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Statistical Analysis Plan CONFIDENTIAL 2020N435253_00 The GlaxoSmithKline group of companies 206898 Division : Worldwide Development Information Type : Reporting and Analysis Plan (RAP) Title : Reporting and Analysis Plan for 206898: An Open Label, Phase 1 Study to Evaluate the PK, Safety, Tolerability and Acceptability of Long Acting Injections of the HIV Integrase Inhibitor, Cabotegravir (CAB; GSK1265744) in HIV Uninfected Chinese Men Compound Number : GSK1265744 Effective Date : 22-APR-2019 Description: The purpose of this RAP is to describe the planned analyses and output to be included in the Clinical Study Report for Protocol 206898. This RAP is intended to describe the safety, tolerability, and pharmacokinetic (PK) analyses required for the study. This RAP will be provided to the study team members to convey the content of the Statistical Analysis Complete (SAC) deliverable. Author’s Name and Functional Area: PPD 22-APR-2019 Senior Biostatistician, PPD PPD 22-APR-2019 Pharmacokineticist (Biostatistics, PPD) Approved by: PPD 22-APR-2019 Statistics Leader, GSK PPD 22-APR-2019 Manager Statistics Copyright 2019 the GlaxoSmithKline group of companies. All rights reserved. Unauthorised copying or use of this information is prohibited. 1 CONFIDENTIAL 2020N435253_00 206898 TABLE OF CONTENTS PAGE 1. REPORTING & ANALYSIS PLAN SYNOPSIS.........................................................5 2. SUMMARY OF KEY PROTOCOL INFORMATION ..................................................8 2.1. Changes to the Protocol Defined Statistical Analysis Plan ............................8 2.2. Study Objective(s) and Endpoint(s)...............................................................8 2.3. Study Design ................................................................................................9 2.4. Statistical Hypotheses.................................................................................10 3. PLANNED ANALYSES ..........................................................................................11 3.1. Interim Analyses .........................................................................................11 3.2. Final Analyses ............................................................................................11 4. ANALYSIS POPULATIONS ...................................................................................12 4.1. Protocol Deviations.....................................................................................13 5. CONSIDERATIONS FOR DATA ANALYSES AND DATA HANDLING CONVENTIONS.....................................................................................................14 6. STUDY POPULATION ANALYSES .......................................................................15 6.1. Overview of Planned Analyses ...................................................................15 6.1.1. Disposition ...................................................................................15 6.1.2. Demographics .............................................................................15 6.1.3. Medical History ............................................................................16 6.1.4. Prior and Concomitant Medications .............................................16 6.1.5. Protocol Deviation........................................................................16 7. PRIMARY STATISTICAL ANALYSES....................................................................17 7.1. Safety Analyses of CAB LA ........................................................................17 7.1.1. Injection Site Reaction .................................................................17 7.1.2. Adverse Events............................................................................18 7.1.3. Clinical Laboratory Tests .............................................................19 7.1.4. Vital Sign Assessments ...............................................................19 7.1.5. Death...........................................................................................20 7.2. Tolerability Analyses of CAB LA .................................................................21 7.3. Primary Pharmacokinetic Analyses.............................................................22 7.3.1. Overview of Planned Primary Pharmacokinetic Analyses ............22 7.3.2. Primary Drug Concentration Measures ........................................22 7.3.3. Primary Pharmacokinetic Parameters..........................................23 7.3.3.1. Deriving Primary Pharmacokinetic Parameters...........23 7.3.3.2. Statistical Analysis of Primary Pharmacokinetic Parameters.................................................................24 8. SECONDARY STATISTICAL ANALYSES .............................................................25 8.1. Secondary Pharmacokinetic Analyses ........................................................25 8.1.1. Overview of Planned Secondary Pharmacokinetic Analyses......................................................................................25 8.1.2. Secondary Drug Concentration Measures ...................................25 8.1.3. Secondary Pharmacokinetic Parameters .....................................25 2 CONFIDENTIAL 2020N435253_00 206898 8.1.3.1. Deriving Secondary Pharmacokinetic Parameters.................................................................25 8.2. Safety and Tolerability Analyses of Oral CAB .............................................26 8.3. Acceptability of CAB LA..............................................................................27 8.4. Concentration-effect Relationships for Safety and Tolerability Parameters.................................................................................................28 8.5. General Safety Analyses ............................................................................28 8.5.1. Extent of Exposure to CAB ..........................................................28 8.5.2. Possible suicidality-related Adverse Events .................................29 8.5.3. Social Harms ...............................................................................29 8.5.4. ECG.............................................................................................30 8.5.5. Cardiovascular Events.................................................................30 8.5.6. Liver Events.................................................................................30 9. REFERENCES.......................................................................................................32 10. APPENDICES ........................................................................................................33 10.1. Appendix 1: Protocol Deviation Management and Definitions for Per Protocol Population.....................................................................................34 10.1.1. Exclusions from Per Protocol Population .....................................34 10.2. Appendix 2: Time & Events.........................................................................35 10.2.1. Protocol Defined Time & Events ..................................................35 10.3. Appendix 3: Assessment Windows .............................................................39 10.3.1. Assessment Windows..................................................................39 10.4. Appendix 4: Study Phase and State............................................................40 10.4.1. Treatment Phases .......................................................................40 10.4.2. Treatment States .........................................................................40 10.4.2.1. Treatment States for AE Data.....................................40 10.5. Appendix 5: Data Display Standards & Handling Conventions....................41 10.5.1. Study Treatment & Sub-group Display Descriptors ......................41 10.5.2. Baseline Definition & Derivations .................................................41 10.5.2.1. Baseline Definitions....................................................41 10.5.2.2. Derivations and Handling of Missing Baseline Data ...........................................................................41 10.5.3. Reporting Process & Standards...................................................41 10.6. Appendix 6: Derived and Transformed Data ...............................................44 10.6.1. General........................................................................................44 10.6.2. Study Population..........................................................................44 10.6.3. Safety ..........................................................................................45 10.7. Appendix 7: Premature Withdrawals & Handling of Missing Data ...............46 10.7.1. Premature Withdrawals................................................................46 10.7.2. Handling of Missing Data .............................................................46 10.7.2.1. Handling of Missing Dates..........................................46 10.7.2.2. Handling of Partial Dates............................................46 10.7.2.3. Handling of Missing Data for Statistical Analysis......................................................................47 10.8. Appendix 8: Values of Potential Clinical Importance ...................................48 10.8.1. Laboratory Values........................................................................48 10.8.2. ECG.............................................................................................49 10.8.3.
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