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Covers study scope, study design, objectives, endpoints, and analysis set definitions, including criteria for eliminating data. Specifies planned statistical analyses for demographics, immunogenicity, and safety, plus procedures for interim analysis considerations, conduct of analyses, interpretation, and changes from planned analyses through final tables, listings, and figures.",{"@graph":69,"@context":123},[70,84,106],{"@type":71,"itemListElement":72},"BreadcrumbList",[73,77,79,82],{"item":74,"name":75,"@type":76,"position":8},"https://docshare.wps.com","Home","ListItem",{"item":78,"name":9,"@type":76,"position":14},"https://docshare.wps.com/document/",{"item":80,"name":40,"@type":76,"position":81},"https://docshare.wps.com/document/research-report/",3,{"item":83,"name":65,"@type":76,"position":19},"https://docshare.wps.com/document/statistical-analysis-plan-amendment-1-final/201711/",{"url":83,"name":65,"@type":85,"image":86,"author":91,"headline":65,"publisher":94,"fileFormat":97,"inLanguage":63,"description":67,"dateModified":98,"datePublished":99,"encodingFormat":97,"isAccessibleForFree":100,"interactionStatistic":101},"DigitalDocument",{"url":87,"@type":88,"width":89,"height":90},"https://docshare.wps.com/thumbnails/statistical-analysis-plan-amendment-1-final/201711.png","ImageObject",300,407,{"name":92,"@type":93},"Emma Mercer","Person",{"url":74,"name":95,"@type":96},"DocShare","Organization","application/pdf","2026-10-26","2026-09-04",true,{"@type":102,"interactionType":103,"userInteractionCount":105},"InteractionCounter",{"@type":104},"ViewAction",11,{"@type":107,"mainEntity":108},"FAQPage",[109,115,119],{"name":110,"@type":111,"acceptedAnswer":112},"What is the purpose of the Statistical Analysis Plan amendment 1?","Question",{"text":113,"@type":114},"It defines how immunogenicity and safety outcomes for study 204913 are to be analyzed and interpreted, including which data will be included or eliminated.","Answer",{"name":116,"@type":111,"acceptedAnswer":117},"Which analysis domains are covered in the planned statistical analyses?",{"text":118,"@type":114},"The plan includes analyses for demographics/baseline characteristics, immunogenicity, and safety, with further sub-sections for planned protocol analyses.",{"name":120,"@type":111,"acceptedAnswer":121},"How are analysis sets defined and what criteria eliminate data?",{"text":122,"@type":114},"It provides definitions for exposed and per-protocol sets and specifies criteria for eliminating data from each set, including elimination-related details.","https://schema.org",{"og:url":83,"og:type":125,"og:title":65,"og:site_name":95,"og:description":67},"article",{"robots":127,"canonical":83},"index,follow",{"doc_id":129,"site_id":62},201711,1790767804,{"code":4,"msg":5,"data":132},{"doc_id":129,"user_id":133,"nickname":92,"user_avatar":134,"doc_module":4,"category_id":39,"category_name":40,"doc_title":65,"doc_description":67,"doc_content":135,"file_id":136,"file_url":137,"file_type":138,"file_size":139,"view_count":105,"is_deleted":4,"is_public":8,"is_downloadable":8,"audit_status":8,"page_count":140,"language":141,"language_code":63,"site_id":62,"html_lang":63,"table_of_contents":142,"faqs":143,"seo_title":144,"seo_description":67,"update_tm":145,"read_time":146,"preview_page_count":4},962084925502,"https://ap-avatar.wpscdn.com/davatar_6f874abed73319feea01a86fa6f0fab8","204913 | Statistical Analysis Plan Amendment 1 24 Oct 2017 | TMF-847749 | 2.0  \nCONFIDENTIAL  \n204913 (NTHI-MCAT-006 EXT:001) Statistical Analysis Plan Final  \n\n| | Statistical Analysis Plan |\n| --- | --- |\n| Detailed Title: | A phase 1, multicentre, long term follow-up study up to 4 years after study vaccination to assess immunogenicity and safety of the investigational GSK Biologicals’GSK3277511A vaccine in adults. |\n| eTrack study number and Abbreviated Title | 204913 (NTHI-MCAT-006 EXT:001) |\n| Scope: | All data pertaining to the above study |\n| Date of Statistical Analysis Plan | Final: 24-OCT-2017 |\n| Co-ordinating author: | PPD  (Statistician), PPD \u003Cbr>(Statistician) |\n| Reviewed by: | PPD  (Clinical and Epidemiology Project Lead)\u003Cbr>PPD Lead) PPD\u003Cbr>PPD\u003Cbr>\u003Cbr>PPD\u003Cbr>PPD\u003Cbr>(Clinical Research and Development (Lead statistician)\u003Cbr>(Lead statistical analyst)(Scientific writer)\u003Cbr>(Safety Physician)\u003Cbr>\u003Cbr>\u003Cbr>\u003Cbr>|\n| Approved by: | PPD  (Clinical and Epidemiology Project Lead)\u003Cbr>PPD Lead) PPD\u003Cbr>PPD\u003Cbr>\u003Cbr>PPD\u003Cbr>(Clinical Research and Development (Lead statistician)\u003Cbr>(Lead statistical analyst)(Scientific writer)\u003Cbr>\u003Cbr>\u003Cbr>|\n\nAPP 9000058193 Statistical Analysis Plan Template (Effective date: 14April 2017)  \n24-OCT-2017 Page 1 of 22  \n204913 | Statistical Analysis Plan Amendment 1 24 Oct 2017 | TMF-847749 | 2.0  \nCONFIDENTIAL  \n204913 (NTHI-MCAT-006 EXT:001) Statistical Analysis Plan Final  \nTABLE OF CONTENTS  \nPAGE  \nLIST OF ABBREVIATIONS .............................................................................................6  \n1. DOCUMENT HISTORY ............................................................................................8  \n2. STUDY DESIGN ......................................................................................................8  \n3. OBJECTIVES ...........................................................................................................9  \n3.1. Primary objective ..........................................................................................9  \n3.2. Secondary objective .....................................................................................9  \n4. ENDPOINTS ............................................................................................................9  \n4.1. Primary endpoint...........................................................................................9  \n4.2. Secondary endpoints ....................................................................................9  \n5. ANALYSIS SETS ................................................................................................... 10  \n5.1. Definition..................................................................................................... 10  \n5.1.1. Exposed Set ................................................................................ 10  \n5.1.2. Per-protocol Set ........................................................................... 10  \n5.2. Criteria for eliminating data from Analysis Sets ........................................... 10  \n5.2.1. Elimination from Exposed Set ...................................................... 10  \n5.2.2. Elimination from Per-protocol analysis Set ................................... 11  \n5.2.2.1. Excluded subjects....................................................... 11  \n5.3. Important protocol deviation not leading to elimination from perprotocol cohort ............................................................................................ 12  \n6. STATISTICAL ANALYSES ..................................................................................... 13  \n6.1. Demography ............................................................................................... 13  \n6.1.1. Analysis of demographics/baseline characteristics planned in the protocol .............................................................................. 13  \n6.2. Immunogenicity...................................................","cbCaileHitWHDaI2","https://ap.wps.com/l/cbCaileHitWHDaI2","pdf",1192590,22,"English","# TABLE OF CONTENTS\n## LIST OF ABBREVIATIONS\n## 1. DOCUMENT HISTORY\n## 2. STUDY DESIGN\n## 3. OBJECTIVES\n## 3.1. Primary objective\n## 3.2. Secondary objective\n## 4. ENDPOINTS\n## 4.1. Primary endpoint\n## 4.2. Secondary endpoints\n## 5. ANALYSIS SETS\n## 5.1. Definition\n## 5.2. Criteria for eliminating data from Analysis Sets\n## 6. STATISTICAL ANALYSES\n## 6.1. Demography\n## 6.2. Immunogenicity\n## 6.3. Analysis of safety\n## 7. ANALYSIS INTERPRETATION\n## 8. CONDUCT OF ANALYSES\n## 9. CHANGES FROM PLANNED ANALYSES\n## 10. LIST OF FINAL REPORT TABLES, LISTINGS AND FIGURES\n## 11. ANNEX 1 STANDARD DATA DERIVATION RULE AND STATISTICAL METHODS","[{\"question\":\"What is the purpose of the Statistical Analysis Plan amendment 1?\",\"answer\":\"It defines how immunogenicity and safety outcomes for study 204913 are to be analyzed and interpreted, including which data will be included or eliminated.\"},{\"question\":\"Which analysis domains are covered in the planned statistical analyses?\",\"answer\":\"The plan includes analyses for demographics/baseline characteristics, immunogenicity, and safety, with further sub-sections for planned protocol analyses.\"},{\"question\":\"How are analysis sets defined and what criteria eliminate data?\",\"answer\":\"It provides definitions for exposed and per-protocol sets and specifies criteria for eliminating data from each set, including elimination-related details.\"}]","Statistical Analysis Plan - Amendment 1 - Final | PDF",1788537399,55]