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Statistical Analysis Plan NCT02431702 Janssen Research & Development, LLC Statistical Analysis Plan A Prospective, Matched-Control, Randomized, Open-Label, Flexible-Dose, Study in Subjects with Recent-Onset Schizophrenia or Schizophreniform Disorder to Compare Disease Progression and Disease Modification Following Treatment with Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics Disease Recovery Evaluation and Modification (DREaM) Study Phase 3b Protocol R092670SCH3013 R092670 (paliperidone palmitate) Status: Approved Date: 6 December 2019 Prepared by: Janssen Research & Development, LLC Document No.: EDMS-ERI-201245942, 1.0 Compliance: The study described in this report was performed according to the principles of Good Clinical Practice (GCP). Confidentiality Statement The information in this document contains trade secrets and commercial information that are privileged or confidential and may not be disclosed unless such disclosure is required by applicable law or regulations. In any event, persons to whom the information is disclosed must be informed that the information is privileged or confidential and may not be further disclosed by them. These restrictions on disclosure will apply equally to all future information supplied to you that is indicated as privileged or confidential. 1 Approved, Date: 6 December 2019 NCT02431702 R092670 (paliperidone palmitate) Statistical Analysis Plan R092670SCH3013 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 ABBREVIATIONS ........................................................................................................................................ 5 1. INTRODUCTION.................................................................................................................................. 6 1.1. Trial Objectives ................................................................................................................................ 6 1.2. Trial Design .................................................................................................................................... 10 1.3. Statistical Hypotheses for Trial Objectives..................................................................................... 16 1.3.1. Part II: Disease Progression....................................................................................................... 17 1.3.2. Part III: Extended Disease Progression and Disease Modification ............................................ 18 1.3.2.1. Extended Disease Progression ............................................................................................... 18 1.3.2.2. Disease Modification ............................................................................................................... 19 1.4. Sample Size Determination ........................................................................................................... 20 1.5. Randomization and Blinding .......................................................................................................... 21 2. GENERAL ANALYSIS DEFINITIONS .............................................................................................. 23 2.1. Analysis Phases............................................................................................................................. 23 TIME AND EVENTS SCHEDULE: SCREENING....................................................................................... 24 TIME AND EVENTS SCHEDULE: PART I, PART II, AND PART III......................................................... 25 2.1.1. Study Reference Start and End Dates ....................................................................................... 27 2.1.2. Analysis Phase Start and End Dates.......................................................................................... 27 2.1.3. Study Day and Relative Day....................................................................................................... 28 2.2. Baseline and End Point.................................................................................................................. 28 2.3. Flagging Treatment Failures for Primary Analysis ..................................................................... 29 2.4. Visit Windows................................................................................................................................. 29 2.5. Analysis Sets.................................................................................................................................. 39 2.6. Definition of Subgroups.................................................................................................................. 40 2.7. Imputation Rules for Missing Dates ............................................................................................... 41 2.7.1. Missing AE Dates ....................................................................................................................... 41 2.7.2. Missing Concomitant Medication Dates ..................................................................................... 42 2.7.3. Baseline Hospitalization Dates ................................................................................................... 42 2.7.4. Baseline Characteristics and Prior Medications ......................................................................... 43 2.7.5. Post Part I Baseline Hospitalization, Emergency Room Visit Dates .......................................... 43 3. RULES FOR PRESENTATIONS....................................................................................................... 44 4. SUBJECT INFORMATION................................................................................................................ 45 4.1. Discontinuation/Completion Information ........................................................................................ 45 4.2. Demographics and Baseline Characteristics ................................................................................. 45 4.3. Extent of Treatment Exposure ....................................................................................................... 47 4.3.1. Injections..................................................................................................................................... 47 4.3.2. Oral Antipsychotics ..................................................................................................................... 47 4.4. Protocol Deviations ........................................................................................................................ 47 4.5. Prior and Concomitant Medications ............................................................................................... 47 4.5.1. Prior Psychotropic Medications .................................................................................................. 48 4.5.2. Concomitant Benzodiazepines (Sedatives/Hypnotics/Anxiolytics)............................................. 48 4.5.3. Concomitant Medications Other Than Benzodiazepines ........................................................... 49 4.5.4. Concomitant Antiparkinsonian Medications................................................................................ 49 5. EFFICACY ......................................................................................................................................... 49 5.1. Level of Significance ...................................................................................................................... 49 5.2. Part II, Primary Efficacy Endpoint .................................................................................................. 51 5.2.1. Primary Estimand ....................................................................................................................... 52 2 Approved, Date: 6 December 2019 NCT02431702 R092670 (paliperidone palmitate) Statistical Analysis Plan R092670SCH3013 5.2.2. Analysis Methods........................................................................................................................ 53 5.2.3. Model Diagnostics ...................................................................................................................... 54 5.2.4. Subgroup Analyses..................................................................................................................... 54 5.2.5. Time to Treatment Failure by Reason ........................................................................................ 54 5.2.6. Multiple Events ........................................................................................................................... 55 5.3. Part II, Key Secondary Endpoints .................................................................................................. 55 5.3.1. MCCB – MATRICS Consensus Cognitive Battery ..................................................................... 56 5.3.1.1. Definition.................................................................................................................................. 56 5.3.1.2. Analysis Methods .................................................................................................................... 58 5.3.2. PSP - Personal and Social Performance Scale ......................................................................... 59 5.3.2.1. Definition.................................................................................................................................
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