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Statistical Analysis Plan – Part 1

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Statistical Analysis Plan – Part 1 NCT03251482 Janssen Research & Development Statistical Analysis Plan – Part 1 A Randomized, Double-blind, Double-dummy, Multicenter, Adaptive Design, Dose Escalation (Part 1) and Dose-Response (Part 2) Study to Evaluate the Safety and Efficacy of Intravenous JNJ-64179375 Versus Oral Apixaban in Subjects Undergoing Elective Total Knee Replacement Surgery Protocol 64179375THR2001; Phase 2 JNJ-64179375 Status: Approved Date: 18 October 2017 Prepared by: Janssen Research & Development, LLC Document No.: EDMS-ERI-148215770 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: 18 October 2017 JNJ-64179375 NCT03251482 Statistical Analysis Plan - Part 1 64179375THR2001 TABLE OF CONTENTS TABLE OF CONTENTS ............................................................................................................................... 2 LIST OF IN-TEXT TABLES AND FIGURES ................................................................................................ 3 ABBREVIATIONS ........................................................................................................................................ 4 1. INTRODUCTION.................................................................................................................................. 5 1.1. Trial Objectives ................................................................................................................................ 5 1.2. Trial Design ...................................................................................................................................... 6 1.3. Statistical Hypotheses for Trial Objectives....................................................................................... 7 1.4. Sample Size Justification ................................................................................................................. 7 1.5. Randomization and Blinding ............................................................................................................ 8 2. GENERAL ANALYSIS DEFINITIONS ................................................................................................ 9 2.1. Visit Windows................................................................................................................................... 9 2.2. Pooling Algorithm for Analysis Centers.......................................................................................... 10 2.3. Definition of Trial Dates.................................................................................................................. 11 2.4. Analysis Sets.................................................................................................................................. 11 2.4.1. All Enrolled Analysis Set............................................................................................................. 11 2.4.2. All Randomized Analysis Set...................................................................................................... 11 2.4.3. Efficacy Analysis Set(s) .............................................................................................................. 12 2.4.3.1. Primary Efficacy Analysis Set.................................................................................................. 12 2.4.3.2. Secondary Efficacy Analysis Set............................................................................................. 12 2.4.4. Safety Analysis Set..................................................................................................................... 13 2.4.5. Pharmacokinetics Analysis Set .................................................................................................. 13 2.4.6. Immunogenicity Analysis Set...................................................................................................... 13 2.4.7. Pharmacodynamics Analysis Set ............................................................................................... 13 2.5. Definition of Subgroups.................................................................................................................. 13 2.6. Study Day and Relative Day .......................................................................................................... 14 2.7. Baseline and Endpoint ................................................................................................................... 14 2.8. Imputation Rules for Missing AE Date/Time of Onset/Resolution ................................................. 14 3. INTERIM ANALYSIS AND DATA MONITORING COMMITTEE REVIEW....................................... 15 3.1. Operations Committee Review ...................................................................................................... 15 3.1.1. Dose Escalation Decision Guidelines......................................................................................... 16 4. SUBJECT INFORMATION................................................................................................................ 17 4.1. Demographics and Baseline Characteristics ................................................................................. 17 4.2. Disposition Information................................................................................................................... 18 4.3. Treatment Compliance................................................................................................................... 18 4.4. Extent of Exposure......................................................................................................................... 19 4.5. Protocol Deviations ........................................................................................................................ 20 4.6. Prior and Concomitant Medications............................................................................................... 20 5. EFFICACY ......................................................................................................................................... 20 5.1. Analysis Specifications................................................................................................................... 20 5.1.1. Level of Significance................................................................................................................... 20 5.1.2. Data Handling Rules................................................................................................................... 21 5.2. Primary Efficacy Endpoint(s).......................................................................................................... 21 5.2.1. Definition..................................................................................................................................... 21 5.2.2. Estimand..................................................................................................................................... 21 5.2.3. Analysis Methods........................................................................................................................ 22 5.3. Major Secondary Endpoints........................................................................................................... 23 5.3.1. Definition..................................................................................................................................... 23 5.3.2. Analysis Methods........................................................................................................................ 24 5.4. Other Efficacy Variable(s) .............................................................................................................. 24 2 Approved, Date: 18 October 2017 JNJ-64179375 NCT03251482 Statistical Analysis Plan - Part 1 64179375THR2001 5.4.1. Definition..................................................................................................................................... 24 5.4.2. Analysis Methods........................................................................................................................ 25 6. SAFETY ............................................................................................................................................. 25 6.1. Primary Safety (Bleeding) Endpoint............................................................................................... 25 6.1.1. Definition..................................................................................................................................... 25 6.1.2. Safety (Bleeding) Analysis Methods........................................................................................... 25 6.2. Major (Key) Secondary Safety Endpoints...................................................................................... 27 6.3. Other Secondary Safety Endpoints................................................................................................ 27 6.4.
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