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Title: a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Effica

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Title: a Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a Vedolizumab IV Reference Arm, to Evaluate the Effica Title: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy NCT Number: NCT02611830 SAP Approve Date: 2 June 2018 Certain information within this Statistical Analysis Plan has been redacted (ie, specific content is masked irreversibly from view with a black/blue bar) to protect either personally identifiable (PPD) information or company confidential information (CCI). This may include, but is not limited to, redaction of the following: Named persons or organizations associated with the study. Proprietary information, such as scales or coding systems, which are considered confidential information under prior agreements with license holder. • Other information as needed to protect confidentiality of Takeda or partners, personal information, or to otherwise protect the integrity of the clinical study. 1.0 TITLE PAGE TAKEDA DEVELOPMENT CENTER STATISTICAL ANALYSIS PLAN STUDY NUMBER: MLN0002SC-3027 A Phase 3 Randomized, Double-Blind, Placebo-Controlled Study, with a vedolizumab IV Reference Arm, to Evaluate the Efficacy and Safety of Vedolizumab Subcutaneous as Maintenance Therapy in Subjects with Moderately to Severely Active Ulcerative Colitis Who Achieved Clinical Response Following Open-Label Vedolizumab Intravenous Therapy PHASE 3 Version: 1.0 Date: 12 June 2018 Prepared by: PPD Based on: Protocol Version: <Amendment 4> Protocol Date: <26 July 2016> CONFIDENTIAL PROPERTY OF TAKEDA This document is a confidential communication of Takeda. Acceptance of this document constitutes the agreement by the recipient that no information contained herein will be published or disclosed without written authorization from Takeda. MLN0002SC-3027 Page 2 of 41 Statistical Analysis Plan Final v1.0 12 June 2018 1.1 APPROVAL SIGNATURES Electronic signatures can be found on the last page of this document. CONFIDENTIAL MLN0002SC-3027 Page 3 of 41 Statistical Analysis Plan Final v1.0 12 June 2018 2.0 TABLE OF CONTENTS 1.0 TITLE PAGE ..................................................................................................................1 1.1 APPROVAL SIGNATURES.....................................................................................2 2.0 TABLE OF CONTENTS.................................................................................................3 3.0 LIST OF ABBREVIATIONS..........................................................................................6 4.0 OBJECTIVES .................................................................................................................8 4.1 Primary Objectives ....................................................................................................8 4.2 Secondary Objectives.................................................................................................8 4.3 Exploratory Objectives ..............................................................................................8 4.4 Study Design .............................................................................................................9 5.0 ANALYSIS ENDPOINTS.............................................................................................12 5.1 Primary Endpoint.....................................................................................................12 5.2 Secondary Endpoints ...............................................................................................12 5.3 Patient Reported Outcome (PRO) Endpoints............................................................12 5.4 Exploratory Endpoints .............................................................................................12 5.4.1 Additional Exploratory Endpoints ......................................................................14 5.5 Safety Assessments..................................................................................................14 6.0 DETERMINATION OF SAMPLE SIZE.......................................................................15 7.0 METHODS OF ANALYSIS AND PRESENTATION...................................................16 7.1 General Considerations............................................................................................16 7.1.1 Study Terms and Definitions..............................................................................16 7.1.2 Convention for Calculations of Mayo Scores .....................................................17 7.1.3 Duplicate Records due to Patient Self-Entered Data ...........................................19 7.1.4 Convention for missing data...............................................................................19 7.1.5 Definition of Study Days and Visit Window ......................................................19 7.2 Analysis Sets ...........................................................................................................21 7.2.1 Full Analysis Set (FAS) .....................................................................................21 7.2.2 Per-Protocol Set (PPS) .......................................................................................21 7.2.3 Safety Analysis Set ............................................................................................21 7.2.4 Pharmacokinetic Set...........................................................................................21 7.3 Disposition of Subjects ............................................................................................21 7.4 Demographic and Baseline Characteristics...............................................................22 7.5 Medical History and Concurrent Medical Conditions ...............................................22 7.6 Medication History and Concomitant Medications and Procedures ..........................22 7.7 Study Drug Exposure and Compliance.....................................................................23 7.8 Efficacy Analysis.....................................................................................................23 CONFIDENTIAL MLN0002SC-3027 Page 4 of 41 Statistical Analysis Plan Final v1.0 12 June 2018 7.8.1 Primary Efficacy Endpoint.................................................................................24 7.8.2 Secondary Efficacy Endpoints............................................................................24 7.8.3 Patient Reported Outcomes (PROs) Endpoints...................................................26 7.8.4 Exploratory and additional Efficacy Endpoints...................................................26 7.8.5 Subgroup Analysis .............................................................................................26 7.8.6 Sensitivity Analysis............................................................................................28 7.9 Pharmacokinetic/Pharmacodynamic Analysis ..........................................................28 7.10 Other Outcomes.......................................................................................................28 7.10.1 Immunogenicity Endpoints ................................................................................28 7.10.2 Histological Endpoints .......................................................................................29 7.10.3 Resource Utilization and Patient-Reported Outcome Endpoints..........................29 7.11 Safety Analysis........................................................................................................30 7.11.1 Adverse Events ..................................................................................................30 7.11.2 Clinical Laboratory Evaluations .........................................................................31 7.11.3 Vital Signs .........................................................................................................31 7.11.4 12-Lead ECGs ...................................................................................................31 7.11.5 Other Observations Related to Safety.................................................................31 7.12 Interim Analysis ......................................................................................................32 7.13 Changes in the Statistical Analysis Plan...................................................................32 8.0 REFERENCES..............................................................................................................33 LIST OF IN-TEXT TABLES Table 7.a Example of eDiary Subscore Calculations for Eligibility Visit ...........................18 Table 7.b Example of eDiary Subscore Calculations for Non-eligibility Visits...................18 Table 7.c Visit Windows (Induction Period for Non-responders at Week 6) ......................20 Table 7.d Visit Windows (Randomized Subjects) ..............................................................20 LIST OF IN-TEXT FIGURES Figure 4.a Schematic of Study Design ................................................................................11 LIST OF APPENDICES Appendix A Criteria for Identification of Markedly Abnormal Laboratory Values .................34 Appendix B Criteria for Markedly Abnormal Values for Vital Signs......................................35 Appendix C Mayo Score Calculation Worksheet ...................................................................36
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