Trial Outcomes & Findings for Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants (NCT NCT00761605)
NCT ID: NCT00761605
Last Updated: 2014-09-10
Results Overview
The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
COMPLETED
PHASE4
387 participants
Baseline and Week 24
2014-09-10
Participant Flow
Participant milestones
| Measure |
Paliperidone
Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
|
|---|---|
|
Overall Study
STARTED
|
387
|
|
Overall Study
COMPLETED
|
246
|
|
Overall Study
NOT COMPLETED
|
141
|
Reasons for withdrawal
| Measure |
Paliperidone
Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
|
|---|---|
|
Overall Study
Adverse Event
|
26
|
|
Overall Study
Death
|
2
|
|
Overall Study
Lack of Efficacy
|
26
|
|
Overall Study
Lost to Follow-up
|
29
|
|
Overall Study
Withdrawal by Subject
|
37
|
|
Overall Study
Other
|
21
|
Baseline Characteristics
Phase 4 Study to Evaluate Efficacy of Paliperidone Extended-Release(ER) in Schizophrenic Participants
Baseline characteristics by cohort
| Measure |
Paliperidone
n=387 Participants
Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
|
|---|---|
|
Age, Continuous
|
36.73 years
STANDARD_DEVIATION 10.97 • n=99 Participants
|
|
Sex: Female, Male
Female
|
214 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 24Population: Intent to treat (ITT) population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies the participants evaluable for this measure.
The SCL90-R (Derogatis, 1992) measures 9 domains, including somatization, obsessive-compulsive, interpersonal sensitivity, depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism, which provides a global index of distress, the Global Severity Index (GSI). SCL-90-R includes 90 items rated on 5-point scale, ranging from 0 (not at all) to 4 (extremely). Total scale score range from 0 to 360. Higher scores indicate worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=78 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Baseline
|
99.84 Units on a scale
Standard Deviation 70.35
|
73.03 Units on a scale
Standard Deviation 57.60
|
67.66 Units on a scale
Standard Deviation 58.86
|
|
Change From Baseline in Symptom Checklist 90-R (SCL90-R) at Week 24
Change at Week 24
|
13.09 Units on a scale
Standard Deviation 57.78
|
8.87 Units on a scale
Standard Deviation 33.17
|
10.50 Units on a scale
Standard Deviation 42.33
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.
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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=78 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Baseline
|
56.03 Units on a scale
Standard Deviation 15.51
|
63.62 Units on a scale
Standard Deviation 11.76
|
63.44 Units on a scale
Standard Deviation 16.07
|
|
Change From Baseline in Total Personal and Social Performance (PSP) Score at Week 24
Change at Week 24
|
-5.81 Units on a scale
Standard Deviation 11.73
|
-3.77 Units on a scale
Standard Deviation 8.12
|
-4.59 Units on a scale
Standard Deviation 11.32
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
The SWN-20 scale is a 20 item scale that was originally designed to explore the subjective experience of psychotic participants. The SWN scale contains five sub-scales consisting of four items each: mental functioning (MF), self-control (SC), emotional regulation (ER), and social integration (SI), physical functioning (PF). The total score ranges from a minimum of 20 (poor subjective experience) to a maximum of 120 (excellent subjective experience). SWN scores appear to correlate with measure of objective psychopathology, quality of life and other self-ratings of mood. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=276 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=78 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Baseline
|
70.61 Units on a scale
Standard Deviation 17.09
|
76.67 Units on a scale
Standard Deviation 18.40
|
80.50 Units on a scale
Standard Deviation 17.01
|
|
Change From Baseline in Subjective Well-being Under Neuroleptic (SWN-20) Scale at Week 24
Change at Week 24
|
-1.54 Units on a scale
Standard Deviation 14.62
|
-2.33 Units on a scale
Standard Deviation 15.11
|
-1.06 Units on a scale
Standard Deviation 13.87
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
Sleep quality was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=77 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Baseline
|
65.62 Millimeter (mm)
Standard Deviation 30.52
|
70.89 Millimeter (mm)
Standard Deviation 24.90
|
62.45 Millimeter (mm)
Standard Deviation 30.96
|
|
Change From Baseline in Sleep Quality Based on Visual Analog Scale at Week 24
Change at Week 24
|
1.74 Millimeter (mm)
Standard Deviation 36.00
|
3.66 Millimeter (mm)
Standard Deviation 27.79
|
-1.94 Millimeter (mm)
Standard Deviation 34.18
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment."N" (number of participants analyzed) signifies participants evaluable for this measure.
Daytime Drowsiness was assessed by an 11-point visual analog scale. Participants indicated on the 11-point visual analog scale (score ranging from 0 to 100 millimeter) how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well); and how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time). Scores were averaged for the previous 7 days. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=77 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Baseline
|
43.27 Millimeter (mm)
Standard Deviation 31.65
|
39.40 Millimeter (mm)
Standard Deviation 28.02
|
44.47 Millimeter (mm)
Standard Deviation 28.12
|
|
Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale at Week 24
Change at Week 24
|
4.80 Millimeter (mm)
Standard Deviation 33.31
|
2.42 Millimeter (mm)
Standard Deviation 30.84
|
7.83 Millimeter (mm)
Standard Deviation 36.24
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population for efficacy included all the participants who received paliperidone ER at least once and who had at least 1 post baseline efficacy assessment.
Psychopathology of participants was assessed by Krawiecka scale. Psychopathology of participants was assessed by Krawiecka scale, score ranges from 0 to 16. Higher score indicates worsening of disease. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=78 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Krawiecka Scale Score at Week 24
Baseline
|
5.38 Units on a scale
Standard Deviation 3.28
|
4.74 Units on a scale
Standard Deviation 2.99
|
4.38 Units on a scale
Standard Deviation 3.02
|
|
Change From Baseline in Krawiecka Scale Score at Week 24
Change at Week 24
|
1.43 Units on a scale
Standard Deviation 2.62
|
1.32 Units on a scale
Standard Deviation 1.94
|
1.69 Units on a scale
Standard Deviation 2.72
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment.
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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=277 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=78 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=32 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
Baseline
|
3.77 Units on a scale
Standard Deviation 1.16
|
3.46 Units on a scale
Standard Deviation 0.98
|
3.25 Units on a scale
Standard Deviation 1.05
|
|
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 24
Change at Week 24
|
0.70 Units on a scale
Standard Deviation 1.04
|
0.47 Units on a scale
Standard Deviation 0.86
|
0.47 Units on a scale
Standard Deviation 0.95
|
SECONDARY outcome
Timeframe: Baseline and Week 24Population: The ITT population for efficacy included all the participants who received paliperidone extended-release (ER) at least once and who had at least 1 post baseline efficacy assessment. "N" (number of participants analyzed) signifies 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. Change from Baseline was calculated as value at Baseline minus value at Week 24. Data for three groups is presented here, based on participants' transition to Paliperidone ER from other oral antipsychotics.
Outcome measures
| Measure |
Paliperidone (Lack of Efficacy Group)
n=268 Participants
Paliperidone Extended-release (ER) tablet at a dose ranging from 3 to 12 milligram (mg) per day was given orally for 24 weeks as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy (switching of antipsychotic drug was clinically necessary because of no or insufficient response to treatment despite antipsychotic drug therapy at an adequate dose).
|
Paliperidone (Lack of Tolerability Group)
n=76 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability (switching of antipsychotic drug was necessary due to lack of tolerability or safety problem in the existing antipsychotic drug).
|
Paliperidone (Lack of Compliance Group)
n=31 Participants
Paliperidone ER tablet at a dose ranging from 3 to 12 mg per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of compliance (switching of antipsychotic drug was necessary due to lack of compliance in the existing antipsychotic drug).
|
|---|---|---|---|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
Baseline
|
3.63 Units on a scale
Standard Deviation 0.91
|
3.66 Units on a scale
Standard Deviation 0.60
|
3.48 Units on a scale
Standard Deviation 1.00
|
|
Change From Baseline in Clinical Global Impression - Improvement (CGI-I) Score at Week 24
Change at Week 24
|
0.46 Units on a scale
Standard Deviation 1.23
|
0.37 Units on a scale
Standard Deviation 0.96
|
0.35 Units on a scale
Standard Deviation 1.17
|
Adverse Events
Paliperidone
Serious adverse events
| Measure |
Paliperidone
n=387 participants at risk
Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Endocrine disorders
Hyperprolactinaemia
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Injury, poisoning and procedural complications
Overdose
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.26%
1/387 • Baseline up to Week 24
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)
Colon cancer stage IV
|
0.26%
1/387 • Baseline up to Week 24
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)
Metastases to liver
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Headache
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Syncope
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Acute psychosis
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Aggression
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Anxiety
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Completed suicide
|
1.3%
5/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Delusion
|
0.78%
3/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination
|
0.52%
2/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination, auditory
|
0.78%
3/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Insomnia
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Panic attack
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Psychiatric symptom
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Psychotic disorder
|
1.8%
7/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Schizophrenia
|
1.3%
5/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Suicide attempt
|
0.78%
3/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Surgical and medical procedures
Cholecystectomy
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Surgical and medical procedures
Gastrectomy
|
0.26%
1/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
Other adverse events
| Measure |
Paliperidone
n=387 participants at risk
Paliperidone oral tablet was administered once daily at a dose of 6 milligram (mg) for 24 weeks, wherein dose range was 3 to 12 mg per day.
|
|---|---|
|
Endocrine disorders
Hyperprolactinaemia
|
2.1%
8/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Eye disorders
Oculogyration
|
2.1%
8/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Constipation
|
3.4%
13/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Gastrointestinal disorders
Nausea
|
2.8%
11/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Infections and infestations
Nasopharyngitis
|
2.3%
9/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Investigations
Weight decreased
|
2.6%
10/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Investigations
Weight increased
|
9.3%
36/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
3.9%
15/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Akathisia
|
11.4%
44/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Bradykinesia
|
2.3%
9/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Dizziness
|
4.1%
16/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Extrapyramidal disorder
|
2.1%
8/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Headache
|
8.5%
33/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Sedation
|
2.6%
10/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Somnolence
|
5.2%
20/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Nervous system disorders
Tremor
|
5.9%
23/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Anxiety
|
5.7%
22/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Depression
|
2.8%
11/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Hallucination, auditory
|
2.1%
8/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Psychiatric disorders
Insomnia
|
12.4%
48/387 • Baseline up to Week 24
Safety population included all the eligible participants who received paliperidone extended-release (ER) at least once .
|
|
Reproductive system and breast disorders
Amenorrhoea
|
3.9%
15/387 • Baseline up to Week 24
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