Trial Outcomes & Findings for Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia (NCT NCT01662648)

Last Updated: 2014-05-05

Results Overview

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

1117 participants

Primary outcome timeframe

Baseline and Week 26

Results posted on

2014-05-05

Participant Flow

Participant milestones

Participant milestones
Measure	Paliperidone ER: Lack of Efficacy Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Study STARTED	520	597
Overall Study COMPLETED	373	419
Overall Study NOT COMPLETED	147	178

Reasons for withdrawal

Reasons for withdrawal
Measure	Paliperidone ER: Lack of Efficacy Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Overall Study Death	1	3
Overall Study Adverse Event	40	37
Overall Study Lack of Efficacy	17	16
Overall Study Participant ineligible to continue trial	1	1
Overall Study Lost to Follow-up	24	36
Overall Study Withdrawal by Subject	36	53
Overall Study Participant non-compliant	16	20
Overall Study Other	8	11
Overall Study Adverse event and lack of efficacy (LOE)	3	0
Overall Study LOE and other reason unspecified	1	0
Overall Study LOE and Participant non-compliant	0	1

Baseline Characteristics

Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Paliperidone ER: Lack of Efficacy n=520 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=597 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.	Total n=1117 Participants Total of all reporting groups
Age, Customized Less than (<) 25 years	92 Participants 11.63 • n=93 Participants	125 Participants 11.90 • n=4 Participants	217 Participants n=27 Participants
Age, Customized Greater than or equal to (>=) 25 to < 35 years	153 Participants n=93 Participants	191 Participants n=4 Participants	344 Participants n=27 Participants
Age, Customized >= 35 to < 45 years	152 Participants n=93 Participants	152 Participants n=4 Participants	304 Participants n=27 Participants
Age, Customized >= 45 to < 55 years	83 Participants n=93 Participants	87 Participants n=4 Participants	170 Participants n=27 Participants
Age, Customized >= 55 to < 65 years	33 Participants n=93 Participants	34 Participants n=4 Participants	67 Participants n=27 Participants
Age, Customized >= 65 to < 75 years	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Age, Customized Greater than 75 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Sex: Female, Male Female	192 Participants n=93 Participants	268 Participants n=4 Participants	460 Participants n=27 Participants
Sex: Female, Male Male	328 Participants n=93 Participants	329 Participants n=4 Participants	657 Participants n=27 Participants

PRIMARY outcome

Timeframe: Baseline and Week 26

Population: Intent to Treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=508 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 Baseline	85.19 units on a scale Standard Deviation 24.97	65.45 units on a scale Standard Deviation 28.48
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 Week 26	-26.60 units on a scale Standard Deviation 28.24	-20.52 units on a scale Standard Deviation 30.05

SECONDARY outcome

Timeframe: Week 26

Population: ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.

The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=508 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26	72.83 percentage of participants	71.87 percentage of participants

SECONDARY outcome

Timeframe: Baseline and Week 26

The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=508 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in PANSS Total Positive Subscale Score at Week 26 Baseline	21.04 units on a scale Standard Deviation 7.15	15.26 units on a scale Standard Deviation 7.53
Change From Baseline in PANSS Total Positive Subscale Score at Week 26 Week 26	-7.17 units on a scale Standard Deviation 7.67	-5.07 units on a scale Standard Deviation 7.88

SECONDARY outcome

Timeframe: Baseline and Week 26

The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=508 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in PANSS Total Negative Subscale Score at Week 26 Baseline	22.73 units on a scale Standard Deviation 7.86	16.90 units on a scale Standard Deviation 8.13
Change From Baseline in PANSS Total Negative Subscale Score at Week 26 Week 26	-6.93 units on a scale Standard Deviation 7.96	-5.32 units on a scale Standard Deviation 8.12

SECONDARY outcome

Timeframe: Baseline and Week 26

The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=508 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26 Baseline	4.24 units on a scale Standard Deviation 0.83	3.29 units on a scale Standard Deviation 1.12
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26 Week 26	-1.12 units on a scale Standard Deviation 1.28	-0.98 units on a scale Standard Deviation 1.30

SECONDARY outcome

Timeframe: Baseline and Week 26

The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=506 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26 Baseline (n= 506, 583)	55.07 units on a scale Standard Deviation 15.68	66.03 units on a scale Standard Deviation 15.65
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26 Week 26 (n= 501, 574)	13.76 units on a scale Standard Deviation 17.80	11.14 units on a scale Standard Deviation 17.53

SECONDARY outcome

Timeframe: Baseline and Week 26

Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=507 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=581 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in Sleep Quality at Week 26 Baseline (n= 507, 581)	63.53 millimeter (mm) Standard Deviation 27.37	67.40 millimeter (mm) Standard Deviation 27.13
Change From Baseline in Sleep Quality at Week 26 Week 26 (n= 504, 574)	11.57 millimeter (mm) Standard Deviation 35.70	8.19 millimeter (mm) Standard Deviation 35.93

SECONDARY outcome

Timeframe: Baseline and Week 26

Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=507 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=581 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Change From Baseline in Daytime Drowsiness at Week 26 Baseline (n= 507, 581 )	32.80 millimeter (mm) Standard Deviation 27.56	34.54 millimeter (mm) Standard Deviation 28.61
Change From Baseline in Daytime Drowsiness at Week 26 Week 26 (n= 504, 574)	-9.52 millimeter (mm) Standard Deviation 32.29	-11.54 millimeter (mm) Standard Deviation 34.53

SECONDARY outcome

Timeframe: Baseline and Week 26

Population: ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure and "n" signifies those participants who were evaluated for this measure at specified time point.

Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.

Outcome measures

Outcome measures
Measure	Paliperidone ER: Lack of Efficacy n=507 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=583 Participants Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Number of Participants Within Each Category of Patient Satisfaction Score Very Good: Week 26 (n=492, 563)	120 participants	156 participants
Number of Participants Within Each Category of Patient Satisfaction Score Good: Week 26 (n=492, 563)	173 participants	253 participants
Number of Participants Within Each Category of Patient Satisfaction Score Reasonable: Week 26 (n=492, 563)	112 participants	94 participants
Number of Participants Within Each Category of Patient Satisfaction Score Moderate: Week 26 (n=492, 563)	70 participants	50 participants
Number of Participants Within Each Category of Patient Satisfaction Score Poor: Week 26 (n=492, 563)	17 participants	10 participants
Number of Participants Within Each Category of Patient Satisfaction Score Very Good: Baseline (n= 507, 583)	8 participants 32.74	21 participants 34.67
Number of Participants Within Each Category of Patient Satisfaction Score Good: Baseline (n= 507, 583)	74 participants	151 participants
Number of Participants Within Each Category of Patient Satisfaction Score Reasonable: Baseline (n= 507, 583)	256 participants	305 participants
Number of Participants Within Each Category of Patient Satisfaction Score Moderate: Baseline (n= 507, 583)	158 participants	97 participants
Number of Participants Within Each Category of Patient Satisfaction Score Poor: Baseline (n= 507, 583)	11 participants	9 participants

Adverse Events

Paliperidone ER: Lack of Efficacy

Serious events: 35 serious events

Other events: 208 other events

Deaths: 0 deaths

Paliperidone ER: Lack of Tolerability, Compliance or Other

Serious events: 29 serious events

Other events: 239 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

Regional Medical Franchis Director AP

Janssen China

Phone: +86 10 582 187 66

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Paliperidone ER: Lack of Efficacy n=512 participants at risk Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=587 participants at risk Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Psychiatric disorders Schizophrenia	2.3% 12/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.2% 7/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Psychotic disorder	1.4% 7/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.51% 3/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Aggression	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.34% 2/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Agitation	0.39% 2/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Hallucination	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Suicidal behaviour	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Abnormal behaviour	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Delusion	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Delusion of grandeur	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Grandiosity	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Hallucination, auditory	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Hostility	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Mania	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Schizoaffective disorder	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Schizophrenia, disorganized type	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Extrapyramidal disorder	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.51% 3/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Cerebrovascular accident	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Akathisia	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Dyskinesia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Dystonia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Poor quality sleep	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Speech disorder	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Tremor	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Vomiting	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.34% 2/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Nausea	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Gastritis	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Gastrointestinal haemorrhage	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Intestinal obstruction	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Investigations Investigation	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.34% 2/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Investigations Weight decreased	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Metabolism and nutrition disorders Anorexia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Metabolism and nutrition disorders Diabetes mellitus	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Metabolism and nutrition disorders Hypokalaemia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Respiratory, thoracic and mediastinal disorders Tachypnoea	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
General disorders	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.34% 2/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Cardiac disorders Cardiac arrest	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Eye disorders Oculogyration	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Injury, poisoning and procedural complications Poisoning	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Skin and subcutaneous tissue disorders Rash	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Infections and infestations Paronychia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Injury, poisoning and procedural complications Drowning	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Metabolism and nutrition disorders Diabetes mellitus inadequate control	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.17% 1/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Convulsion	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Acute psychosis	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Respiratory, thoracic and mediastinal disorders Asthma	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Vascular disorders Hypotension	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Investigations Blood pressure increased	0.20% 1/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.

Measure	Paliperidone ER: Lack of Efficacy n=512 participants at risk Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy.	Paliperidone ER: Lack of Tolerability, Compliance or Other n=587 participants at risk Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons.
Nervous system disorders Extrapyramidal disorder	6.6% 34/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	3.6% 21/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Headache	4.5% 23/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	4.1% 24/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Dizziness	3.1% 16/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	3.7% 22/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Akathisia	2.5% 13/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	3.1% 18/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Somnolence	1.8% 9/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	3.4% 20/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Tremor	1.8% 9/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	2.0% 12/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Parkinsonism	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Nervous system disorders Poor quality sleep	1.8% 9/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Insomnia	9.8% 50/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	11.6% 68/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Restlessness	1.8% 9/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	2.2% 13/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Anxiety	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.5% 9/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Psychotic disorder	1.8% 9/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	0.00% 0/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Psychiatric disorders Depression	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Nausea	3.3% 17/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	3.9% 23/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Vomiting	2.9% 15/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	2.7% 16/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Salivary hypersecretion	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.2% 7/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Gastrointestinal disorders Constipation	1.6% 8/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.4% 8/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
General disorders Pyrexia	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.5% 9/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.4% 8/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Investigations Weight increased	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.5% 9/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Reproductive system and breast disorders Amenorrhoea	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.2% 7/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Skin and subcutaneous tissue disorders Rash	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Eye disorders Oculogyration	0.00% 0/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.
Cardiac disorders Palpitations	1.2% 6/512 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.	1.0% 6/587 • 26 weeks Safety population included all the participants who received paliperidone extended-release (ER) at least once and provided any post-baseline information.