{ "FullStudy":{ "Rank":217896, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515423", "OrgStudyIdInfo":{ "OrgStudyId":"CR100662" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"R092670PSY3011", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Janssen Research & Development, LLC" },{ "SecondaryId":"2011-004889-15", "SecondaryIdType":"EudraCT Number" },{ "SecondaryId":"U1111-1135-7054", "SecondaryIdType":"Other Identifier", "SecondaryIdDomain":"Universal Trial Number" } ] }, "Organization":{ "OrgFullName":"Janssen Research & Development, LLC", "OrgClass":"INDUSTRY" }, "BriefTitle":"Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia", "OfficialTitle":"A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia" }, "StatusModule":{ "StatusVerifiedDate":"April 2016", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"February 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2015", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 17, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"February 1, 2016", "ResultsFirstSubmitQCDate":"April 28, 2016", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"May 2, 2016", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"April 28, 2016", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"May 2, 2016", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Janssen Research & Development, LLC", "LeadSponsorClass":"INDUSTRY" } }, "OversightModule":{ "OversightHasDMC":"No" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.", "DetailedDescription":"This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Schizophrenia" ] }, "KeywordList":{ "Keyword":[ "Schizophrenia", "R092670", "Paliperidone Palmitate", "Paliperidone palmitate 1 month formulation (PP1M)", "Paliperidone palmitate 3 month formulation (PP3M)" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 3" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Double", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"1429", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Paliperidone palmitate 3-month (PP3M)", "ArmGroupType":"Experimental", "ArmGroupDescription":"A formulation of paliperidone palmitate with a 3-month injection interval", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PP3M 175 mg eq.", "Drug: PP3M 263 mg eq.", "Drug: PP3M 350 mg eq.", "Drug: PP3M 525 mg eq.", "Drug: Placebo (20% Intralipid)" ] } },{ "ArmGroupLabel":"Paliperidone palmitate 1-month (PP1M)", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"A formulation of paliperidone palmitate with a 1-month injection interval", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: PP1M 50 mg eq.", "Drug: PP1M 75 mg eq.", "Drug: PP1M 100 mg eq.", "Drug: PP1M 150 mg eq." ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"PP3M 175 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every third month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 3-month (PP3M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP3M 263 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every third month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 3-month (PP3M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP3M 350 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every third month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 3-month (PP3M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP3M 525 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every third month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 3-month (PP3M)" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo (20% Intralipid)", "InterventionDescription":"Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 3-month (PP3M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP1M 50 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 1-month (PP1M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP1M 75 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 1-month (PP1M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP1M 100 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 1-month (PP1M)" ] } },{ "InterventionType":"Drug", "InterventionName":"PP1M 150 mg eq.", "InterventionDescription":"Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Paliperidone palmitate 1-month (PP1M)" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase", "PrimaryOutcomeDescription":"Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.", "PrimaryOutcomeTimeFrame":"Up to 48 weeks" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48", "SecondaryOutcomeDescription":"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).", "SecondaryOutcomeTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint" },{ "SecondaryOutcomeMeasure":"Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48", "SecondaryOutcomeDescription":"The Clinical Global Impression Severity (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.", "SecondaryOutcomeTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint" },{ "SecondaryOutcomeMeasure":"Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48", "SecondaryOutcomeDescription":"The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.", "SecondaryOutcomeTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint" },{ "SecondaryOutcomeMeasure":"Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria", "SecondaryOutcomeDescription":"Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.", "SecondaryOutcomeTimeFrame":"Weeks 41 to 65" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48", "SecondaryOutcomeDescription":"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).", "SecondaryOutcomeTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint" },{ "SecondaryOutcomeMeasure":"Change From Baseline in Marder Factor Subscale Score at Week 48", "SecondaryOutcomeDescription":"5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.", "SecondaryOutcomeTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator\nA total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 120\nSigned informed consent\nWomen must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control\nMen must agree to use a double-barrier method of birth control\nBe medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG)\n\nExclusion Criteria:\n\nA diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis\nRelevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)\nA diagnosis of substance dependence within 6 months before screening\nHistory of neuroleptic malignant syndrome (NMS) or tardive dyskinesia\nClozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness\nClinically significant findings in biochemistry, hematology, ECG or urinalysis results\nAny other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments", 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Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. eCollection 2020." },{ "ReferencePMID":"30994855", "ReferenceType":"derived", "ReferenceCitation":"Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153." },{ "ReferencePMID":"30962688", "ReferenceType":"derived", "ReferenceCitation":"Nash AI, Turkoz I, Savitz AJ, Mathews M, Kim E. Predictors of achieving remission in schizophrenia patients treated with paliperidone palmitate 3-month formulation. Neuropsychiatr Dis Treat. 2019 Mar 22;15:731-737. doi: 10.2147/NDT.S194264. eCollection 2019." },{ "ReferencePMID":"29882073", "ReferenceType":"derived", "ReferenceCitation":"Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z." },{ "ReferencePMID":"27743205", "ReferenceType":"derived", "ReferenceCitation":"Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3." },{ "ReferencePMID":"27333588", "ReferenceType":"derived", "ReferenceCitation":"Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24." } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"1429 participants received at least 1 dose of the study agent in the Open-label Phase, out of which 1016 participants were randomized into the Double blind Phase (Safety population).", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation", "FlowGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9." },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation", "FlowGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "FlowGroupId":"FG002", "FlowGroupTitle":"Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation", "FlowGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Open Label Phase", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1429" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"1016" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"413" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"0" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"57" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lack of Efficacy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"117" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"21" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"118" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"excluded from DB Phase", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"70" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"28" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } },{ "FlowPeriodTitle":"DOUBLE BLIND", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"504" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"512" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"422" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"420" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"82" },{ "FlowAchievementGroupId":"FG002", "FlowAchievementNumSubjects":"92" } ] } } ] }, "FlowDropWithdrawList":{ "FlowDropWithdraw":[ { "FlowDropWithdrawType":"Adverse Event", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"15" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"13" } ] } },{ "FlowDropWithdrawType":"Death", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"2" } ] } },{ "FlowDropWithdrawType":"Lost to Follow-up", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"7" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"12" } ] } },{ "FlowDropWithdrawType":"Pregnancy", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"2" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } },{ "FlowDropWithdrawType":"Withdrawal by Subject", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"50" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"53" } ] } },{ "FlowDropWithdrawType":"Other", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"6" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"12" } ] } },{ "FlowDropWithdrawType":"Blind broken by investigator", "FlowReasonList":{ "FlowReason":[ { "FlowReasonGroupId":"FG000", "FlowReasonNumSubjects":"0" },{ "FlowReasonGroupId":"FG001", "FlowReasonNumSubjects":"1" },{ "FlowReasonGroupId":"FG002", "FlowReasonNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselinePopulationDescription":"The safety analysis set included all participants who were randomly assigned to treatment during the Double-blind Phase and received at least 1 dose study drug.", "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation", "BaselineGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation", "BaselineGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"504" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"512" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"1016" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"39.0", "BaselineMeasurementSpread":"11.89" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"38.3", "BaselineMeasurementSpread":"12.24" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"38.6", "BaselineMeasurementSpread":"12.06" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"246" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"231" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"477" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"258" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"281" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"539" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"China", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"104" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"106" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"210" } ] } } ] } },{ "BaselineClassTitle":"Russian Federation", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"75" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"150" } ] } } ] } },{ "BaselineClassTitle":"Japan", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"52" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"56" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"108" } ] } } ] } },{ "BaselineClassTitle":"United States", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"41" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"48" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"89" } ] } } ] } },{ "BaselineClassTitle":"Ukraine", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"35" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"64" } ] } } ] } },{ "BaselineClassTitle":"Czech Republic", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"60" } ] } } ] } },{ "BaselineClassTitle":"Hungary", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"21" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"19" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"40" } ] } } ] } },{ "BaselineClassTitle":"Poland", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"37" } ] } } ] } },{ "BaselineClassTitle":"Argentina", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"30" } ] } } ] } },{ "BaselineClassTitle":"Bulgaria", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"16" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"28" } ] } } ] } },{ "BaselineClassTitle":"Brazil", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"13" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"25" } ] } } ] } },{ "BaselineClassTitle":"Spain", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"14" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"25" } ] } } ] } },{ "BaselineClassTitle":"Slovakia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"22" } ] } } ] } },{ "BaselineClassTitle":"Portugal", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"11" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"10" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"21" } ] } } ] } },{ "BaselineClassTitle":"Mexico", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"9" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"16" } ] } } ] } },{ "BaselineClassTitle":"Taiwan", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"14" } ] } } ] } },{ "BaselineClassTitle":"Romania", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" } ] } } ] } },{ "BaselineClassTitle":"Germany", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"South Korea", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"12" } ] } } ] } },{ "BaselineClassTitle":"Belgium", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"11" } ] } } ] } },{ "BaselineClassTitle":"Greece", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"5" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"11" } ] } } ] } },{ "BaselineClassTitle":"Canada", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"9" } ] } } ] } },{ "BaselineClassTitle":"Australia", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"3" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"5" } ] } } ] } },{ "BaselineClassTitle":"France", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"3" } ] } } ] } },{ "BaselineClassTitle":"Austria", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase", "OutcomeMeasureDescription":"Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.", "OutcomeMeasurePopulationDescription":"Modified intent-to-treat (mITT) analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Up to 48 weeks", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"458" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"490" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"91.5" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"90.0" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48", "OutcomeMeasureDescription":"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"481" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"503" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"57.4", "OutcomeMeasurementSpread":"8.56" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"58.1", "OutcomeMeasurementSpread":"8.88" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at DB End point", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-3.5", "OutcomeMeasurementSpread":"12.50" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-4.3", "OutcomeMeasurementSpread":"11.78" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48", "OutcomeMeasureDescription":"The Clinical Global Impression Severity (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.", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"481" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"504" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"2.9", "OutcomeMeasurementSpread":"0.57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"2.9", "OutcomeMeasurementSpread":"0.66" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at DB End point", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.1", "OutcomeMeasurementSpread":"0.84" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.1", "OutcomeMeasurementSpread":"0.75" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48", "OutcomeMeasureDescription":"The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"474" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"495" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"65.5", "OutcomeMeasurementSpread":"10.40" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"65.0", "OutcomeMeasurementSpread":"11.06" } ] } } ] } },{ "OutcomeClassTitle":"Change from Baseline at DB End point", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"1.3", "OutcomeMeasurementSpread":"10.22" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"1.9", "OutcomeMeasurementSpread":"9.21" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria", "OutcomeMeasureDescription":"Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"Percentage of Participants", "OutcomeMeasureTimeFrame":"Weeks 41 to 65", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"483" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"512" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"58.4", "OutcomeMeasurementLowerLimit":"0.89", "OutcomeMeasurementUpperLimit":"1.08" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"59.2", "OutcomeMeasurementLowerLimit":"0.89", "OutcomeMeasurementUpperLimit":"1.08" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48", "OutcomeMeasureDescription":"The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"483" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"512" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Positive subscale: Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"11.9", "OutcomeMeasurementSpread":"3.12" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"12.0", "OutcomeMeasurementSpread":"3.19" } ] } } ] } },{ "OutcomeClassTitle":"Positive subscale:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.6", "OutcomeMeasurementSpread":"4.31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.9", "OutcomeMeasurementSpread":"3.70" } ] } } ] } },{ "OutcomeClassTitle":"Negative subscale: Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"17.3", "OutcomeMeasurementSpread":"4.27" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"17.3", "OutcomeMeasurementSpread":"4.11" } ] } } ] } },{ "OutcomeClassTitle":"Negative subscale:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.4", "OutcomeMeasurementSpread":"3.63" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.4", "OutcomeMeasurementSpread":"3.67" } ] } } ] } },{ "OutcomeClassTitle":"General psychopathology : Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"28.2", "OutcomeMeasurementSpread":"4.55" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28.8", "OutcomeMeasurementSpread":"4.79" } ] } } ] } },{ "OutcomeClassTitle":"General psychopathology : Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.4", "OutcomeMeasurementSpread":"6.77" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-2.0", "OutcomeMeasurementSpread":"6.57" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Change From Baseline in Marder Factor Subscale Score at Week 48", "OutcomeMeasureDescription":"5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.", "OutcomeMeasurePopulationDescription":"mITT analysis set included all participants who were randomly assigned to treatment during Double-blind Phase, received at least 1 dose of study drug and did not have any errors in the delivery of active treatment. Here,N=number of participants analysed is the total participants who were evaluable for this outcome measure.", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"Units on a scale", "OutcomeMeasureTimeFrame":"DB Baseline (Week 17) and 48 week or DB Endpoint", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 3 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle." },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Double Blind: Paliperidone Palmitate 1 Month Formulation", "OutcomeGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle." } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"483" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"512" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeClassTitle":"Positive symptoms factor: Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"15.7", "OutcomeMeasurementSpread":"3.66" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"15.8", "OutcomeMeasurementSpread":"3.88" } ] } } ] } },{ "OutcomeClassTitle":"Positive symptoms factor:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.1", "OutcomeMeasurementSpread":"4.61" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.4", "OutcomeMeasurementSpread":"4.16" } ] } } ] } },{ "OutcomeClassTitle":"Negative symptoms factor: Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"16.2", "OutcomeMeasurementSpread":"4.03" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"16.3", "OutcomeMeasurementSpread":"3.90" } ] } } ] } },{ "OutcomeClassTitle":"Negative symptoms factor : Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.4", "OutcomeMeasurementSpread":"3.57" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.3", "OutcomeMeasurementSpread":"3.80" } ] } } ] } },{ "OutcomeClassTitle":"Disorganized thoughts factor :Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"14.2", "OutcomeMeasurementSpread":"3.20" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"14.3", "OutcomeMeasurementSpread":"3.17" } ] } } ] } },{ "OutcomeClassTitle":"Disorganized thoughts factor:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-1.2", "OutcomeMeasurementSpread":"3.36" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-1.2", "OutcomeMeasurementSpread":"3.24" } ] } } ] } },{ "OutcomeClassTitle":"Uncontrolled hostility Factor:Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"5.2", "OutcomeMeasurementSpread":"1.64" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"5.4", "OutcomeMeasurementSpread":"1.77" } ] } } ] } },{ "OutcomeClassTitle":"Uncontrolled hostility Factor:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"0.2", "OutcomeMeasurementSpread":"2.31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.2", "OutcomeMeasurementSpread":"2.21" } ] } } ] } },{ "OutcomeClassTitle":"Anxiety/depression factor:Baseline", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"6.1", "OutcomeMeasurementSpread":"2.02" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"6.3", "OutcomeMeasurementSpread":"2.12" } ] } } ] } },{ "OutcomeClassTitle":"Anxiety/depression factor:Change at Endpoint", "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"-0.0", "OutcomeMeasurementSpread":"2.69" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"-0.2", "OutcomeMeasurementSpread":"2.43" } ] } } ] } } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"2", "EventsTimeFrame":"From signing of informed consent form up to Follow-Up Visit (4 or 12 Weeks after study drug administration)", "EventsDescription":"For Double-blind (DB) phase, safety analysis set included all participants who were randomly assigned to treatment during DB Phase and received at least 1 dose of DB study drug. For Open-label Phase, all participants who received at least 1 dose of open-label study drug and were included in summary of safety assessments for that phase.", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Open-Label: Paliperidone Palmitate (PP1M) 1-month Formulation", "EventGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a dose of 150 milligram equivalent (mg eq.) on Day 1 and 100 mg eq. on Day 8, both as an injection in the deltoid muscle. The injections at Week 5 (Day 36) and Week 9 (Day 64) given in either the deltoid or gluteal muscle and were flexibly dosed (50, 75, 100, or 150 mg eq.). At Week 13 (Day 92) participants received the same dose of PP1M that was administered at Week 9.", "EventGroupSeriousNumAffected":"101", "EventGroupSeriousNumAtRisk":"1429", "EventGroupOtherNumAffected":"457", "EventGroupOtherNumAtRisk":"1429" },{ "EventGroupId":"EG001", "EventGroupTitle":"Double-Blind: Paliperidone Palmitate(PP3M) 3-month Formulation", "EventGroupDescription":"Participants received Paliperidone Palmitate 3-month formulation (PP3M) in a fixed dose of 3.5 fold multiple of the PP1M dose administered at Week 13, that is participants received fixed dose injections of PP3M (175, 263, 350, or 525 mg eq.) on Week 17, 29, 41, and 53 as injection in deltoid muscle or gluteal muscle.", "EventGroupSeriousNumAffected":"26", "EventGroupSeriousNumAtRisk":"504", "EventGroupOtherNumAffected":"212", "EventGroupOtherNumAtRisk":"504" },{ "EventGroupId":"EG002", "EventGroupTitle":"Double-Blind: Paliperidone Palmitate(PP1M) 1-month Formulation", "EventGroupDescription":"Participants received Paliperidone Palmitate 1-month formulation (PP1M) in a fixed dose that was administered at Week 9 at every month for 48 weeks, that is, participants received fixed dose injections of PP1M (50, 75, 100, or 150 mg eq.) as injection on deltoid muscle or gluteal muscle.", "EventGroupSeriousNumAffected":"37", "EventGroupSeriousNumAtRisk":"512", "EventGroupOtherNumAffected":"208", "EventGroupOtherNumAtRisk":"512" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"Pancytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"504" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"512" } ] } },{ "SeriousEventTerm":"Thrombocytopenia", "SeriousEventOrganSystem":"Blood and lymphatic system disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"504" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"512" } ] } },{ "SeriousEventTerm":"Cardiac Arrest", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"504" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"512" } ] } },{ "SeriousEventTerm":"Vertigo", "SeriousEventOrganSystem":"Ear and labyrinth disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"504" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"512" } ] } },{ "SeriousEventTerm":"Gastrointestinal Disorder", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"504" },{ "SeriousEventStatsGroupId":"EG002", "SeriousEventStatsNumAffected":"1", "SeriousEventStatsNumAtRisk":"512" } ] } },{ "SeriousEventTerm":"Haemorrhoids", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventSourceVocabulary":"MedDRA Version 17.1", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"1429" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumAffected":"0", "SeriousEventStatsNumAtRisk":"504" },{ 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