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An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia

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ClinicalTrials.gov Identifier: NCT01299389
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : June 17, 2013
Last Update Posted : June 17, 2013
Sponsor:
Information provided by (Responsible Party):
Janssen Pharmaceutical K.K.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Schizophrenia
Interventions Drug: Paliperidone palmitate
Drug: Placebo
Enrollment 323
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Placebo (Post-observational) Paliperidone Palmitate (Post-observational)
Hide Arm/Group Description Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
Period Title: Double-blind
Started 164 159 0 0
Completed 55 95 0 0
Not Completed 109 64 0 0
Reason Not Completed
Adverse Event             45             27             0             0
Lack of Efficacy             45             21             0             0
Lost to Follow-up             2             1             0             0
Withdrawal by Subject             16             13             0             0
Other             1             1             0             0
fail to meet “study population” criteria             0             1             0             0
Period Title: Post-observational
Started 0 0 156 155
Completed 0 0 144 149
Not Completed 0 0 12 6
Reason Not Completed
Other             0             0             12             6
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Total
Hide Arm/Group Description Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period. Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period. Total of all reporting groups
Overall Number of Baseline Participants 164 159 323
Hide Baseline Analysis Population Description
Safety analysis set included all randomly assigned participants who received at least 1 injection of double-blind study drug.
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 164 participants 159 participants 323 participants
44.0  (12.41) 45.7  (13.55) 44.8  (12.99)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 164 participants 159 participants 323 participants
Female
81
  49.4%
58
  36.5%
139
  43.0%
Male
83
  50.6%
101
  63.5%
184
  57.0%
1.Primary Outcome
Title Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation
Hide Description The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210, higher scores indicate worsening.
Time Frame Baseline and Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set (FAS) population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. Last Observation Carried Forward (LOCF) method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularl (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 83.5  (15.18) 85.7  (14.57)
Change at Week 13 or Early Discontinuation 6.9  (19.13) -3.1  (20.32)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Change at Week 13 or Early Discontinuation: P value were calculated using an analysis of covariance (ANCOVA) model with treatment and country as factors and baseline PANSS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Least squares (LS) means difference
Estimated Value -9.7
Confidence Interval (2-Sided) 95%
-14.0 to -5.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.19
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation
Hide Description 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.
Time Frame Baseline and Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Median (Full Range)
Unit of Measure: units on a scale
Baseline
4.0
(2 to 7)
4.0
(2 to 6)
Change at Week 13 or Early Discontinuation
0.0
(-3 to 3)
0.0
(-3 to 3)
3.Secondary Outcome
Title Participants With Response to the Treatment as Per PANSS Total Score.
Hide Description Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.
Time Frame up to Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Measure Type: Number
Unit of Measure: participants
Greater than or equal to 30 percent Improvement 14 36
Greater than or equal to 20 percent Improvement 23 52
4.Secondary Outcome
Title Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation
Hide Description The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.
Time Frame Baseline and Week 13 or early discontinuation (ED)
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
Positive symptoms: Baseline 24.3  (5.56) 24.2  (5.66)
Positive symptoms: Change at Week 13 or ED 1.6  (6.06) -1.1  (6.29)
Negative symptoms: Baseline 21.7  (6.22) 22.8  (6.04)
Negative symptoms: Change at Week 13 or ED 0.9  (5.82) -1.4  (5.76)
Disorganized thoughts: Baseline 19.6  (5.13) 20.8  (4.83)
Disorganized thoughts: Change at Week 13 or ED 1.9  (5.24) -0.6  (5.11)
Uncontrolled hostility/excitement: Baseline 8.3  (3.07) 8.6  (3.42)
Uncontrolled hostility: Change at Week 13 or ED 1.9  (4.23) 0.4  (4.15)
Anxiety/depression: Baseline 9.5  (3.02) 9.4  (3.14)
Anxiety/depression: Change at Week 13 or ED 0.7  (3.27) -0.4  (3.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Positive symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.7
Confidence Interval (2-Sided) 95%
-4.1 to -1.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.69
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Negative symptoms (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0012
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.0
Confidence Interval (2-Sided) 95%
-3.2 to -0.8
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.61
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Disorganized thoughts (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-3.4 to -1.1
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.57
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Uncontrolled hostility/excitement (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0023
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.4
Confidence Interval (2-Sided) 95%
-2.3 to -0.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.45
Estimation Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Anxiety/depression (change at Week 13 or ED): P value was calculated using an ANCOVA model with treatment and country as factors and baseline PANSS factor scores as covariates.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0025
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -1.1
Confidence Interval (2-Sided) 95%
-1.9 to -0.4
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.37
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation
Hide Description Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.
Time Frame Baseline and Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 22.7  (6.19) 24.0  (5.77)
Change at Week 13 or Early Discontinuation 0.9  (5.54) -1.5  (5.38)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0003
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-3.3 to -1.0
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.59
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation
Hide Description Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.
Time Frame Baseline and Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 19.3  (4.97) 19.5  (5.47)
Change at Week 13 or Early Discontinuation 2.2  (5.82) -0.6  (6.19)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -2.8
Confidence Interval (2-Sided) 95%
-4.1 to -1.5
Parameter Dispersion
Type: Standard Error of the mean
Value: 0.67
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation
Hide Description General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.
Time Frame Baseline and Week 13 or early discontinuation
Hide Outcome Measure Data
Hide Analysis Population Description
FAS population included all randomly assigned participants who received at least 1 injection of double-blind study drug and had baseline and at least 1 post-baseline PANSS total scores. LOCF method was used.
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind)
Hide Arm/Group Description:
Matching Placebo was given intramuscularly on Day 1, Day 8, Day 36 and Day 64.
Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64.
Overall Number of Participants Analyzed 164 158
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline 41.4  (7.97) 42.3  (7.85)
Change at Week 13 or Early Discontinuation 3.8  (10.32) -1.0  (11.04)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Placebo (Double-blind), Paliperidone Palmitate (Double-blind)
Comments Change at Week 13 or Early Discontinuation: P value were calculated using an ANCOVA model with treatment and country as factors and baseline PANSS total score as a covariate.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter LS Mean difference
Estimated Value -4.6
Confidence Interval (2-Sided) 95%
-6.9 to -2.3
Parameter Dispersion
Type: Standard Error of the mean
Value: 1.17
Estimation Comments [Not Specified]
Time Frame From signing of the informed consent until study completion.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Placebo (Post-observational) Paliperidone Palmitate (Post-0bservational)
Hide Arm/Group Description Matching Placebo was given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Paliperidone palmitate was given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period. Participants who completed double-blind period or discontinued early from double-blind period had follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants did not receive any study drug during post-observational period.
All-Cause Mortality
Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Placebo (Post-observational) Paliperidone Palmitate (Post-0bservational)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Placebo (Post-observational) Paliperidone Palmitate (Post-0bservational)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   25/164 (15.24%)   10/159 (6.29%)   4/156 (2.56%)   6/155 (3.87%) 
Gastrointestinal disorders         
Gastritis * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hepatobiliary disorders         
Cholecystitis acute * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Injury, poisoning and procedural complications         
Ankle fracture * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Metabolism and nutrition disorders         
Dehydration * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hyponatraemia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Nervous system disorders         
Convulsion * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Epilepsy * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Loss of consciousness * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Akathisia * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Psychiatric disorders         
Psychiatric symptom * 1  13/164 (7.93%)  4/159 (2.52%)  2/156 (1.28%)  2/155 (1.29%) 
Schizophrenia * 1  3/164 (1.83%)  4/159 (2.52%)  2/156 (1.28%)  2/155 (1.29%) 
Suicide attempt * 1  2/164 (1.22%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Delusion * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hallucination, auditory * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Mental status changes * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Self injurious behaviour * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Reproductive system and breast disorders         
Ovarian cyst torsion * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Placebo (Double-blind) Paliperidone Palmitate (Double-blind) Placebo (Post-observational) Paliperidone Palmitate (Post-0bservational)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   131/164 (79.88%)   133/159 (83.65%)   94/156 (60.26%)   79/155 (50.97%) 
Blood and lymphatic system disorders         
Anaemia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Leukopenia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Thrombocytopenia * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Leukocytosis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Cardiac disorders         
Bradycardia * 1  3/164 (1.83%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Palpitations * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Tachycardia * 1  2/164 (1.22%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Atrial fibrillation * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Sinus bradycardia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Ventricular extrasystoles * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Left ventricular hypertrophy * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Diastolic dysfunction * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Ear and labyrinth disorders         
Vertigo * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Auricular swelling * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Tinnitus * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Ear pain * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Eye disorders         
Asthenopia * 1  0/164 (0.00%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Eye discharge * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Eye pain * 1  0/164 (0.00%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Eyelid oedema * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Oculogyric crisis * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Ocular discomfort * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Vision blurred * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Conjunctivitis * 1  1/164 (0.61%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Conjunctivitis allergic * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Dry eye * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Gastrointestinal disorders         
Constipation * 1  9/164 (5.49%)  9/159 (5.66%)  13/156 (8.33%)  8/155 (5.16%) 
Diarrhoea * 1  6/164 (3.66%)  5/159 (3.14%)  4/156 (2.56%)  3/155 (1.94%) 
Toothache * 1  4/164 (2.44%)  5/159 (3.14%)  4/156 (2.56%)  3/155 (1.94%) 
Abdominal discomfort * 1  5/164 (3.05%)  2/159 (1.26%)  4/156 (2.56%)  2/155 (1.29%) 
Abdominal pain upper * 1  1/164 (0.61%)  2/159 (1.26%)  5/156 (3.21%)  1/155 (0.65%) 
Nausea * 1  8/164 (4.88%)  6/159 (3.77%)  4/156 (2.56%)  1/155 (0.65%) 
Dry mouth * 1  1/164 (0.61%)  1/159 (0.63%)  3/156 (1.92%)  1/155 (0.65%) 
Dyspepsia * 1  3/164 (1.83%)  3/159 (1.89%)  2/156 (1.28%)  1/155 (0.65%) 
Abdominal pain * 1  1/164 (0.61%)  1/159 (0.63%)  2/156 (1.28%)  0/155 (0.00%) 
Dental caries * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  2/155 (1.29%) 
Gastrooesophageal reflux disease * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Vomiting * 1  3/164 (1.83%)  8/159 (5.03%)  2/156 (1.28%)  0/155 (0.00%) 
Abdominal pain lower * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Dysphagia * 1  0/164 (0.00%)  3/159 (1.89%)  1/156 (0.64%)  0/155 (0.00%) 
Gastritis * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Gastritis atrophic * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Gingival bleeding * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Gingivitis * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Ileus * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Mouth ulceration * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Tongue discolouration * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Lip haemorrhage * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Anal haemorrhage * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Tongue haemorrhage * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Gastrointestinal disorder * 1  3/164 (1.83%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Abdominal distension * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Defaecation urgency * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Haemorrhoids * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Periodontitis * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Stomatitis * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Epigastric discomfort * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
General disorders         
Chest pain * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Feeling abnormal * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hunger * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Pyrexia * 1  3/164 (1.83%)  1/159 (0.63%)  4/156 (2.56%)  1/155 (0.65%) 
Malaise * 1  0/164 (0.00%)  1/159 (0.63%)  2/156 (1.28%)  1/155 (0.65%) 
Asthenia * 1  2/164 (1.22%)  0/159 (0.00%)  0/156 (0.00%)  2/155 (1.29%) 
Fatigue * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Feeling cold * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Injection site pain * 1  11/164 (6.71%)  21/159 (13.21%)  1/156 (0.64%)  0/155 (0.00%) 
Irritability * 1  2/164 (1.22%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Oedema * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Oedema peripheral * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Pain * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Injection site induration * 1  4/164 (2.44%)  6/159 (3.77%)  0/156 (0.00%)  0/155 (0.00%) 
Chest discomfort * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Injection site swelling * 1  0/164 (0.00%)  4/159 (2.52%)  0/156 (0.00%)  0/155 (0.00%) 
Gait disturbance * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Injection site haematoma * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Injection site warmth * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Vessel puncture site swelling * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hepatobiliary disorders         
Liver injury * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hepatitis toxic * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Hepatic function abnormal * 1  1/164 (0.61%)  5/159 (3.14%)  0/156 (0.00%)  0/155 (0.00%) 
Immune system disorders         
Hypersensitivity * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Infections and infestations         
Nasopharyngitis * 1  10/164 (6.10%)  20/159 (12.58%)  13/156 (8.33%)  13/155 (8.39%) 
Upper respiratory tract infection * 1  7/164 (4.27%)  8/159 (5.03%)  4/156 (2.56%)  6/155 (3.87%) 
Cystitis * 1  0/164 (0.00%)  2/159 (1.26%)  0/156 (0.00%)  1/155 (0.65%) 
Hordeolum * 1  2/164 (1.22%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Tinea pedis * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Urinary tract infection * 1  1/164 (0.61%)  1/159 (0.63%)  3/156 (1.92%)  1/155 (0.65%) 
Adenoviral conjunctivitis * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Rhinitis * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Vaginal infection * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Bronchitis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Influenza * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Pharyngitis * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  2/155 (1.29%) 
Tinea infection * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Acute tonsillitis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Carbuncle * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Cellulitis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Furuncle * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Gastroenteritis * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Herpes zoster * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Impetigo * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Paronychia * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Helicobacter infection * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Acarodermatitis * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Injury, poisoning and procedural complications         
Periorbital haematoma * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Tendon rupture * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Thermal burn * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Anal injury * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Contusion * 1  3/164 (1.83%)  0/159 (0.00%)  2/156 (1.28%)  2/155 (1.29%) 
Excoriation * 1  4/164 (2.44%)  1/159 (0.63%)  1/156 (0.64%)  2/155 (1.29%) 
Fall * 1  1/164 (0.61%)  1/159 (0.63%)  2/156 (1.28%)  0/155 (0.00%) 
Arthropod sting * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Chillblains * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Fracture * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Laceration * 1  3/164 (1.83%)  2/159 (1.26%)  0/156 (0.00%)  1/155 (0.65%) 
Scratch * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Superficial injury of eye * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Wound * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Lip injury * 1  1/164 (0.61%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Tooth fracture * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Head injury * 1  2/164 (1.22%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Ligament sprain * 1  0/164 (0.00%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Subcutaneous haematoma * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Investigations         
Weight decreased * 1  7/164 (4.27%)  3/159 (1.89%)  1/156 (0.64%)  1/155 (0.65%) 
Weight increased * 1  0/164 (0.00%)  7/159 (4.40%)  1/156 (0.64%)  0/155 (0.00%) 
Blood urine present * 1  2/164 (1.22%)  3/159 (1.89%)  0/156 (0.00%)  0/155 (0.00%) 
Alanine aminotransferase increased * 1  1/164 (0.61%)  3/159 (1.89%)  0/156 (0.00%)  0/155 (0.00%) 
Blood glucose increased * 1  2/164 (1.22%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Blood cholesterol increased * 1  2/164 (1.22%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Aspartate aminotransferase increased * 1  0/164 (0.00%)  2/159 (1.26%)  1/156 (0.64%)  0/155 (0.00%) 
Blood pressure increased * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood triglycerides increased * 1  2/164 (1.22%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Blood urea increased * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Electrocardiogram QT prolonged * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Gamma-glutamyltransferase increased * 1  0/164 (0.00%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Liver function test abnormal * 1  1/164 (0.61%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Low density lipoprotein increased * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood creatine phosphokinase increased * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Blood prolactin increased * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Blood lactate dehydrogenase increased * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Blood potassium increased * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Platelet count decreased * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Red blood cell count decreased * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Hepatic enzyme abnormal * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Influenza A virus test positive * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Protein urine present * 1  0/164 (0.00%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Urobilinogen urine increased * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood bicarbonate decreased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Blood bilirubin increased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Blood chloride increased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Blood creatinine increased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood pressure decreased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood sodium decreased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Glucose urine present * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Glycosylated haemoglobin increased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Neutrophil count increased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
White blood cell count decreased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
White blood cell count increased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Blood phosphorus decreased * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Lymphocyte percentage decreased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite * 1  6/164 (3.66%)  5/159 (3.14%)  0/156 (0.00%)  2/155 (1.29%) 
Hyperlipidaemia * 1  2/164 (1.22%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Hyperglycaemia * 1  0/164 (0.00%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Hypokalaemia * 1  1/164 (0.61%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Dehydration * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Diet refusal * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hyperphagia * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hyperuricaemia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hypertriglyceridaemia * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Increased appetite * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Polydipsia * 1  0/164 (0.00%)  3/159 (1.89%)  1/156 (0.64%)  0/155 (0.00%) 
Weight fluctuation * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  2/164 (1.22%)  1/159 (0.63%)  2/156 (1.28%)  3/155 (1.94%) 
Pain in extremity * 1  1/164 (0.61%)  2/159 (1.26%)  2/156 (1.28%)  2/155 (1.29%) 
Back pain * 1  1/164 (0.61%)  1/159 (0.63%)  3/156 (1.92%)  1/155 (0.65%) 
Myalgia * 1  2/164 (1.22%)  0/159 (0.00%)  2/156 (1.28%)  1/155 (0.65%) 
Gouty arthritis * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Muscle rigidity * 1  0/164 (0.00%)  1/159 (0.63%)  2/156 (1.28%)  0/155 (0.00%) 
Flank pain * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Groin pain * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Musculoskeletal pain * 1  0/164 (0.00%)  1/159 (0.63%)  1/156 (0.64%)  0/155 (0.00%) 
Neck pain * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Osteoarthritis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Spinal osteoarthritis * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Musculoskeletal chest pain * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Musculoskeletal stiffness * 1  2/164 (1.22%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Torticollis * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Joint range of motion decreased * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Muscle fatigue * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Nuchal rigidity * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Skin papilloma * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Lipoma * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Nervous system disorders         
Extrapyramidal disorder * 1  8/164 (4.88%)  16/159 (10.06%)  6/156 (3.85%)  1/155 (0.65%) 
Headache * 1  6/164 (3.66%)  8/159 (5.03%)  5/156 (3.21%)  4/155 (2.58%) 
Akathisia * 1  3/164 (1.83%)  8/159 (5.03%)  11/156 (7.05%)  5/155 (3.23%) 
Dizziness * 1  5/164 (3.05%)  1/159 (0.63%)  4/156 (2.56%)  1/155 (0.65%) 
Tremor * 1  2/164 (1.22%)  4/159 (2.52%)  2/156 (1.28%)  3/155 (1.94%) 
Dystonia * 1  1/164 (0.61%)  4/159 (2.52%)  2/156 (1.28%)  0/155 (0.00%) 
Parkinsonism * 1  3/164 (1.83%)  1/159 (0.63%)  5/156 (3.21%)  1/155 (0.65%) 
Sedation * 1  0/164 (0.00%)  3/159 (1.89%)  0/156 (0.00%)  1/155 (0.65%) 
Hypoaesthesia * 1  0/164 (0.00%)  2/159 (1.26%)  1/156 (0.64%)  0/155 (0.00%) 
Somnolence * 1  0/164 (0.00%)  2/159 (1.26%)  1/156 (0.64%)  4/155 (2.58%) 
Bradykinesia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Disturbance in attention * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Drooling * 1  0/164 (0.00%)  1/159 (0.63%)  3/156 (1.92%)  2/155 (1.29%) 
Dyskinesia * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hypersomnia * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Psychomotor hyperactivity * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Sleep phase rhythm disturbance * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Syncope * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Cognitive disorder * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Intracranial haematoma * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Head titubation * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Thermohyperaesthesia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Dysarthria * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Convulsion * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Essential tremor * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Poor quality sleep * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Tardive dyskinesia * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Dysstasia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Psychiatric disorders         
Insomnia * 1  25/164 (15.24%)  27/159 (16.98%)  6/156 (3.85%)  6/155 (3.87%) 
Psychiatric symptom * 1  33/164 (20.12%)  14/159 (8.81%)  4/156 (2.56%)  2/155 (1.29%) 
Anxiety * 1  13/164 (7.93%)  10/159 (6.29%)  5/156 (3.21%)  1/155 (0.65%) 
Aggression * 1  1/164 (0.61%)  4/159 (2.52%)  0/156 (0.00%)  1/155 (0.65%) 
Agitation * 1  4/164 (2.44%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hallucination, auditory * 1  2/164 (1.22%)  2/159 (1.26%)  1/156 (0.64%)  0/155 (0.00%) 
Delusion * 1  1/164 (0.61%)  2/159 (1.26%)  0/156 (0.00%)  1/155 (0.65%) 
Persecutory delusion * 1  2/164 (1.22%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Psychotic disorder * 1  1/164 (0.61%)  2/159 (1.26%)  0/156 (0.00%)  0/155 (0.00%) 
Hallucination * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Sleep disorder * 1  2/164 (1.22%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Self injurious behaviour * 1  2/164 (1.22%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Anger * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Catatonia * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Depression * 1  0/164 (0.00%)  1/159 (0.63%)  1/156 (0.64%)  2/155 (1.29%) 
Emotional disorder * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hostility * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Inappropriate affect * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Initial insomnia * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Obsessive thoughts * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Restlessness * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Soliloquy * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Somatic delusion * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Impulse-control disorder * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Middle insomnia * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Schizophrenia * 1  7/164 (4.27%)  2/159 (1.26%)  1/156 (0.64%)  1/155 (0.65%) 
Intentional self-injury * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Suicidal ideation * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Thinking abnormal * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Self-injurious ideation * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Burnout syndrome * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Abnormal behaviour * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Disorientation * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Renal and urinary disorders         
Dysuria * 1  1/164 (0.61%)  0/159 (0.00%)  3/156 (1.92%)  1/155 (0.65%) 
Urinary retention * 1  1/164 (0.61%)  1/159 (0.63%)  2/156 (1.28%)  0/155 (0.00%) 
Micturition disorder * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Renal failure chronic * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Urge incontinence * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Urinary incontinence * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Stress urinary incontinence * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Glycosuria * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Pollakiuria * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Proteinuria * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Reproductive system and breast disorders         
Dysmenorrhoea * 1  0/164 (0.00%)  0/159 (0.00%)  3/156 (1.92%)  0/155 (0.00%) 
Ejaculation disorder * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Menstruation irregular * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Pruritus genital * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Menorrhagia * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Nipple pain * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough * 1  1/164 (0.61%)  4/159 (2.52%)  1/156 (0.64%)  0/155 (0.00%) 
Dyspnoea * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Nasal obstruction * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Productive cough * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Oropharyngeal pain * 1  1/164 (0.61%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Upper respiratory tract inflammation * 1  3/164 (1.83%)  0/159 (0.00%)  1/156 (0.64%)  2/155 (1.29%) 
Nasal congestion * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  1/155 (0.65%) 
Rhinorrhoea * 1  0/164 (0.00%)  0/159 (0.00%)  2/156 (1.28%)  0/155 (0.00%) 
Bronchitis chronic * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Pneumonia aspiration * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Rhinitis allergic * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Rhinitis seasonal * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Oropharyngeal discomfort * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Skin and subcutaneous tissue disorders         
Eczema * 1  3/164 (1.83%)  4/159 (2.52%)  0/156 (0.00%)  2/155 (1.29%) 
Pruritus * 1  4/164 (2.44%)  3/159 (1.89%)  0/156 (0.00%)  4/155 (2.58%) 
Rash * 1  2/164 (1.22%)  3/159 (1.89%)  1/156 (0.64%)  3/155 (1.94%) 
Acne * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Dermatitis * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Dermatitis atopic * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Hyperkeratosis * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  1/155 (0.65%) 
Skin chapped * 1  2/164 (1.22%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Dermatitis contact * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Eczema nummular * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Erythema * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Haemorrhage subcutaneous * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Rash pruritic * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Skin lesion * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Nail bed inflammation * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Seborrhoeic dermatitis * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  2/155 (1.29%) 
Dry skin * 1  0/164 (0.00%)  0/159 (0.00%)  1/156 (0.64%)  0/155 (0.00%) 
Swelling face * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Surgical and medical procedures         
Tooth extraction * 1  0/164 (0.00%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Vascular disorders         
Hypertension * 1  2/164 (1.22%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Orthostatic hypotension * 1  1/164 (0.61%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
Haematoma * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Hypotension * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  1/155 (0.65%) 
Labile blood pressure * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Vasculitis * 1  1/164 (0.61%)  0/159 (0.00%)  0/156 (0.00%)  0/155 (0.00%) 
Haemorrhage * 1  0/164 (0.00%)  1/159 (0.63%)  0/156 (0.00%)  0/155 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 14.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Medical director
Organization: Janssen Pharmaceutical K.K
Phone: +81-3-4411-5509
Responsible Party: Janssen Pharmaceutical K.K.
ClinicalTrials.gov Identifier: NCT01299389     History of Changes
Other Study ID Numbers: CR017026
PALM-JPN-4 ( Other Identifier: Janssen Pharmaceutical K.K., Japan )
First Submitted: January 27, 2011
First Posted: February 18, 2011
Results First Submitted: March 4, 2013
Results First Posted: June 17, 2013
Last Update Posted: June 17, 2013