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Statistical Analysis Plan Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 Emergent BioSolutions STATISTICAL ANALYSIS PLAN Study Drug Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 Safety and Pharmacokinetic Evaluation of Zika Virus Immune Globulin in Healthy Volunteers Protocol Version Date Protocol 1.0 30-OCT-2017 Amendment 2.0 30-NOV-2017 Amendment 2.1 10-JAN-2018 Amendment 3.0 18-APR-2018 Amendment 3.1 05-JUN-2018 SAP Version Date 1.0 FINAL 18-APR-2019 Confidential and Proprietary 1 Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 TABLE OF CONTENTS TABLE OF CONTENTS .................................................................................................................3 LIST OF ABBREVIATIONS ..........................................................................................................6 1. INTRODUCTION ........................................................................................................8 2. PROTOCOL SUMMARY ............................................................................................8 2.1. Study Objectives ...........................................................................................................8 2.1.1. Primary Objective .........................................................................................................8 2.1.2. Secondary Objective .....................................................................................................8 2.2. Study Design and Conduct ...........................................................................................8 2.3 Study Endpoints ............................................................................................................9 2.3.1 Efficacy Endpoints ........................................................................................................9 2.3.2 Safety Endpoints ...........................................................................................................9 2.3.2.1 Primary Safety Endpoint ...............................................................................................9 2.3.2.2 Secondary Safety Endpoints .........................................................................................9 2.3.3 Pharmacokinetic Endpoints ..........................................................................................9 2.4 Power and Sample Size Considerations .....................................................................10 2.5 Randomization and Blinding ......................................................................................10 3 DATA CONSIDERATIONS ......................................................................................11 3.1 Protocol Deviations ....................................................................................................11 3.2 Analysis Populations ..................................................................................................11 3.3 Multicenter Study .......................................................................................................11 3.4 Analysis Time Points ..................................................................................................12 3.5 Definition of Baseline .................................................................................................12 3.6 Treatment Groups .......................................................................................................12 3.7 Coding Dictionaries ....................................................................................................12 4 STATISTICAL ANALYSIS ......................................................................................15 4.1 Statistical Software .....................................................................................................15 4.2 Summary Statistics .....................................................................................................15 4.3 Derived Variables .......................................................................................................15 4.4 Statistical Hypotheses .................................................................................................16 4.5 Handling of Missing Data ...........................................................................................17 Confidential and Proprietary 3 Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 4.6 Adjustment for Covariates ..........................................................................................17 4.7 Subgroup Analysis ......................................................................................................17 4.8 Multiplicity Adjustment..............................................................................................17 5 STUDY POPULATION CHARACTERISTICS .......................................................17 5.1 Subject Disposition .....................................................................................................17 5.2 Protocol Deviations ....................................................................................................17 5.3 Demographics and Other Baseline Characteristics .....................................................17 5.3.1 Demographics .............................................................................................................17 5.3.2 Baseline Viral Markers ...............................................................................................18 5.3.3 Medical History ..........................................................................................................18 5.3.4 Screening Smoking History ........................................................................................18 5.3.5 Breath Alcohol Test at Screening and Baseline .........................................................18 5.3.6 Urine Drug Test at Screening and Baseline ................................................................18 5.3.7 Pregnancy Test at Screening and Baseline .................................................................18 5.3.8 Screening Urinalysis ...................................................................................................18 5.3.9 Screening Electrocardiogram ......................................................................................19 5.3.10 Concomitant Medications ...........................................................................................19 6 EFFICACY ANALYSIS ............................................................................................19 7 SAFETY ANALYSIS ................................................................................................19 7.1 Extent of Exposure .....................................................................................................19 7.2 Primary Safety Analysis .............................................................................................19 7.2.1 Adverse Events ...........................................................................................................19 7.3 Secondary Safety Analysis .........................................................................................20 7.3.1 Clinical Laboratory Tests ...........................................................................................20 7.3.2 Viral Markers ..............................................................................................................20 7.3.3 Vital Signs ..................................................................................................................20 7.3.4 Physical Examinations ................................................................................................21 7.4 Pharmacokinetic Analyses ..........................................................................................21 7.4.1 Anti-ZIKV E-protein Binding Antibodies ..................................................................21 7.4.2 Anti-ZIKV NS1 Binding Antibodies ..........................................................................22 7.4.3 Anti-ZIKV Neutralizing Antibodies ...........................................................................22 Confidential and Proprietary 4 Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 8 SAFETY MONITORING COMMITTEE AND INTERIM ANALYSES ................22 8.1 Safety Monitoring Committee ....................................................................................22 8.2 Interim Analyses .........................................................................................................22 9 REFERENCES ...........................................................................................................23 10 APPENDIX I AESI PREFERRED TERM LIST .......................................................24 10.1 Preferred Terms for Modified Hypersensitivity SMQ ................................................24 10.2 Preferred Terms for Modified Renal Dysfunction SMQ ............................................28 10.3 Preferred Terms for Modified Aseptic Meningitis Syndrome SMQ ..........................29 10.4 Preferred Terms for Modified Hemolysis SMQ .........................................................29 10.5 Preferred Terms for Modified Thrombosis SMQ .......................................................30 10.6 Preferred Terms for Modified Transfusion-related Acute Lung Injury SMQ ............35 Confidential and Proprietary 5 Zika Virus Immune Globulin (Human) (ZIKV-IG) Protocol ZK-001 LIST OF ABBREVIATIONS AE Adverse event AESI Adverse event
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