Trial Outcomes & Findings for 15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated (NCT NCT01157351)
NCT ID: NCT01157351
Last Updated: 2015-04-24
Results Overview
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
450 participants
Primary outcome timeframe
From date of randomization up to Month 15
Results posted on
2015-04-24
Participant Flow
Participant milestones
| Measure |
Paliperidone Palmitate
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Overall Study
STARTED
|
230
|
220
|
|
Overall Study
Treated
|
226
|
218
|
|
Overall Study
COMPLETED
|
93
|
88
|
|
Overall Study
NOT COMPLETED
|
137
|
132
|
Reasons for withdrawal
| Measure |
Paliperidone Palmitate
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
53
|
55
|
|
Overall Study
Withdrawal by Subject
|
37
|
27
|
|
Overall Study
Physician Decision
|
5
|
4
|
|
Overall Study
Protocol Violation
|
0
|
1
|
|
Overall Study
Other
|
32
|
36
|
|
Overall Study
Noncompliance with Study Drug
|
0
|
3
|
|
Overall Study
Randomized but not Treated
|
4
|
2
|
Baseline Characteristics
15 Month Study for Adults Who Have Been Diagnosed With Schizophrenia and Incarcerated
Baseline characteristics by cohort
| Measure |
Paliperidone Palmitate
n=226 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
Total
n=444 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
37.7 years
STANDARD_DEVIATION 10.57 • n=5 Participants
|
38.6 years
STANDARD_DEVIATION 10.36 • n=7 Participants
|
38.1 years
STANDARD_DEVIATION 10.47 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
193 Participants
n=5 Participants
|
190 Participants
n=7 Participants
|
383 Participants
n=5 Participants
|
|
Baseline Personal and Social Performance (PSP) Total Score
|
54.8 Units on a scale
STANDARD_DEVIATION 12.83 • n=5 Participants
|
55.0 Units on a scale
STANDARD_DEVIATION 12.73 • n=7 Participants
|
54.9 Units on a scale
STANDARD_DEVIATION 12.76 • n=5 Participants
|
|
Baseline Clinical Global Impression - Severity (CGI-S) Total Score
|
3.8 Units on a scale
STANDARD_DEVIATION 0.80 • n=5 Participants
|
3.9 Units on a scale
STANDARD_DEVIATION 0.70 • n=7 Participants
|
3.8 Units on a scale
STANDARD_DEVIATION 0.75 • n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization up to Month 15Population: Explanatory Intent-to-Treat (eITT) population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day.
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Outcome measures
| Measure |
Paliperidone Palmitate
n=226 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Time to First Treatment Failure
|
416 Days
Interval 285.0 to
Upper limit of 95 percent (%) confidence interval was not estimable due to insufficient number of participants with event.
|
226 Days
Interval 147.0 to 304.0
|
PRIMARY outcome
Timeframe: From date of randomization up to Month 15Population: eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day.
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
Outcome measures
| Measure |
Paliperidone Palmitate
n=226 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Treatment Failure Due to Any Event
|
39.8 percentage of participants
|
53.7 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Arrest/incarceration
|
21.2 percentage of participants
|
29.4 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Psychiatric hospitalization
|
8.0 percentage of participants
|
11.9 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
D/C due to safety/tolerability
|
6.6 percentage of participants
|
3.7 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Treatment supplementation
|
2.2 percentage of participants
|
2.8 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
D/C due to inadequate efficacy
|
0.4 percentage of participants
|
4.1 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Increase in level of psychiatric services
|
1.3 percentage of participants
|
1.8 percentage of participants
|
|
Percentage of Participants in Each Event Category of First Treatment Failure
Suicide
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: From date of randomization up to Month 15Population: eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day.
A time to parameter looking only at 2 component events of treatment failure: arrest or incarceration, and psychiatric hospitalization. An arrest was defined as the taking of a participant into custody by legal authority, for any reason. Incarceration was defined as involuntary confinement by an officer of the law. Psychiatric hospitalization was an inpatient psychiatric hospitalization that occurred due to the participant's clinically significant worsening of symptoms of schizophrenia.
Outcome measures
| Measure |
Paliperidone Palmitate
n=226 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Time to First Psychiatric Hospitalization or Arrest/Incarceration
|
NA Days
Median and 95% confidence interval was not estimable due to insufficient number of participants with event.
|
274 Days
Interval 202.0 to 407.0
|
SECONDARY outcome
Timeframe: Baseline up to Month 15Population: eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
The PSP score assesses the degree of difficulty a participant exhibit over a 1 month period within 4 domains of behavior: a) socially useful activities, b) personal and social relationships, c) self-care, and d) disturbing and aggressive behavior. The investigators rate participants' degree of difficulty in each of the 4 domains using a 6-point Likert scale (from 0=absent to 5=very severe). The domain ratings were then transformed to PSP total score ranging from 1 to 100. Higher PSP total scores denote better functioning. A score between 71 and 100 represents normal to mild degree of dysfunction; a score between 31 and 70 represents varying degree of difficulty; and a score \<=30 represents poor function that requires intensive supervision.
Outcome measures
| Measure |
Paliperidone Palmitate
n=203 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=185 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration
|
5.75 Units on a scale
Standard Error 0.690
|
5.36 Units on a scale
Standard Error 0.690
|
SECONDARY outcome
Timeframe: From date of randomization up to Month 15Population: eITT population included all ITT participants who had their study assessments for time period between randomization date and eITT end point. The eITT end point for paliperidone palmitate was the last injection date+28 days and for oral antipsychotics was the last prescription date + the number of days' supply + 1 day.
A time-to parameter looking only at 1 component event of treatment failure: psychiatric hospitalization. Time to first psychiatric hospitalization was admission date of the psychiatric hospitalization recorded in the "Assessment of Treatment Failure - Psychiatric Hospitalization."
Outcome measures
| Measure |
Paliperidone Palmitate
n=226 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Time to First Psychiatric Hospitalization
|
NA Days
Median and 95% confidence interval was not estimable due to insufficient number of participants with event.
|
NA Days
Median and 95% confidence interval was not estimable due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Baseline up to Month 15Population: eITT population. 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure.
The CGI-S rating scale was a 7-point global assessment of symptom severity with scores determined by clinician as follows: 1=Not ill, 2=Very Mild, 3= Mild, 4= Moderate, 5= Marked, 6= Severe, and 7= Extremely Severe. The higher the score the worse the illness.
Outcome measures
| Measure |
Paliperidone Palmitate
n=219 Participants
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=205 Participants
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration
|
-0.48 Units on a scale
Standard Error 0.038
|
-0.43 Units on a scale
Standard Error 0.037
|
Adverse Events
Paliperidone Palmitate
Serious events: 42 serious events
Other events: 178 other events
Deaths: 0 deaths
Oral Antipsychotics
Serious events: 53 serious events
Other events: 155 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Paliperidone Palmitate
n=226 participants at risk
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 participants at risk
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Haematemesis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Intestinal Obstruction
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Asthenia
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Chest Pain
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Drug Withdrawal Syndrome
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Non-cardiac Chest Pain
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Sudden Death
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Acquired Immunodeficiency Syndrome
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Cellulitis
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Cholecystitis Infective
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
H1N1 Influenza
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
HIV Infection
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Pneumonia
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Sepsis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Wound Infection
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Alcohol Poisoning
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Gun Shot Wound
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Intentional Overdose
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Perirenal Haematoma
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic Brain Injury
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Traumatic Lung Injury
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric Cancer Stage III
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Akathisia
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Cerebellar Ataxia
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Dystonia
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Encephalitis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Epilepsy
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Facial Paresis
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Ischaemic Stroke
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Syncope
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Pregnancy, puerperium and perinatal conditions
Stillbirth
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Acute Psychosis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.92%
2/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Agitation
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Alcohol Withdrawal Syndrome
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Alcoholism
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Delusion
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Depression
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Depression Suicidal
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Depressive Symptom
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Factitious Disorder
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Hallucinations, Mixed
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Mania
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Mental Status Changes
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Paranoia
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Polysubstance Dependence
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Psychotic Behaviour
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Psychotic Disorder
|
4.9%
11/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.2%
7/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Schizoaffective Disorder Bipolar Type
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Schizophrenia
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
5.0%
11/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Substance Abuse
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Suicidal Ideation
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
5.0%
11/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Suicide Attempt
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.92%
2/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Status Asthmaticus
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Vascular disorders
Hypertension
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
Other adverse events
| Measure |
Paliperidone Palmitate
n=226 participants at risk
Intramuscular injection, 234 milligram (mg) on Day 1, 156 mg on Day 8, followed by flexible monthly maintenance dosing as per investigator's discretion starting on Day 38 up to 15 months.
|
Oral Antipsychotics
n=218 participants at risk
One of 7 oral antipsychotics (aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone) that the investigator specified as appropriate for the participant was administered as per clinical practice for up to 15 months.
|
|---|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.8%
4/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
0.00%
0/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Constipation
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.7%
8/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.2%
7/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Dry Mouth
|
6.6%
15/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
8.3%
18/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Dyspepsia
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
9/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Salivary Hypersecretion
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Toothache
|
4.9%
11/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
6.0%
13/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Gastrointestinal disorders
Vomiting
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Fatigue
|
7.5%
17/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Injection Site Pain
|
18.6%
42/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Irritability
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
General disorders
Pain
|
0.44%
1/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Bronchitis
|
2.7%
6/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Influenza
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Nasopharyngitis
|
6.6%
15/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
6.4%
14/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.8%
13/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
5.0%
11/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Joint Sprain
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Injury, poisoning and procedural complications
Laceration
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
5.5%
12/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Investigations
Blood Prolactin Increased
|
4.9%
11/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.92%
2/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Investigations
Semen Volume Decreased
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Investigations
Weight Increased
|
13.3%
30/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
7.3%
16/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Metabolism and nutrition disorders
Abnormal Weight Gain
|
4.9%
11/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.8%
4/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Metabolism and nutrition disorders
Increased Appetite
|
7.1%
16/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.7%
8/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
5.8%
13/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.7%
8/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
4.0%
9/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.7%
8/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Akathisia
|
11.5%
26/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
7.8%
17/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Dizziness
|
2.7%
6/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
5.0%
11/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Dyskinesia
|
2.7%
6/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.8%
4/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Dystonia
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Extrapyramidal Disorder
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.8%
4/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Headache
|
7.5%
17/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
8.7%
19/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Sedation
|
6.6%
15/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
8.3%
18/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Somnolence
|
4.4%
10/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
7.3%
16/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Nervous system disorders
Tremor
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Agitation
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.3%
5/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Anxiety
|
11.1%
25/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
8.3%
18/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Depression
|
8.4%
19/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
7.8%
17/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Hallucination, Auditory
|
1.3%
3/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Insomnia
|
18.6%
42/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
12.4%
27/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Libido Decreased
|
5.8%
13/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
1.4%
3/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Schizophrenia
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Psychiatric disorders
Suicidal Ideation
|
1.8%
4/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
4.1%
9/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Reproductive system and breast disorders
Erectile Dysfunction
|
7.5%
17/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Reproductive system and breast disorders
Galactorrhoea
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.1%
7/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
2.8%
6/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.7%
6/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.46%
1/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.2%
5/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
0.00%
0/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
|
Vascular disorders
Hypertension
|
0.88%
2/226
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
3.7%
8/218
Intent to Treat (ITT) population included all participants who were randomly assigned to treatment and who received at least 1 dose of their randomly assigned study treatment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60