Trial Outcomes & Findings for PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia (NCT NCT00761189)
NCT ID: NCT00761189
Last Updated: 2014-03-05
Results Overview
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
COMPLETED
PHASE4
491 participants
Week 12
2014-03-05
Participant Flow
Participant milestones
| Measure |
Paliperidone
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Overall Study
STARTED
|
491
|
|
Overall Study
COMPLETED
|
306
|
|
Overall Study
NOT COMPLETED
|
185
|
Reasons for withdrawal
| Measure |
Paliperidone
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Overall Study
Adverse Event
|
42
|
|
Overall Study
Lack of Efficacy
|
45
|
|
Overall Study
Lost to Follow-up
|
36
|
|
Overall Study
Withdrawal by Subject
|
49
|
|
Overall Study
Other
|
13
|
Baseline Characteristics
PaliperidoNe Extended-Release [ER] Dosing and Clinical Response in Acute Schizophrenia
Baseline characteristics by cohort
| Measure |
Paliperidone
n=491 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Age, Continuous
|
36.7 years
STANDARD_DEVIATION 10.44 • n=5 Participants
|
|
Sex: Female, Male
Female
|
247 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
244 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=345 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
|
34.78 Percentage of participants
|
PRIMARY outcome
Timeframe: Week 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=260 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Percentage of Participants Assessed as Very Much Improved or Much Improved Based on Clinical Global Impression-Improvement (CGI-I) Scale - Per Protocol (PP) Population
|
41.92 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=345 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
Baseline
|
49.39 Units on a scale
Standard Deviation 14.69
|
|
Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
Week 4
|
59.44 Units on a scale
Standard Deviation 13.54
|
|
Personal and Social Performance (PSP) Scale Score - Intent-to-treat (ITT) Population
Week 12
|
62.76 Units on a scale
Standard Deviation 13.93
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and Week 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
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.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=260 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
Baseline
|
49.70 Units on a scale
Standard Deviation 14.73
|
|
Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
Week 4
|
60.27 Units on a scale
Standard Deviation 13.34
|
|
Personal and Social Performance (PSP) Scale Score - Per Protocol (PP) Population
Week 12
|
64.73 Units on a scale
Standard Deviation 13.09
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until Week 12 are reported here.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=345 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Intent-to-treat (ITT) Population
|
38.84 Percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
Percentage of participants who were continuously treated with paliperidone extended-release (ER) 6 milligram per day regimen until week 12 are reported here.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=260 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Percentage of Participants Continuously Treated With 6 Milligram Per Day Regimen Until Week 12 - Per Protocol (PP) Population
|
41.54 Percentage of Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=343 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
Baseline
|
-2.34 Units on a scale
Standard Deviation 4.78
|
|
Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
Week 4
|
-3.37 Units on a scale
Standard Deviation 4.53
|
|
Drug Attitude Inventory (DAI) Score - Intent-to-treat (ITT) Population
Week 12
|
-3.57 Units on a scale
Standard Deviation 4.54
|
SECONDARY outcome
Timeframe: Baseline, Week 4 and 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=259 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
Baseline
|
-2.39 Units on a scale
Standard Deviation 4.81
|
|
Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
Week 4
|
-3.49 Units on a scale
Standard Deviation 4.53
|
|
Drug Attitude Inventory (DAI) Score - Per Protocol (PP) Population
Week 12
|
-4.02 Units on a scale
Standard Deviation 4.26
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8 and 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
The CGI-S 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 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=345 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Week 4
|
3.73 Units on a scale
Standard Deviation 0.87
|
|
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Baseline
|
4.62 Units on a scale
Standard Deviation 0.70
|
|
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Week 2
|
4.08 Units on a scale
Standard Deviation 0.81
|
|
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Week 8
|
3.50 Units on a scale
Standard Deviation 0.91
|
|
Clinical Global Impression - Severity (CGI-S) Score - Intent-to-treat (ITT) Population
Week 12
|
3.29 Units on a scale
Standard Deviation 0.98
|
SECONDARY outcome
Timeframe: Baseline, Week 2, 4, 8 and 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol.
The CGI-S 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 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=260 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Baseline
|
4.60 Units on a scale
Standard Deviation 0.68
|
|
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Week 2
|
4.02 Units on a scale
Standard Deviation 0.81
|
|
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Week 4
|
3.66 Units on a scale
Standard Deviation 0.85
|
|
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Week 8
|
3.40 Units on a scale
Standard Deviation 0.87
|
|
Clinical Global Impression - Severity (CGI-S) Score - Per Protocol (PP) Population
Week 12
|
3.10 Units on a scale
Standard Deviation 0.91
|
SECONDARY outcome
Timeframe: Week 12Population: Intent to Treat (ITT) population for efficacy included all the eligible participants who received paliperidone extended-release (ER) at least once and who completed post baseline efficacy assessments.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=345 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Very much improved
|
5 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Much improved
|
115 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Minimally Improved
|
158 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
No change
|
46 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Minimally worse
|
15 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Much worse
|
6 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Intent-to-treat (ITT) Population
Very much worse
|
0 Participants
|
SECONDARY outcome
Timeframe: Week 12Population: Per protocol (PP) population included all the participants who received paliperidone extended-release (ER) at least once and who completed the clinical study without violating the study protocol. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The CGI-I is a 7-point scale that requires the clinician to assess how much the participant's illness has improved or worsened relative to a baseline state at the beginning of the intervention and rated as: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; 7=very much worse.
Outcome measures
| Measure |
Paliperidone Extended-release (ER)
n=260 Participants
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Very much improved
|
5 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Much improved
|
104 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Minimally Improved
|
118 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
No change
|
28 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Minimally worse
|
5 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Much worse
|
0 Participants
|
|
Number of Participants With Categorical Scores Based on Clinical Global Impression - Improvement (CGI-I) Scale - Per Protocol (PP) Population
Very much worse
|
0 Participants
|
Adverse Events
Paliperidone
Serious adverse events
| Measure |
Paliperidone
n=491 participants at risk
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Gastric Ulcer
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
General disorders
Chest Discomfort
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Hepatobiliary disorders
Hepatic Steatosis
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Accidental Overdose
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Fall
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Tendon Injury
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign Breast Neoplasm
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dizziness
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dystonia
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Headache
|
0.41%
2/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Tardive Dyskinesia
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Abnormal Behaviour
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Acute Psychosis
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Aggression
|
1.0%
5/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Agitation
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Alcohol Abuse
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Anxiety
|
0.81%
4/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Completed Suicide
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Delusion
|
0.61%
3/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination, Auditory
|
0.61%
3/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Insomnia
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Nicotine Dependence
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Obsessive Thoughts
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Obsessive-Compulsive Disorder
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Psychotic Disorder
|
0.41%
2/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Schizophrenia
|
2.6%
13/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Schizophrenia, Paranoid Type
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Social Avoidant Behaviour
|
0.61%
3/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Suicidal Ideation
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Suicide Attempt
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Social circumstances
Treatment Noncompliance
|
0.20%
1/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
Other adverse events
| Measure |
Paliperidone
n=491 participants at risk
Paliperidone extended-release (ER) tablet was administered orally in dose range of 3 to 12 milligram (mg) per day for 12 weeks as per Investigator's discretion.
|
|---|---|
|
Gastrointestinal disorders
Constipation
|
9.4%
46/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Dry Mouth
|
10.0%
49/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Infections and infestations
Nasopharyngitis
|
2.0%
10/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Muscle Rigidity
|
6.1%
30/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Akathisia
|
13.2%
65/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dizziness
|
2.6%
13/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dizziness Postural
|
4.9%
24/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Headache
|
9.2%
45/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Sedation
|
8.6%
42/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Somnolence
|
8.6%
42/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Tremor
|
7.1%
35/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Insomnia
|
19.8%
97/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Reproductive system and breast disorders
Amenorrhoea
|
4.3%
21/491 • Baseline up to Week 12
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
Additional Information
Senior Clinical Research Associate
Clinical Research Team, Medical Affairs Korea
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60