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STATISTICAL ANALYSIS PLAN Study Title STATISTICAL ANALYSIS PLAN Study Title: A Phase 3, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Switching from Tenofovir Disoproxil Fumarate (TDF) 300 mg QD to Tenofovir Alafenamide (TAF) 25 QD in Subjects with Chronic Hepatitis B who are Virologically Suppressed Name of Test Drug: Tenofovir Alafenamide (TAF) Study Number: GS-US-320-4018 Protocol Version (Date): Amendment 1 (21 December 2016) Analysis Type: Week 48 Analysis Analysis Plan Version: 1.0 Analysis Plan Date: 17 October 2018 Analysis Plan Author(s): PPD CONFIDENTIAL AND PROPRIETARY INFORMATION TABLE OF CONTENTS STATISTICAL ANALYSIS PLAN..............................................................................................................................1 TABLE OF CONTENTS ..............................................................................................................................................2 LIST OF IN- TEXT TABLES.......................................................................................................................................4 LIST OF IN- TEXT FIGURES .....................................................................................................................................4 LIST OF ABBREVIATIONS........................................................................................................................................5 1. INTRODUCTION ................................................................................................................................................8 1.1. Study Objectives ......................................................................................................................................8 1.2. Study Design ............................................................................................................................................9 1.2.1. Design Configuration and Subject Population .......................................................................9 1.2.2. Treatment Groups and Randomization...................................................................................9 1.2.3. Key Eligibility Criteria...........................................................................................................9 1.2.4. Study Periods and Phases.....................................................................................................10 1.2.5. Schedule of Assessments......................................................................................................10 1.3. Sample Size and Power..........................................................................................................................11 2. TYPE OF PLANNED ANALYSIS ....................................................................................................................12 2.1. Data Monitoring Committee (DMC) Analysis.......................................................................................12 2.2. Week 48 Analysis (Primary Analysis) ...................................................................................................12 2.3. Final Analysis ........................................................................................................................................12 3. GENERAL CONSIDERATIONS FOR DATA ANALYSES ............................................................................13 3.1. Analysis Sets ..........................................................................................................................................13 3.1.1. Randomized Analysis Set.....................................................................................................13 3.1.2. Safety Analysis Set...............................................................................................................13 3.1.3. Full Analysis Set ..................................................................................................................13 3.1.4. Per Protocol Analysis Set .....................................................................................................14 3.1.5. Serologically Evaluable Full Analysis Set ...........................................................................14 3.1.6. DXA Analysis Set ................................................................................................................15 3.2. Subject Grouping ...................................................................................................................................15 3.3. Strata and Covariates..............................................................................................................................15 3.4. Examination of Subject Subgroups ........................................................................................................15 3.5. Multiple Comparisons............................................................................................................................16 3.6. Missing Data and Outliers......................................................................................................................17 3.6.1. Missing Data ........................................................................................................................17 3.6.2. Outliers.................................................................................................................................18 3.7. Data Handling Conventions and Transformations .................................................................................18 3.8. Analysis Visit Windows.........................................................................................................................19 3.8.1. Definition of Study Day 1 and Other Definitions.................................................................19 3.8.2. Analysis Windows................................................................................................................20 3.8.3. Selection of Data in the Event of Multiple Records in an Analysis Visit Window................................................................................................................................23 4. SUBJECT DISPOSITION ..................................................................................................................................25 4.1. Subject Enrollment and Disposition.......................................................................................................25 4.2. Extent of Study Drug Exposure and Adherence.....................................................................................26 4.2.1. Duration of Exposure to Study Drug....................................................................................26 4.2.2. Adherence with Study Drug Regimen..................................................................................26 4.3. Protocol Deviations................................................................................................................................27 5. BASELINE CHARACTERISTICS....................................................................................................................28 TAF GS-US-320-4018 Statistical Analysis Plan Final 5.1. Demographics and Baseline Characteristics ..........................................................................................28 5.2. Medical History......................................................................................................................................29 5.3. Risk Factors for HBV Infections............................................................................................................29 6. EFFICACY ANALYSES ...................................................................................................................................30 6.1. Primary Efficacy Endpoint.....................................................................................................................30 6.1.1. Definition of the Primary Efficacy Endpoint .......................................................................30 6.1.2. Statistical Hypothesis for the Primary Efficacy Endpoint....................................................31 6.1.3. Analysis of the Primary Efficacy Endpoint..........................................................................31 6.1.4. Secondary Analyses for the Primary Efficacy Endpoint ......................................................32 6.1.5. Subgroup Analysis for the Primary Efficacy Endpoint ........................................................33 6.2. Secondary Efficacy Endpoints ...............................................................................................................33 6.2.1. Definition of Secondary Efficacy Endpoints........................................................................33 6.2.2. Analysis Methods for Secondary Efficacy Endpoints ..........................................................34 6.3. Changes From Protocol-Specified Efficacy Analyses............................................................................35 7. SAFETY ANALYSES........................................................................................................................................36 7.1. Adverse Events.......................................................................................................................................36 7.1.1. Adverse Event Dictionary ....................................................................................................36 7.1.2. Adverse Event Severity........................................................................................................36
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