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Sap-Ubr-Md-04 Amendment 2 NCT02873221 Study ID: UBR‐MD‐04 Title: A Multicenter, Randomized, Open‐Label Extension Study to Evaluate the Long‐Term Safety and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine With or Without Aura Statistical Analysis Plan Amd 2 Date: 04‐Sept‐2018 Allergan Confidential SAP UBR-MD-04 Amendment 1 Ubrogepant 1. Title Page STATISTICAL ANALYSIS PLAN A MULTICENTER, RANDOMIZED, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY AND TOLERABILITY OF ORAL UBROGEPANT IN THE ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA Amendment 2: 2018-09-04 Protocol Number: UBR-MD-04 Amendment 2 Development Phase: 3 Product Name: Ubrogepant Study Statistician: . Sponsor: Allergan Pharmaceuticals 2525 Dupont Drive Irvine, California USA 92612 +1-714-246-4500 +1-800-347-4500 This document is the property of Allergan. and may not—in full or part—be passed on, reproduced, published, distributed to any person, or submitted to any regulatory authority without the express written permission of Allergan. 1 Allergan Confidential SAP UBR-MD-04 Amendment 1 Ubrogepant 2. Table of Contents 1. Title Page ..............................................................................................................................................1 2. Table of Contents..................................................................................................................................2 2.1 List of Tables.............................................................................................................................. 3 2.2 List of Figures............................................................................................................................. 5 3. List of Abbreviations and Definition of Terms.....................................................................................6 4. Introduction...........................................................................................................................................8 4.1 Study Design Summary ..............................................................................................................8 4.2 Study Objectives and Endpoints.................................................................................................8 5. Statistical Methodology and Study Endpoints ....................................................................................13 5.1 Statistical Methods Planned in the Protocol and Determination of Sample Size .....................13 5.1.1 Statistical and Analytical Plans ...................................................................................13 5.1.1.1 Common Conventions .................................................................................13 5.1.1.2 Demographics..............................................................................................18 5.1.1.4 Safety Analyses ...........................................................................................26 5.1.1.5 Subgroup Analyses......................................................................................34 5.1.1.6 Interim Analyses..........................................................................................34 5.2 Changes in the Conduct of the Study or Planned Analyses......................................................35 5.2.1 Changes in the Conduct of the Study ..........................................................................35 5.2.2 Changes to Analyses Prior to Database Lock..............................................................35 6. Data Handling and Analysis Conventions ..........................................................................................36 6.1 Study Treatment Conventions ..................................................................................................36 6.1.1 Analysis Days..............................................................................................................36 6.1.2 Missing/Incomplete Treatment End Date....................................................................36 6.2 Analysis Visit Windows ...........................................................................................................36 6.2.2 Safety...........................................................................................................................37 2 Allergan Confidential SAP UBR-MD-04 Amendment 1 Ubrogepant 6.3.4.2 AE Group of Interest ...................................................................................40 6.3.5 Clinical Laboratory Assessments ................................................................................41 6.3.5.1 Potentially Clinically Significant Criteria ...................................................41 6.3.5.2 Hepatic Laboratory Abnormalities ..............................................................42 6.3.5.3 Continuous Descriptives and Shift Table Parameters..................................44 6.3.5.4 Character Values..........................................................................................44 6.3.6 Vital Signs ...................................................................................................................44 6.3.6.1 Potentially Clinically Significant Criteria ...................................................44 6.3.6.2 Continuous Descriptives and Shift Table Parameters..................................45 6.3.7 Electrocardiograms......................................................................................................45 6.3.7.1 QTc Derivation............................................................................................45 6.3.7.2 Potentially Clinically Significant Criteria ...................................................45 6.3.7.3 Continuous Descriptives and Shift Table Parameters..................................46 6.4 Imputed Value Listing Conventions.........................................................................................46 7. Amendment(s).....................................................................................................................................46 8. Appendices..........................................................................................................................................48 8.1 Appendix I: Preferred Terms for AE Categories of Clinical Interest Created by SMQs..........48 2.1 List of Tables Table 3-1 Abbreviations and Definitions of Terms.............................................................................6 Table 4-1 Study Objectives and Corresponding Endpoints ................................................................ 9 Table 5-1 Analysis Populations.........................................................................................................13 Table 5-2 Statistical Methodology ....................................................................................................14 Table 5-3 Missing Data Handling by Endpoint Type .......................................................................15 Table 5-4 Analysis Population Summaries .......................................................................................18 Table 5-5 Participant Disposition Summaries...................................................................................18 Table 5-6 Classification of Renal Function Based on Estimated GFR (eGFR) ................................19 Table 5-7 Protocol Deviation Summary............................................................................................20 Table 5-8 Demographic Summaries..................................................................................................20 3 Allergan Confidential SAP UBR-MD-04 Amendment 1 Ubrogepant Table 5-9 Baseline Characteristics Summaries.................................................................................20 Table 5-10 Medical History Summary................................................................................................21 Table 5-11 Migraine History Summary ..............................................................................................21 Table 5-12 Medication Summaries .....................................................................................................22 Table 5-16 Safety Endpoint Baseline Definitions...............................................................................26 Table 5-17 Treatment Exposure Summaries.......................................................................................27 Table 5-18 Treatment Compliance Summaries...................................................................................28 Table 5-19 AE Terms..........................................................................................................................28 Table 5-20 AE Summaries ..................................................................................................................29 Table 5-21 Clinical Laboratory Summaries ........................................................................................31 Table 5-22 Potential Hy's Law Summaries.........................................................................................32 Table 5-23 Vital Signs Summaries......................................................................................................32 Table 5-24 ECG Summaries ...............................................................................................................33 Table 5-25 Cardiovascular Risk Summaries.......................................................................................34
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