4.8% 15/314 • Number of events 20 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders HALLUCINATION	1.0% 2/194 • Number of events 2 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	6.8% 13/192 • Number of events 15 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	1.9% 6/314 • Number of events 6 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders INSOMNIA	20.1% 39/194 • Number of events 48 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	24.5% 47/192 • Number of events 64 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	13.4% 42/314 • Number of events 56 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.
Psychiatric disorders SCHIZOPHRENIA	4.1% 8/194 • Number of events 8 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	13.0% 25/192 • Number of events 32 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.	2.5% 8/314 • Number of events 9 • Prior to randomization to the double-blind period, there was a 26 week open-label phase where 700 subjects received at least one dose of open-label asenapine (out of 831 initially enrolled). During the first 4 weeks of the open-label period, subjects could cross titrate. The target dose of asenapine was 10 mg twice daily by week 1. Only subjects who had continued stable presentation of symptoms during open-label phase were randomized into the double-blind phase (into Asenapine or Placebo arm). Remainder of subjects were not randomized.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Email: ClinicalTrialsDisclosure@merck.com

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