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Statistical Analysis Plan CONFIDENTIAL The GlaxoSmithKline group of companies 209035 Division : Worldwide Development Information Type : Reporting and Analysis Plan (RAP) Title : Reporting and Analysis Plan for A Phase IIb, Multicenter, Open-label, Rollover Study Evaluating the Efficacy, Safety and Tolerability of Long-acting Cabotegravir Plus Long- acting Rilpivirine Administered Every Two Months in HIV-1 infected Adults who are Virologically Suppressed and Participated in Study LAI116482 Compound Number : GSK1265744 Effective Date : 31-JAN-2020 Description: The purpose of this RAP is to describe the planned analyses and output to be included in the Clinical Study Report for Protocol 209035. This RAP is intended to describe the efficacy, safety and tolerability 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. RAP Author(s): Approver Date Approval Method PPD 31-01-2020 Email Senior Statistician II, Quanticate Copyright 2020 the GlaxoSmithKline group of companies. All rights reserved. Unauthorised copying or use of this information is prohibited. 1 CONFIDENTIAL The GlaxoSmithKline group of companies 209035 RAP Team Approvals: Approver Date Approval Method PPD Clinical Development Manager, ([HIV] [ViiV 31-01-2020 Email Sci Med Officer]) PPD Email Programming Manager (HIV, Clinical 31-01-2020 Programming) Clinical Statistics and Clinical Programming Line Approvals: Approver Date Approval Method PPD Manager, Statistics (Infectious Diseases, Clinical 31-01-2020 Email Statistics) PPD Programming Manager (Infectious Diseases, 31-01-2020 Email Clinical Programming) 2 CONFIDENTIAL 209035 TABLE OF CONTENTS PAGE 1. INTRODUCTION......................................................................................................6 2. SUMMARY OF KEY PROTOCOL INFORMATION ..................................................6 2.1. Changes to the Protocol Defined Statistical Analysis Plan ............................6 2.2. Study Objective(s) and Endpoint(s)...............................................................6 2.3. Study Design ................................................................................................8 2.4. Statistical Hypotheses / Statistical Analyses .................................................9 3. PLANNED ANALYSES ..........................................................................................10 3.1. Interim Analyses .........................................................................................10 3.2. Final Analyses ............................................................................................10 4. ANALYSIS POPULATIONS ...................................................................................10 4.1. Protocol Deviations.....................................................................................11 5. CONSIDERATIONS FOR DATA ANALYSES AND DATA HANDLING CONVENTIONS.....................................................................................................12 5.1. Study Treatment & Sub-group Display Descriptors .....................................12 5.2. Baseline Definitions ....................................................................................12 5.3. Multicentre Studies .....................................................................................12 5.4. Examination of Covariates, Other Strata and Subgroups ............................12 5.4.1. Covariates and Other Strata ........................................................12 5.4.2. Examination of Subgroups...........................................................13 5.5. Multiple Comparisons and Multiplicity .........................................................14 5.5.1. Primary Comparison of Interest ...................................................14 5.6. Other Considerations for Data Analyses and Data Handling Conventions................................................................................................14 6. STUDY POPULATION ANALYSES .......................................................................15 6.1. Overview of Planned Study Population Analyses........................................15 6.2. Prior and Concomitant Medications ............................................................16 7. EFFICACY ANALYSES..........................................................................................18 7.1. Primary Efficacy Analyses ..........................................................................18 7.1.1. Endpoint / Variables.....................................................................18 7.1.2. Summary Measure ......................................................................18 7.1.3. Population of Interest...................................................................18 7.1.4. Strategy for Intercurrent (Post-treatment selection) Events..........18 7.1.5. Statistical Analyses / Methods .....................................................18 7.2. Secondary Efficacy Analyses......................................................................19 7.2.1. Endpoint / Variables.....................................................................19 7.2.2. Summary Measure ......................................................................19 7.2.3. Population of Interest...................................................................19 7.2.4. Strategy for Intercurrent (Post-treatment selection) Events..........19 7.2.5. Statistical Analyses / Methods .....................................................19 7.3. Exploratory Efficacy Analyses.....................................................................20 8. SAFETY ANALYSES .............................................................................................21 8.1. Adverse Events Analyses ...........................................................................21 3 CONFIDENTIAL 209035 8.1.1. Injection Site Reactions ...............................................................21 8.2. Clinical Laboratory Analyses.......................................................................21 8.3. Adverse Events of Special Interest Analyses ..............................................22 8.4. Other Safety Analyses ................................................................................23 9. HEALTH OUTCOMES ANALYSES........................................................................23 9.1. Endpoint / Variables....................................................................................23 9.2. Summary Measure .....................................................................................24 9.3. Population of Interest..................................................................................24 9.4. Strategy for Intercurrent (Post-treatment selection) Events.........................24 9.5. Statistical Analyses / Methods ....................................................................24 10. VIROLOGY ............................................................................................................24 11. REFERENCES.......................................................................................................26 12. APPENDICES ........................................................................................................27 12.1. Appendix 1: Protocol Deviation Management and Definitions for Per Protocol Population.....................................................................................27 12.1.1. Exclusions from Per Protocol Population .....................................27 12.2. Appendix 2: Schedule of Activities ..............................................................29 12.2.1. Protocol Defined Schedule of Events for CAB LA + RPV LA Q2M Administration................................................................29 12.2.2. Protocol Defined Schedule of Events for DTG + RPV Administration..............................................................................33 12.2.3. Protocol Defined Schedule of Events for Long Term Follow Up.....................................................................................35 12.3. Appendix 3: Assessment Windows .............................................................37 12.3.1. Definitions of Assessment Windows for Analyses ........................37 12.3.2. Definitions of Assessment Windows for Data Other than Health Outcomes.........................................................................37 12.3.3. Assessment Window for Study Conclusion ..................................41 12.3.4. Assessment Window for Health Outcome Data ...........................41 12.3.4.1. HIVTSQs, HIVTSQc, HIVDQoL, Preference...............41 12.3.4.2. Reasons for Switch.....................................................42 12.3.5. Multiple assessments within an Analysis Window........................42 12.4. Appendix 4: Study Phases and Treatment State.........................................43 12.4.1. Study Phases ..............................................................................43 12.4.2. Treatment State...........................................................................44 12.4.2.1. Treatment States for AE Data.....................................45 12.5. Appendix 5: Data Display Standards & Handling Conventions....................47 12.5.1. Reporting Process .......................................................................47 12.5.2. Reporting Standards....................................................................47 12.6. Appendix 6: Derived
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