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Statistical Analysis Plan Title: Clinical effectiveness and safety of vedolizumab intravenous in real world clinical practice in ulcerative colitis Korean patients: a multicenter postmarketing observational study NCT Number: NCT03535649 SAP Approve Date: 03 DEC 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. CCI Statistical Analysis Plan Page 1 of 60 Statistical Analysis Plan STUDY ID: VEDOLIZUMAB-5045 TITLE: C LINICAL EFFECTIVENESS AND SAFETY OF VEDOLIZUMAB INTRAVENOUS IN REAL WORLD CLINICAL PRACTICE IN ULCERATIVE COLITIS KOREAN PATIENTS: A MULTICENTER POST-MARKETING OBSERVATIONAL STUDY SHORT TITLE: VEDOLIZUMAB IN ULCERATIVE COLITIS KOREAN PATIENTS Prepared for: Takeda Pharmaceuticals Korea Co., Ltd. PPD AUTHOR: VERSION NUMBER AND DATE: V2.0; 03 DEC 2018 Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use Document: Takeda_SAP_Vedolizumab-5045_v2.0_20181203.docx Author: PPD Version Number: 2.0 Version Date: 03 DEC 2018 Page 2 of 42 CCI S STATISTICAL ANALYSIS PLAN SIGNATURE PAGE Statistical Analysis Plan (V2.0, 03 DEC 2018) for Protocol Vedolizumab-5045 V4.2 Name Signature Date Author: Ivan John Clement PPD Position: P Company: I N Approved By: Position: C Company: T PPD Document: Takeda_SAP_Vedolizumab-5045_v2.0_20181203.docx Author: Ivan John Clement Version Number: 2.0 Version Date: 03 DEC 2018 Property of Takeda: For non-commercial use only and subject to the applicable Terms of Use Templ CCI Effecti Copyright © 2018 IQVIA. All rights reserved. The contents of this document are confidential and proprietary to IQVIA Holdings Inc. and its subsidiaries. Unauthorized use, disclosure or reproduction is strictly prohibited. CCI Page 3 of 45 Statistical Analysis Plan Template MODIFICATION HISTORY Unique Date of the Author Significant Changes from Identifier Document Previous Authorized Version for this Version Version 1.0 25-SEP- Ye Qing Not Applicable – First draft 2018 2.0 03-DEC- Ivan John Clement Updated based on Protocol Version 4.2 2018 Updated to include analyses sets for data points recorded within ±7 days of protocol-defined visits PropertyDocument: of Takeda: Takeda_SAP_Vedolizumab For non-commercial-5045_v2.0_20181203.docx use only and subject to the applicable Terms of Use Author: PPD Version Number: 2.0 Version Date: 03 DEC 2018 CCI CCI Page 4 of 45 Statistical Analysis Plan Template TABLE OF CONTENTS 1. ABBREVIATIONS ........................................................................................................ 6 2. INTRODUCTION .......................................................................................................... 8 2.1 Ulcerative Colitis ................................................................................................. 8 2.2 Vedolizumab ........................................................................................................ 9 2.3 Study Rationale .................................................................................................. 11 3. STUDY OBJECTIVES ................................................................................................ 12 3.1 Primary Objectives............................................................................................. 12 3.2 Secondary Objectives......................................................................................... 12 3.3 Exploratory Objectives. ..................................................................................... 12 4. STUDY DESIGN AND PLAN .................................................................................... 13 4.1 General Description ........................................................................................... 13 4.2 Schedule of Events ............................................................................................. 13 4.3 Study Population ................................................................................................ 14 Inclusion Criteria ............................................................................. 14 Exclusion Criteria ............................................................................ 14 4.4 Definitions of Study Variables ........................................................................... 14 4.5 Data Collection .................................................................................................. 22 4.6 Conventions ....................................................................................................... 23 5. DATA QUALITY CONTROL AND ASSURANCE ................................................ 23 5.1 Quality Control .................................................................................................. 23 5.2 Audit from Quality Assurance Unit ................................................................... 24 5.3 Inspection by Institutional Review Board / Institutional Ethics Committee or Competent Authority ..................................................................................... 24 5.4 Data Management .............................................................................................. 25 5.5 Reports ............................................................................................................... 26 5.6 Plans for Disseminating and Communicating Study Results ............................ 26 5.7 Archiving of Study Documentation ................................................................... 26 6. PLANNED ANALYSES .............................................................................................. 28 6.1 Interim Analysis ................................................................................................. 28 6.2 Final Analysis .................................................................................................... 28 7. ANALYSIS SETS ......................................................................................................... 28 7.1 All Subjects Enrolled Set [ENR] ....................................................................... 28 7.2 Full Analysis Set [FAS] ..................................................................................... 29 7.3 Safety Analysis Set [SAF] ................................................................................. 29 PropertyDocument: of Takeda: Takeda_SAP_Vedolizumab For non-commercial-5045_v2.0_20181203.docx use only and subject to the applicable Terms of Use Author: PPD Version Number: 2.0 Version Date: 03 DEC 2018 CCI Page 5 of 45 Statistical Analysis Plan Template 8. STATISTICAL ANALYSIS........................................................................................ 30 8.1 General Considerations ...................................................................................... 30 8.2 Analysis Plan for Demographic and Clinic Characteristics ............................... 31 8.3 Analysis Plan for Clinical Data.......................................................................... 31 8.4 Analysis Plan for Laboratory and Endoscopic Data .......................................... 32 8.5 Analysis Plan for Treatment Data ...................................................................... 32 8.6 Statistical Tests and Confidence Intervals ......................................................... 33 8.7 Missing data ....................................................................................................... 33 8.8 Examination of Subgroups ................................................................................. 33 9. MEDICATIONS........................................................................................................... 33 10. STUDY OUTCOMES .................................................................................................. 34 10.1 Primary outcomes .............................................................................................. 34 Primary Outcome Variables ............................................................. 34 Primary Analysis of Primary Outcome Variables ........................... 34 10.2 Secondary Effectiveness .................................................................................... 35 Secondary Effectiveness Variables .................................................. 35 Analysis of Secondary Effectiveness Variables .............................. 36 10.3 Exploratory Effectiveness .................................................................................. 36 Exploratory Effectiveness Variables ................................................ 36 Analysis of Exploratory Effectiveness Variables ............................ 37 11. SAFETY OUTCOMES................................................................................................ 38 11.1 Definitions.......................................................................................................... 38 Adverse Event .................................................................................
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