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{ "answers": [ { "answer_end": [ 11, 11 ], "answer_start": [ 8, 10 ], "text": [ "Soft Drink Ingredient Series", "Ingredient Series" ] }, { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "SOFT DRINKS AND CAFFEINE" ] }, { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "SOFT DRINKS AND CAFFEINE" ] } ], "question": [ "What sort of document series does it covers ?", "What is the title of the series?", "What is the title of the document?" ], "question_id": [ 862, 864, 865 ] }
[ "ARRI1", "1987", "SOFTDRINKS", "AND", "CAFFEINE", ".", ".", "1", "Soft", "Drink", "Ingredient", "Series", "Source:", "https://www.industrydocuments.ucsf.edu/docs/pkpj0226" ]
null
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{ "answers": [ { "answer_end": [ 61 ], "answer_start": [ 55 ], "text": [ "Caffeine and Other Alleged Health Related Effects" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "PepsiCo, Inc., The Physical or Technical Effect of Caffeine in Cola Beverages, Purchase, N.Y., July 20, 1981" ] }, { "answer_end": [ 318 ], "answer_start": [ 316 ], "text": [ "University of Florida" ] }, { "answer_end": [ 54 ], "answer_start": [ 54 ], "text": [ "1983" ] } ], "question": [ "What is are the words written in bold in second paragraph?", "What is the second reference mentioned?", "Which university does the sixth reference mention?", "Which year is mentioned in the first reference?" ], "question_id": [ 912, 915, 917, 918 ] }
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{ "answers": [ { "answer_end": [ 42 ], "answer_start": [ 42 ], "text": [ "301/436-2373" ] }, { "answer_end": [ 15, 15 ], "answer_start": [ 12, 12 ], "text": [ "Food & Drug Administration", "FOOD & DRUG ADMINISTRATION" ] } ], "question": [ "What is the Telephone Number given?", "What is the fulll form of FDA?" ], "question_id": [ 898, 904 ] }
[ "JUL-03-2008", "10:26", "FDA/CFSAN/ONPLDS", "301", "436", "2639", "P.", "01", ".", ".", "FDA", "CFSAN", "FOOD", "&", "DRUG", "ADMINISTRATION", "CENTER", "FOR", "FOOD", "SAFETY", "&", "APPLIED", "NUTRITION", "OFFICE", "OF", "NUTRITIONAL", "PRODUCTS,", "LABELING", "&", "DIETARY", "SUPPLEMENTS", "(HFS-200)", "5100", "Paint", "Branch", "Parkway", "College", "Park,", "MD", "20740", "TELEPHONE", "NUMBER:", "301/436-2373", "FAX", "NUMBER:", "301/436-2636", "DATE:", "1/", "3", "/", "08", "TO:", "rickion", "FAX", "NUMBER:", "2020", "12", "-", "3", "31-", "2054", ".", "FROM:", "COMMENTS:", "..", ".", "..", ".", "..", ".", ".", ".", ".", ".", "Received", "07-03-2008", "11:07", "am", "From", "301", "436", "2639", "Page", "001", "Source:", "https://www.industrydocuments.ucsf.edu/docs/rxpj0226" ]
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{ "answers": [ { "answer_end": [ 74 ], "answer_start": [ 68 ], "text": [ "Center for Food Safety and Applied Nutrition" ] }, { "answer_end": [ 12 ], "answer_start": [ 7 ], "text": [ "DEPARTMENT OF HEALTH & HUMAN SERVICES" ] }, { "answer_end": [ 27 ], "answer_start": [ 26 ], "text": [ "Audrae Erickson" ] }, { "answer_end": [ 448 ], "answer_start": [ 448 ], "text": [ "07-03-2008" ] } ], "question": [ "What is the full form of CFSAN?", "Which department is mentioned in the letter head?", "Who is the President of Corn Refiners Association?", "When was this letter received?" ], "question_id": [ 899, 900, 901, 902 ] }
[ "HFCSF", "JUL-03-2008", "10:26", "FDA/CFSAN/ONPLDS", "301", "436", "2659", "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "College", "Park,", "MD", "20740", ".", ".'", "Audrae", "Erickson", "JUL", "0", "3", "2008", "President", "Com", "Refiners", "Association", "1701", "Pennsylvania", "Avenue,", "N.W.", "Suito", "950", "Washington,", "DC", "20006-5805", ":", "Dear", "Ms.", "Erickson:.", "This", "is", "in", "follow", "up", "to", "the", "meeting", "of", "April", "16,", "2008,", "between", "the", "Corn", "Refiners", "Association", "and", "the", "Center", "for", "Food", "Safety", "and", "Applied", "Nutrition", "(CFSAN).", "The", "meeting", "was", "prompted", "by", "a", "Food", "Navigator-[JSA.com", "article", "on", "the", "use", "of", "the", "term", "\"natural\"", "on", "products", "containing", "high", "fructose", "com", "syrup", "(HFCS).", "You", "asked", "CFSAN", "to", "reconsider", "its", "position", "on", "whether", "the", "use", "of", "the", "term", "\"natural\"", "can", "be", "used", "to", "describe", "products", "containing", "HFCS.", "At", "the", "meeting", "Mr.", "Empie", "of", "Archer", "Daniels", "Midland", "Company", "described", "the", "manufacturing", "process", "used", "to", "make", "HFCS", "and", "following", "the", "meeting", "you", "sent", "CFSAN", "a", "written", "description", "of", "this", "production", "process.", "During", "the", "meeting,", "we", "stated", "that", "our", "longstanding", "policy", "on", "the", "use", "of", "the", "term", "\"natural\"", "is", "that", "\"natural\"", "means", "that", "nothing", "artificial", "(including", "artificial", "flavors)", "or", "synthetic", "(including", "all", "color", "additives", "regardless", "of", "source)", "has", "been", "included", "in", "or", "has", "been", "added", "to", "a", "food", "that", "would", "not", "normally", "be", "expected", "to", "be", "in", "the", "food.", "Additionally,", "we", "stated", "that", "we", "do", "not", "restrict", "the", "use", "of", "the", "term", "\"natural\"", "except", "on", "products", "that", "contain", "added", "color,", "synthetic", "substances", "and", "flavors", "as", "provided", "for", "n", "Title", "21", "of", "the", "Code", "of", "Federal", "Regulations", "(CFR),", "section", "101.22.", "After", "reviewing", "the", "information", "about", "the", "HFCS", "production", "process", "that", "you", "provided,", "it", "is", "our", "understanding", "that", "the", "enzyme", "used", "to", "make", "HFCS", "is", "fixed", "to", "a", "column", "by", "the", "use", "of", "the", "synthetic", "fixing", "agent,", "glutaraldehyde.", "Any", "unreacted", "glutaraldehyde", "is", "removed", "by", "washing", "the", "column", "prior", "to", "the", "addition", "of", "the", "high", "dextrose", "equivalent", "com", "starch", "hydrolysate,", "which", "undergoes", "enzymatic", "reaction", "to", "produce", "HFCS.", "Because", "the", "glutaraldehyde", "does", "not", "come", "into", "contact", "with", "the", "high", "dextrose", "equivalent", "corn", "starch", "hydrolysate,", "it", "would", "not", "be", "considered", "to", "be", "included", "in", "or", "added", "to", "the", "HFCS.", "Therefore,", "we", "would", "not", "object", "to", "the", "use", "of", "the", "term", "\"natural\"", "on", "a", "product", "containing", "the", "HFCS", "produced", "by", "the", "manufacturing", "process", "described", "by", "Mr.", "Empie.", "However,", "we", "would", "object", "to", "the", "use", "of", "the", "term", "\"natural\"", "on", "a", "product", "containing", "HFCS", "that", "has", "a", "synthetic", "substance", "such", "as", "a", "synthetic", "fixing", "agent", "included", "in", "or", "added", "to", "it.", "We", "would", "also", "object", "to", "the", "use", "of", "the", "term", "\"natural\"", "on", "a", "product", "containing", "HFCS", "if", "the", "acids", "used", "to", "obtain", "the", "starch", "hydrolysate", "do", "not", "fit", "within", "our", "policy", "on", "\"natural\"", "as", "stated", "above.", ":", ".", ".", "Received", ".", "07-03-2008", ":11:07am", "From-301", "436", "2639", "Paga", "002", "Source:", "https://www.industrydocuments.ucsf.edu/docs/rxpj0226" ]
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null
1
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rxpj0226_1.png
1,689
2,280
{ "answers": [ { "answer_end": [ 6 ], "answer_start": [ 4 ], "text": [ "January 29, 2016" ] }, { "answer_end": [ 11, 13 ], "answer_start": [ 10, 10 ], "text": [ "Sandy Douglas", "Sandy Douglas, Coca-Cola Co." ] }, { "answer_end": [ 6 ], "answer_start": [ 4 ], "text": [ "January 29, 2016" ] } ], "question": [ "What is the date mentioned on the document?", "With whom is the meeting being conducted?", "What is the date mentioned in the header of the document?" ], "question_id": [ 924, 926, 929 ] }
[ "Coca", "-", "Cola", "F", "January", "29,", "2016", "MFJ", "meeting", "with", "Sandy", "Douglas,", "Coca-cola", "Co.", "Arti", "Arora,", "Senior", "Director", "Regulatory", "&", "Policy.", "Caren", "Pasquale", "Seckler,", "VP", "social", "commitment", "Jim", "O'Hara,", "CSPI", "He", "said", "that", "Coke", "has", "a", "five-point", "overall", "strategy:", "Shaping", "choice", "Innovation", "Clear", "facts", "(labeling?)", "Market", "responsibly", "(no", "logos", "on", "toys,", "etc.)", "Leading", "engagement", "(ABA's", "commitment", "to", "cut", "calories", "by", "20%)", "His", "main", "point", "was", "to", "explain", "Coke's", "One", "Brand", "marketing", "strategy,", "which", "means", "including", "all", "brands", "in", "each", "ad.", "This", "includes", "significant", "packaging", "redesign,", "e.g.,", "changing", "Diet", "Coke", "from", "silver", "with", "red", "trim", "to", "Coke", "red", "with", "silver", "trim.", "Indicated", "that", "this", "was", "going", "to", "happen", "for", "Coke", "Zero", "as", "well", "which", "is", "now", "black", "with", "red", "trim.", "Says", "it's", "a", "big", "deal.", "We", "shall", "see.", "His", "main", "point", "also", "was", "that", "Coke", "aims", "to", "reduce", "added", "sugars.", "It", "is", "making", "a", "big", "push", "to", "increase", "sales", "of", "7.5-", "to", "8.5-oz", "cans", "and", "bottles.", "He", "says", "they", "are", "higher", "priced", "now", "because", "relatively", "few", "bottlers", "have", "the", "ability", "to", "produce", "them,", "so", "shipping", "and", "other", "distribution", "costs", "are", "high.", "Coke", "wants", "to", "reduce", "the", "price", "differential.", "This", "faces", "significant", "hurdle", "with", "retailers", "who", "have", "relied", "on", "cheap", "soda", "as", "\"loss", "leader\".", "He", "hoped", "that", "the", "industry", "and", "health", "advocates", "could", "cooperate", "to", "push", "the", "moderation", "theme.", "And", "by", "industry,", "he", "meant", "the", "entire", "food", "and", "beverage", "industry,", "including", "supermarkets", "and", "restaurants.", "(I", "should", "talk", "with", "Larry", "Soler", "and", "others", "about", "that.)", "Moderation,", "he", "said,", "also", "represents", "a", "significant", "change", "in", "a", "40-year-old", "business", "model", "where", "one", "and", "all", "were", "rewarded", "by", "increasing", "unit", "volume.", "Focus", "now", "is", "on", "generating", "revenue", "rather", "than", "volume.", "He", "said", "that", "in", "a", "recent", "period", "of", "time", "only", "one", "in", "four", "Americans", "had", "had", "a", "Coke.", "If", "that", "number", "can", "be", "hiked", "to", "one", "in", "two", "Americans,", "then", "theoretically", "that", "can", "bring", "down", "the", "per", "capita", "consumption", "but", "still", "drive", "revenue", "increase.", "20%", "reduction", "in", "the", "UK", "from", "2015", "to", "2020", "(here", "is", "it", "20%", "by", "2025):", "He", "said", "that", "Britons", "believe", "EFSA's", "reassurances", "that", "aspartame", "is", "safe,", "whereas", "Americans", "don't", "believe", "U.S.", "government", "assurances.", "Apparently,", "Britons", "have", "been", "switching", "from", "full-calorie", "to", "diet", "soft", "drinks.", "Source:", "https://www.industrydocuments.ucsf.edu/docs/gxpj0226" ]
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null
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{ "answers": [ { "answer_end": [ 13, 13 ], "answer_start": [ 12, 12 ], "text": [ "Carbonated Water", "Carbonated water" ] }, { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "What's in Soft Drinks", "WHAT'S IN SOFT DRINKS" ] } ], "question": [ "what is the main ingredient of soft drink?", "What is the heading in right corner ?" ], "question_id": [ 910, 914 ] }
[ "ATRRI", "1", "9:87", "Soft", "drinks", "are", "simple", "products.", "The", "main", "ingredient", "is", "carbonated", "water.", "Other", "ingredients", "are", "identified", "-", ".", ".", "WHAT'S", "IN", "on", "the", "label", "in", "decreasing", "order", "of", "amount.", "The", "data", "included", "in", "this", "pamphlet", "SOFT", "are", "for", "those", "who", "want", "more", "detailed", "information.", "Values", "listed", "herein", "represent", "typical", "ranges", "for", "various", "DRINKS", "categories", "of", "major,", "nationally", "distributed", "brands", "of", "soft", "drinks.", "More", "information", "about", "any", "of", "these", "ingredients", "may", "be", "obtained", "from", "the", "National", "Soft", "Drink", "Association", "1101", "16th", "Street,", "N.W.", "..", "..", ".", "Washington,", "D.C.", "20036", "(202)", "463-6750", "National", "Soft", "Drink", "Association", "1101", "16th", "Street,", "N.W.", "Washington,", "D.C.", "20036", "12/86", "(202)", "463-6732", "Soft", "Drink", "Ingredient", "Series", "Source:", "https://www.industrydocuments.ucsf.edu/docs/pkpj02:26" ]
null
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pkpj0226_1.png
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{ "answers": [ { "answer_end": [ 1 ], "answer_start": [ 0 ], "text": [ "historical background" ] }, { "answer_end": [ 26 ], "answer_start": [ 18 ], "text": [ "coffee beans, tea leaves, kola nuts and cocoa beans" ] }, { "answer_end": [ 2 ], "answer_start": [ 2 ], "text": [ "caffeine" ] }, { "answer_end": [ 81, 81, 81 ], "answer_start": [ 78, 78, 80 ], "text": [ "Chinese emperor Shen nung", "chinese emperor shen nung", "Shen nung" ] }, { "answer_end": [ 119, 119 ], "answer_start": [ 118, 117 ], "text": [ "spanish conquerors", "the Spanish conquerors" ] } ], "question": [ "what is the title of the page?", "what are the common sources of caffeine consumed by humans?", "what is widely distributed naturally occuring substance found in more than 60 plant species throughout he world?", "who is traditionally attributed to legendary for the first written mention of a coffee containing beverage tea?", "who were treated to a sweetened chocolate drink by aztec emporer montezuma?" ], "question_id": [ 927, 930, 936, 940, 948 ] }
[ "Historical", "Background", "Caffeine", "is", "a", "widely-distributed,", "naturally-occurring", "substance", "found", "in", "more", "than", "60", "plant", "species", "throughout", "the", "world.", "Coffee", "beans,", "tea", "leaves,", "kola", "nuts,", "and", "cocoa", "beans", "are", "among", "the", "more", "common", "sources", "of", "caffeine", "con-", "sumed", "by", "humans.", "People", "the", "world", "over", "have", "enjoyed", "beverages", "made", "from", "these", "natural", "sources", "for", "thousands", "of", "years.", "Caffeine", "consumption", "dates", "back", "to", "prehistoric", "times.", "The", "first", "written", "men-", "tion", "of", "a", "caffeine-containing", "beverage,", "tea,", "is", "traditionally", "attributed", "to", "the", "legendary", "Chinese", "Emperor", "Shen", "Nung", "in", "2737", "B.C.", "Historians", "generally", "agree", "that", "coffee's", "consumption", "as", "a", "hot", "beverage", "dates", "from", "about", "1000", "A.D.", "and", "the", "coffee", "plant", "may", "have", "been", "cultivated", "in", "Ethiopia", "as", "early", "as", "575", "A.D.", "In", "1519,", "the", "Spanish", "Conquerors", "were", "treated", "to", "a", "sweetened", "chocolate", "drink", "by", "the", "Aztec", "Emperor", "Montezuma.", "Small", "amounts", "of", "caffeine", "have", "been", "used", "as", "a", "flavor", "component", "in", "cola", "and", "pepper", "soft", "drinks", "since", "they", "originated", "in", "the", "mid-1880's.1", "Caffeine", "in", "Soft", "Drinks", "Grocery", "shelves", "today", "offer", "a", "wide", "vari-", "ety", "of", "soft", "drinks,", "each", "one", "formulated", "to", "meet", "particular", "consumer", "taste", "preferences.", "Some", "soft", "drinks", "contain", "Source:", "https://www.industrydocuments.ucsf.edu/docs/pkpj0226" ]
null
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pkpj0226_3.png
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{ "answers": [ { "answer_end": [ 2 ], "answer_start": [ 2 ], "text": [ "78N-0158" ] }, { "answer_end": [ 16 ], "answer_start": [ 14 ], "text": [ "September 27, 1978" ] } ], "question": [ "What is the docket No?", "What is the date in document?" ], "question_id": [ 921, 925 ] }
[ "Docket", "No.", "78N-0158", "Food", "and", "Drug", "Administration", "Hearings", "on", "Food", "Labeling", "Washington,", "D.", "C.", "September", "27,", "1978", "Testimony", "of", "Agnes", "Molnar", "Nutritionist,", "Food", "Law", "Project", "Community", "Action", "for", "Legal", "Services", "335", "Broadway,", "NY", "10013", ".", ".." ]
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null
1
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null
null
xgpj0226_1.png
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2,296
{ "answers": [ { "answer_end": [ 24, 23 ], "answer_start": [ 23, 23 ], "text": [ "Carlton Curtis", "Carlton" ] }, { "answer_end": [ 29, 57, 0 ], "answer_start": [ 28, 55, 0 ], "text": [ "100th year", "its 100th year", "100" ] }, { "answer_end": [ 44 ], "answer_start": [ 42 ], "text": [ "April 23, 1985" ] }, { "answer_end": [ 98, 86, 142 ], "answer_start": [ 84, 84, 141 ], "text": [ "Roberto C. Goizueta, chairman of the Board and Chief executive officer of The Coca-Cola Company", "Roberto C. Goizueta", "Mr. Goizueta" ] } ], "question": [ "What is the name of the person mentioned to Contact?", "Which year is COCA-COLA beginning with a new taste?", "What is the date mentioned?", "Who said, \"The best has been made even better\"?" ], "question_id": [ 933, 934, 935, 937 ] }
[ "The", "Coca", "Cola", "Company", "Media", "Relations", "Department", "news", "P.O.", "Drawer", "1734,", "Allanta,", "Ga.", "30301", "Telephone", "(404)", "676-2121", "release", "FOR", "IMMEDIATE", "RELEASE", "Contact", ":", "Carlton", "Curtis", "404/676-2678", "COCA-COLA", "BEGINS", "100TH", "YEAR", "WITH", "A", "NEW", "TASTE;", "FIRST", "CHANGE", "EVER", "IN", "SECRET", "FORMULA", "NEW", "YORK,", "April", "23,", "1985", "--", "Coca-cola,", "the", "world's", "number", "one", "consumer", "product,", "will", "begin", "its", "100th", "year", "with", "a", "new", "taste,", "representing", "the", "first", "change", "in", "the", "secret", "formula", "since", "Coca-cola", "was", "created", "in", "1886.", "\"The", "best", "has", "been", "made", "even", "better,\"", "said", "Roberto", "C.", "Goizueta,", "chairman", "of", "the", "Board", "and", "chief", "executive", "officer", "of", "The", "Coca-cola", "Company.", "\"We", "have", "changed", "the", "taste", "of", "the", "most", "universally", "enjoyed", "consumer", "product", "around", "the", "world.", "\"Consumers", "in", "blind", "taste", "tests", "all", "across", "the", "continent", "have", "told", "us", "they", "prefer", "the", "new", "taste", "of", "Coca-cola", "to", "the", "original", "by", "an", "overwhelming", "majority,", "\"", "Mr.", "Goizueta", "said,", "\"and", "there", "is", "an", "even", "wider", "margin", "when", "consumers", "are", "told,", "'This", "is", "a", "new", "Coca-cola.", "'\"", "Mr.", "Goizueta", "added,", "\"", "Some", "may", "choose", "to", "call", "this", "the", "boldest", "single", "marketing", "move", "in", "the", "history", "of", "the", "packaged", "goods", "business.", "We", "simply", "call", "it", "the", "surest", "move", "ever", "made,", "because", "the", "new", "taste", "of", "Coke", "was", "shaped", "by", "the", "taste", "of", "the", "consumer", ".", "Source:", "https://www.industrydocu?tents", "cuntents.ucsf.edu/docs/lzyj0226" ]
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1
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996 ], [ 497, 980, 772, 998 ] ]
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null
lzyj0226_1.png
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{ "answers": [ { "answer_end": [ 31, 32 ], "answer_start": [ 31, 31 ], "text": [ "95", "95 years" ] }, { "answer_end": [ 40, 40 ], "answer_start": [ 38, 38 ], "text": [ "Feb. 4, 1982", "Feb 4, 1982" ] }, { "answer_end": [ 23, 23 ], "answer_start": [ 22, 22 ], "text": [ "Tony tortorici", "Tony Tortorici" ] } ], "question": [ "H ow many years of advertising is mentioned?", "What is the date mentioned?", "Whose name is mentioned to Contact?" ], "question_id": [ 938, 939, 942 ] }
[ "Coke", "Isit!", "news", "Coca", "Cola's", "Coker", "release", "COCA-COLA", "USA", "Public", "Relations", "Department", "P.O.", "Drawer", "1734.", "Atlanta.", "Ga.", "30301", "elephone", "(404)", "808-2121", "CONTACT:", "Tony", "Tortorici", "FOR", "IMMEDIATE", "RELEASE", "404/898-3696", "PAUSE", "TO", "REFLECT", "95", "YEARS", "OF", "ADVERTISING", "FOR", "COCA-COLA", "ATLANTA,", "Feb.", "4,", "1982", "--", "\"Coke", "is", "it!\"", "is", "the", "new", "advertising", "theme", "for", "Coca-cola", "and", "the", "descendant", "of", "a", "series", "of", "slogans", "which", "are", "as", "much", "a", "part", "of", "American", "life", "as", "Brand", "Coke", "itself.", "Unveiled", "this", "week", "at", "a", "Coca-cola", "USA", "Bottlers'", "meeting", "in", "Atlanta,", "\"Coke", "is", "it!\"", "is", "a", "bold", "concept", "which", "succeeds", "\"Have", "a", "Coke", "and", "a", "smile,", "\"", "the", "main", "advertising", "theme", "for", "the", "product", "since", "1979.", "The", "new", "theme", "breaks", "from", "tradition", "by", "placing", "more", "emphasis", "on", "the", "superiority", "of", "Coca-cola", "in", "taste,", "total", "refreshment", "and", "as", "thirst", "quencher.", "The", "direct,", "positive", "statement", "--", "\"Coke", "is", "it!\"", "--", "appeals", "to", "the", "forthright", "stance", "of", "Americans", "in", "the", "1980s.", "Throughout", "the", "history", "of", "Coca-cola,", "the", "Company's", "advertising", "has", "accurately", "reflected", "attitudes", "of", "the", "times,", "often", "anticipating", "changing", "lifestyles", "and", "the", "national", "temperament.", "Since", "1886,", "adver-", "tising", "for", "Coca-cola", "has", "portrayed", "fluctuations", "in", "social", "climate,", "structure,", "values", "and", "politics.", "AJT/RCW/1.", "19.9", "(more)", "Source:", "https://www.industrydocuments.ucsf.edu/docs/ztyj0226" ]
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null
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null
null
ztyj0226_1.png
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{ "answers": [ { "answer_end": [ 24 ], "answer_start": [ 23 ], "text": [ "Tony Tortorici" ] }, { "answer_end": [ 28 ], "answer_start": [ 28 ], "text": [ "404/898-3696" ] }, { "answer_end": [ 35 ], "answer_start": [ 29 ], "text": [ "BOTTLERS OF COCA-COLA LEAD SOFT DRINK INDUSTRY" ] }, { "answer_end": [ 157, 157 ], "answer_start": [ 156, 155 ], "text": [ "Coca-Cola Company", "The Coca-Cola Company" ] } ], "question": [ "Who is the contact person given in the document?", "What is the contact no of Tony Tortorici?", "What is the headline of the news release?", "Which company provides marketing and technical support at every stage of the operation?" ], "question_id": [ 50893, 50894, 50895, 50897 ] }
[ "Coke", "is", "ill", "news", "Coca", "Cola", "Cokey", "release", "COCA-COLA", "USA", "Public", "Relations", "Department", "P.O.", "Drawer", "1734.", "Atlanta,", "Ga.", "30301", "Telephone", "(404)", "898-2121", "CONTACT:", "Tony", "Tortorici", "FOR", "IMMEDIATE", "RELEASE", "404/898-3696", "BOTTLERS", "OF", "COCA-COLA", "LEAD", "SOFT", "DRINK", "INDUSTRY", "ATLANTA,", "Feb.", "4,", "1982", "--", "The", "2,000", "owners", "and", "executives", "of", "some", "550", "American", "bottlers", "gathered", "here", "to", "help", "launch", "the", "\"Coke", "is", "it!\"", "advertising", "campaign", "today", "are", "the", "heart", "of", "the", "Coca-cola", "system", "and", "the", "key", "to", "its", "continued", "leadership", "in", "the", "soft", "drink", "industry.", "From", "its", "beginnings", "at", "the", "turn", "of", "the", "century,", "the", "bottler", "system", "for", "Coca-cola", "has", "been", "primarily", "a", "local", "business", "--", "plants", "owned,", "managed", "and", "staffed", "locally", "and", "distributing", "within", "the", "home", "community.", "The", "local", "bottler", "buys", "syrup", "or", "concentrate", "for", "Coca-cola", "and", "other", "Company", "soft", "drinks", "from", "Coca-cola", "USA,", "produces", "the", "finished", "product,", "adds", "carbonated", "water", "in", "bottles", "or", "cans", "and", "distributes", "it", "to", "retail", "outlets", "to", "be", "sold", "to", "the", "public.", "The", "Coca-cola", "Company", "provides", "marketing", "and", "technical", "support", "at", "every", "stage", "of", "the", "operation.", "This", "commitment", "is", "renewed", "as", "the", "Company", "nears", "the", "beginning", "of", "its", "second", "hundred", "years", "with", "goals", "of", "continuing", "to", "surpass", "the", "industry's", "growth", "rate", "and", "to", "lead", "in", "every", "market", "segment", "--", "bottle", "and", "can,", "take-home", "and", "fountain.", "AJT/NAT/1.", "20.", "14", "(", "more)", "Source:", "https://www.industrydocuments.ucsf.edu/docs/ttyj0226" ]
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ttyj0226_1.png
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{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 0 ], "text": [ "Research & Development Organization Chart" ] }, { "answer_end": [ 14, 14 ], "answer_start": [ 9, 9 ], "text": [ "Dr. Claire Thom & Masatake Kashiyae", "Dr Claire Thom & Masatake Kashiyae" ] }, { "answer_end": [ 27, 27 ], "answer_start": [ 25, 25 ], "text": [ "Dr. John Page", "Dr John Page" ] } ], "question": [ "What is the heading", "who is VP, Research & Development", "who is Director,Safety" ], "question_id": [ 1655, 1656, 1657 ] }
[ "Research", "&", "Development", "Organization", "Chart", "VP,", "Research", "&", "Development", "Dr.", "Claire", "Thom", "&", "Masatake", "Kashiyae", "Safety", "n=25", "Or.", "Claire", "Thom", "Admin.", "Eileen", "Kuster", "Director,", "Safety", "Dr.", "John", "Page", "Admin.", "Lori", "Muhlenbeck", "Sr.", "Manager", "Clinical", "Safety", "Sr.", "Manager", "Dr.", "Connie", "Kasprzak", "Post", "Mktg.", "Safety", "Associate", "Director", "Medical", "Review", "Supervisor", "Dr.", "Doug", "Joseba", "10/02", "Data", "Coordination", "&", "Logistics", "Lisa", "Eck", "Sr.", "Clinical", "Safety", "Specialist", "Sri", "PM", "Safety", "Specialist", "Medical", "Safety", "Manager", ":Data", "Coordinator", "10702", "Judy", "Hopper", "Dr.", "Mondira", "Bhattacharya", "Awilda", "Colon", "Clinical", "Safety", "PM", "Sefer", "Medical", "Safety", "Reviewer", "Specialist", "Belly", "Rieckhoff", "Specialist", "Dr.", "Larissa", "Shotovskaya", "ata", "Coordinator", "Beverly", "Noonan", "Bonnie", "Blach", "fedical", "Safety", "Reviewer", "Clinical", "Safety", "Specialist", "PM", "Safety", "ert", "Dietz", ":Data", "Coordinator", "Mary", "Ann", "Casseday", "Michael", "Kim", "Medical", "Safety", "Reviewer", "Wande", "Mayfield", "$1/02", "finical", "Safe", "PM", "Safety", "Data", "Coordinator", "`Specialist.", "Speciallet", "Maria", "Esocobed", "Mary", "Gegenhub", "Data", "Coordinato", "Lois", "MacAdam", "Data", "Coordinator", "Gloria", "Saldana", "Last", "update", "OCT", "2002", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-00161947", "Produced", "in", "MDL", "on", "09/02/12", "Source:", "https://www.indupov45-oooents.ucsf.edu/docs/tljf0226" ]
null
null
7
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tljf0226_7.png
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{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 0 ], "text": [ "Research & Development Organization Chart" ] }, { "answer_end": [ 14 ], "answer_start": [ 9 ], "text": [ "Dr. Claire Thom & Masatake Kashiyae" ] }, { "answer_end": [ 53 ], "answer_start": [ 53 ], "text": [ "Pharmacokineticist" ] }, { "answer_end": [ 155 ], "answer_start": [ 154 ], "text": [ "OCT 2002" ] } ], "question": [ "What is the title of the chart ?", "Who is the VP of Research & Development?", "What is the job title of Dr. Dwain Tolbert?", "When is the document last updated?" ], "question_id": [ 50903, 50904, 50911, 50912 ] }
[ "Research", "&", "Development", "Organization", "Chart", "VP,", "Research", "&", "Development", "Dr.", "Claire", "Thom", "&", "Masatake", "Kashiyas", "Clinical", "Research", "n=60", "Dr.", "Claire", "Thom", "Leader,", "Clinical", "Research", "12/02", "n=", "12", "VP.", "Clinical", "Research", "Phase", "/P,", "Clinical", "Research", "DE.", "Aziz", "Karim", "Actos/", "MPDRAP", "IIIA", "Admin.", "Or.", "Affonso", "Poroz", "Dant", "Anetman", "|", "Phase", "I", "Site", "Mgr", "Candy", "Columbia", "Pharmacokineticist", "Da.", "Dwain", "Tolbert", "Program", "Mgr.", "Dawn", "Bradford", "Program", "Mgr", "08702", "Program", "Mgr.,", "Actos", "DM", "stephen", "Cichy", "Program", "Mgr.,", "Actos", "CV", "Bright", "isaacson", "Study", "Mgr.", "Judi", "Johnson", "Study", "Manager", "Study", "Manger", "Study", "Manager", "Haggle", "Kruege", "Penny", "Fleck", "Patrick", "Gallagher", "\"Study", "Manager", "Lisa", "Schwartz", "Study", "Manager", "Study", "Manager", "Jennifer", "Ryan", "Clement", "Popovici", "Study", "Manager", "Patricia", "Schwartz", "y.", "Manager", "Study", "Manager", "Margaret", "Slater", "Amy", "Hagaman", "Study", "Manager", "Jearme", "Mayer", "Study", "Manager", "study", "Manager", "Susan", "Weszt", "add", "Johnson", "rogram", "Mar,", "135", "Ximora", "Alcaide", "Assoc.", "Study", "Study", "Manager", "Manager", "MCC-135", "Mark", "Hogan", "Laurel", "Sindelar", "contract.", "Assoo.", "Study", "Mgr.", "Nancy", "Butter", "Program", "Mgr.,", "475", "Last", "update", "OCT", "2002", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-00161942", "Produced", "in", "MDL", "on", "09/02/12", "Source:", "https://www.indupov15", "00002", "ts.ucsf.edu/docs/tljf0226" ]
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{ "answers": [ { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "tpna news on behalf of tpna news", "TPNA News on behalf of tpna news" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "TPNA News on behalf of tpna news" ] }, { "answer_end": [ 29 ], "answer_start": [ 23 ], "text": [ "Important Takeda Legal Information Relating to Actos - 1st of 2" ] } ], "question": [ "From whom is this document", "Who is the sender of this email?", "What is the subject of this email?" ], "question_id": [ 1659, 1660, 1661 ] }
[ "From:", "TPNA", "News", "on", "behalf", "of", "tona", "news", "To:", "*Home", "Office", "Users;", "**", "*Field", "Users", "BCC:", "tonanewssent@takedapharm.com", "Sent:", "9/17/2003", "4:55:59", "PM", "EXHIBIT", "Subject:", "Important", "Takeda", "Legal", "Information", "Relating", "to", "Actos", "-", "ist", "of", "2", "ENGAD", "800-831-639", "42", "PLEASE", "READ", "THIS", "MESSAGE", "CAREFULLY", "TAK-RIM30b6-00000655", "As", "you", "know,", "Takeda", "is", "involved", "in", "a", "small", "number", "of", "lawsuits", "relating", "to", "ACTOS@", "(pioglitazone", "HCI).", "As", "a", "result", "of", "these", "lawsuits,", "all", "documents", "and", "materials", "that", "exist", "or", "continue", "to", "be", "developed", "pertaining", "to", "ACTOS@", "have", "been", "and", "continue", "to", "be", "subject", "to", "a", "litigation", "hold.", "This", "means", "that", "all", "documents,", "materials,", "and", "computer", "files", "(including", "e-mails,", "word", "processing", "documents,", "slides,", "etc.)", "falling", "into", "this", "category", "must", "continue", "to", "be", "maintained", "until", "you", "are", "informed", "otherwise,", "regardless", "of", "the", "typical", "document", "retention", "policy.", "This", "policy", "has", "been", "in", "place", "since", "the", "filing", "of", "the", "first", "lawsuit", "against", "Takeda", "pertaining", "to", "ACTOS@.", "For", "hard", "copy", "format", "document", "and", "materials", "recorded", "on", "disposable", "electronic", "storage", "media,", "such", "as", "documents,", "materials,", "information,", "paper,", "floppy", "discs,", "CDs,", "video", "or", "any", "other", "portable", "medium,", "you", "are", "reminded", "NOT", "to", "dispose", "of", "such", "material,", "and", "to", "continue", "to", "retain", "such", "material", "pursuant", "to", "your", "department's", "filing", "systems.", "For", "electronic", "management", "information,", "documents", "and", "materials", "in", "Takeda's", "electronic", "information", "management", "systems,", "including", "electronic", "records", "saved", "in", "your", "desktop", "computer,", "you", "are", "reminded", "that", "this", "material", "may", "NOT", "be", "deleted", "under", "any", "circumstances.", "To", "the", "extent", "that", "material", "exists", "both", "electronically", "and", "in", "any", "other", "format,", "all", "material", "is", "to", "be", "retained", "pursuant", "to", "your", "department's", "filing", "systems.", "Any", "records", "fitting", "the", "classifications", "set", "forth", "above", "that", "have", "been", "placed", "into", "storage", "are", "also", "not", "to", "be", "destroyed", "at", "any", "time.", "Although", "no", "new", "lawsuit", "has", "been", "filed", "for", "some", "time,", "it", "nonetheless", "seemed", "appropriate", "to", "remind", "all", "employees", "that", "you", "must", "continue", "to", "carefully", "maintain,", "and", "NOT", "throw", "away,", "all", "materials", "pertaining", "to", "ACTOS@", "until", "further", "notice.", "If", "you", "have", "any", "questions", "or", "need", "any", "assistance", "with", "respect", "to", "the", "retention", "of", "ACTOS@", "related", "documents,", "please", "contact", "Arnold", "D'", "Angelo", "in", "the", "Law", "Department", "at", "847-383-3450.", "Thank", "you", "for", "your", "continuing", "cooperation", "in", "this", "important", "matter.", "Confidential", "-", "Subject", "to", "Protective", "Order", "Source:", "https://www.indup53dqcoboots.ucsf.edu/docs/tqjf0226" ]
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{ "answers": [ { "answer_end": [ 1 ], "answer_start": [ 0 ], "text": [ "Response Document" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "α, γ" ] }, { "answer_end": [ 42, 42 ], "answer_start": [ 39, 39 ], "text": [ "urine electrolytes, osmolality, pH", "(urine electrolytes, osmolality, pH)" ] } ], "question": [ "What is the heading of the document?", "What are mixed with α, γ?", "What are the renal effects mentioned?" ], "question_id": [ 945, 946, 947 ] }
[ "Response", "Document", "o", "Introduction", "o", "ACTOS", "male", "rat", "data", "summary", "o", "Summary", "of", "presumed", "FDA", "data", "on", "mixed", "inhibitors", "o", "Hypothesis", "for", "mechanism", "of", "action", "of", "ACTOS", "in", "male", "rats", "o", "Cohen", "hypothesis", "revisited", "and", "updated", "o", "Renal", "effects", "(urine", "electrolytes,", "osmolality,", "PH)", "o", "Liver", "effects", "(urine", "protein", "composition)", "o", "PPAR", "agonism:", "a,", "y,", "mixed", "a,", "y", "o", "Possible", "roles", "in", "bladder", "carcinogenesis", "o", "Characterization", "of", "thiazolidinediones", "(pio", "vs.", "rosi)", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-0000076", "Source:", "https://www.indup537qcoooosts.ucsf.edu/docs/xsjf0226" ]
null
null
5
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null
null
xsjf0226_5.png
1,700
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{ "answers": [ { "answer_end": [ 3, 3 ], "answer_start": [ 1, 1 ], "text": [ "international litigation services", "INTERNATIONAL LITIGATION SERVICES" ] }, { "answer_end": [ 6 ], "answer_start": [ 4 ], "text": [ "CERTIFICATION OF TRANSLATION" ] }, { "answer_end": [ 133, 133 ], "answer_start": [ 132, 132 ], "text": [ "joseph thorpe", "Joseph Thorpe" ] } ], "question": [ "What is the fullform of ils?", "What type of certification is mentioned in this document?", "Who is the Managing Director of International Litigation Services, Inc?" ], "question_id": [ 870, 871, 872 ] }
[ "ls", "INTERNATIONAL", "LITIGATION", "SERVICES", "CERTIFICATION", "OF", "TRANSLATION", "International", "Litigation", "Services,", "a", "company", "specializing", "in", "international", "cases", "and", "foreign", "language", "document", "processing,", "certifies", "the", "following:", "International", "Litigation", "Services", "has", "retained", "a", "professional", "translator", "for", "the", "attached", "Japanese", "into", "English", "document.", "The", "document", "is", "referred", "to", "as:", "\"TAK-SEITAT-00061905P-0001\"", "I", "affirm", "that", "such", "translation", "has", "been", "prepared", "by", "a", "duly", "qualified", "translator,", "who", "has", "confirmed", "that", "such", "translation", "is,", "to", "the", "best", "of", "his/", "her", "knowledge", "and", "belief,", "a", "true", "and", "accurate", "translation", "in", "English", "of", "the", "corresponding", "Japanese", "document.", "I", "declare", "under", "the", "penalty", "of", "perjury", "that", "the", "forgoing", "is", "true", "and", "correct,", "Notwithstanding", "the", "foregoing", "affirmations,", "no", "liability", "is", "assumed", "for", "errors", "and", "omissions", "in", "the", "translation", "of", "the", "attached", "document.", "Executed", "on", "this", "6th", "day", "of", "October", "2013,", "in", "Aliso", "Viejo,", "California.", "Joeph", "thorpe", "Joseph", "Thorpe", "Managing", "Director", "International", "Litigation", "Services,", "Inc.", "International", "Uffigation", "Services", "Inc.", ">", "65", "Enterprise", ".", "Aliso", "Viejo,", "California", "32656", "Phone:", "828.313.4457", "s", "Fax:", "213.674.4191", ".", "info@STEAM.com", ".", "WWW.isTEAM.com", "NEW", "YORK", ".", "LOS", "ANGELES", ".", "LAS", "VEGAS", "*", "ORANGE", "COUNTY", "Source:", "https://www.indupsy$8coooosts.ucsf.edu/docs/tpjf0226" ]
null
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3
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{ "answers": [ { "answer_end": [ 3, 3, 0 ], "answer_start": [ 1, 1, 0 ], "text": [ "Jose f caro/am/lly", "Jose F Caro/AM/LLY", "Jose f caro" ] } ], "question": [ "who is the sender of this email" ], "question_id": [ 1665 ] }
[ "From:", "Jose", "F", "Caro/AM/LLY", "Sent:", "005", "8:51:07", "AM", "To:", "Steven", "M", "Paul/AM/LLY@Lilly", "CC:", "Subject:", "Jack", "R", "Tupman/AM/LLY@Lilly;", "Vince", "Mihalik/AM/LLY@Lilly;", "William", "W", "Chin/AM/LLY@Lilly", "Re:", "FW:", "|", "12.20.04", "|", "Eyetech", "gains", "$105M", "on", "Macugen", "approval;", "Pfizer", "pulls", "Celebrex", "ads", "Steve,", "The", "3", "PPARs", "that", "were", "in", "phase", "I'll", "have", "either", "died?", "(Takeda),", "are", "having", "difficulties", "(Astrazeneca),", "or", "have", "shown", "to", "be", "not", "better", "than", "the", "TZDs", "on", "body", "weight", "and", "edema", "(BMS's", "Muraglitazar).", "Naveglitazar", "is", "at", "the", "front", "now", "and", "has", "the", "potential", "of", "less", "increase", "in", "body", "weight", "than", "the", "TZDs.", "I", "like", "your", "idea", "of", "continuing", "the", "collaboration", "with", "Takeda", "on", "PPAR", "and", "have", "them", "help", "us", "to", "develop", "Naveglitazar.", "Jose", "Steven", "M", "Paul/AM/LLY", "12/20/2004", "12:33", "PM", "To", "Jack", "R", "Tupman/AM/LLY@Lilly,", "Jose", "F", "Caro/AM/LLY@Lilly,", "Vince", "Mihalik/AM/LLY@Lilly,", "William", "W", "Chin/AM/LLY@Lilly", "cc", "Subject", "Fw:", "|", "12.20.04", "|", "Eyetech", "gains", "$105M", "on", "Macugen", "approval;", "Pfizer", "pulls", "Celebrex", "ads", "Wonder", "if", "we", "can", "extend", "the", "Actos", "deal", "--", "in", "exchange", "for", "a", "PPAR", "collaboration", "around", "naveglitizar", "?", "Seems", "like", "their", "phase", "PPAR", "has", "died", "?", "Steve", "Steven", "M.", "Paul,", "M.D.", "Executive", "Vice", "President,", "Science", "and", "Technology", "President,", "Lilly", "Research", "Laboratories", "Eli", "Lilly", "and", "Company", "Lilly", "Corporate", "Center", "Indianapolis,", "IN", "46285", "Tel:", "(317)", "276-8799", "Fax:", "(317)", "277-1125", "Paul_Steven_M@Lilly.com", "---", "Forwarded", "by", "Steven", "M", "Paul/AM/LLY", "on", "12/20/2004", "12:31", "PM", "---", "FierceBiotech", "<editors@fiercebiotech.com>", "To", "paul_steven_m@lilly.com", "12/20/2004", "12:18", "PM", "CC", "Please", "respond", "to", "editors@fiercebiotech.com", "Subject", "|", "12.20.04", "|", "Eyetech", "gains", "$105M", "on", "Macugen", "approval;", "Pfizer", "pulls", "Celebrex", "ads", "EXHIBIT", "HOven#", "33", "5/1/13", "FierceBiotech", "December", "20,", "2004", "Sign", "up", "for", "free:", "www.fiercebiotech.com", "This", "week's", "sponsor", "is", "GoToMeeting.", "Online", "Meetings", "Made", "Easy", "Present,", "demo", "products", "and", "train", "online", "-", "in", "real", "time", "-", "with", "GoToMeeting.", "Reach", "clients", "and", "colleagues", "without", "leaving", "your", "office.", "You'll", "save", "time", "and", "money.", "Try", "it", "Free", "PLA-TAK-00020529", "Source:", "https://www.indupso#8cooooqts.ucsf.edu/docs/ptjf0226" ]
null
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1
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null
null
ptjf0226_1.png
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{ "answers": [ { "answer_end": [ 12 ], "answer_start": [ 10 ], "text": [ "johnston,Kendra; precurato-grubb, marti" ] }, { "answer_end": [ 26 ], "answer_start": [ 19 ], "text": [ "article in today's USA Today regarding Avandia hearing" ] }, { "answer_end": [ 2, 2, 173 ], "answer_start": [ 1, 1, 170 ], "text": [ "CHEN, GIGI", "chen, gigi", "gigi m. chen, MBA" ] }, { "answer_end": [ 17, 17 ], "answer_start": [ 15, 15 ], "text": [ "7/31/2007 11:48:09 AM", "7/31/2007 11:48:09 am" ] }, { "answer_end": [ 173, 0 ], "answer_start": [ 170, 0 ], "text": [ "gigi m. chen, MBA", "gigi m.chen" ] }, { "answer_end": [ 185 ], "answer_start": [ 185 ], "text": [ "716.725.7100" ] } ], "question": [ "who are in the cc?", "what is the \"subject\" of this letter?", "who is writing this letter?", "when was this letter sent?", "who is the premier sales representative ?", "What is the cellular number of Gigi M. Chen?" ], "question_id": [ 971, 976, 978, 979, 980, 7070 ] }
[ "From:", "Chen,", "Gigi", "To:", "\"DCC", "WXA", "Dist", "Buffalo,", "NY", "CC:", "Johnston,", "Kendra;", "Precurato-Grubb,", "Marti", "Sent:", "7/31/2007", "11:48:09", "AM", "subject", "Article", "in", "today's", "USA", "Today", "regarding", "Avandia", "hearing", "Attachments:", "FDA", "Advised..,", "printed", "in", "USA", "Today", "July", "31", "07.", "doc", "Hello", "Buffalo", "Team", "&", "Marti,", "In", "case", "you", "did", "not", "see", "this", "in", "your", "travels", "today.", ".", "please", "find", "aflached", "an", "article", "regarding", "the", "Avandia", "hearing", "in", "USA", "Today", "printed", "7/31/07", "(Today).", "Note", "the", "chart", "on", "the", "right", "hand", "side", "of", "the", "page", "stating", "\"side", "effects\"", "of", "TZD's.", "Jason,", "the", "article", "you", "sent", "all", "of", "us", "regarding", "the", "side", "effect", "of", "cancer", "was", "even", "listed!", "Obviously,", "not", "something", "we", "would", "bring", "up", "or", "mention", "on", "our", "sales", "calls", "but", "just", "something", "to", "be", "aware", "of", "in", "case", "it", "is", "mentioned", "out", "in", "the", "hell!", "Also", "note", "the", "last", "sentence", "of", "the", "article:", "\"Actos,", "the", "other", "drug", "in", "the", "same", "class", "as", "Avandia,", "does", "not", "appear", "to", "increase", "heart", "attack", "risk,", "he", "said\",", "referencing", "David", "Graham's", "comment!", "Hope", "everyone", "is", "doing", "well!", "Gigi", "Gigi", "M.", "Chen,", "MBA", "Premier", "Sales", "Representative", "Buffalo", "North", "East", ".877", "202.2720", "ext.", "14692", "cellular:", "716.725.7100", "PENGSD", "EASIER", "EXHIBIT", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-CHENGI-00001686", "P7141-00001", "Source:", "https://www.industrydocuments.ucsf.edu/docs/tzjf0226" ]
null
null
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null
null
tzjf0226_1.png
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{ "answers": [ { "answer_end": [ 93 ], "answer_start": [ 93 ], "text": [ "High" ] }, { "answer_end": [ 19, 19 ], "answer_start": [ 17, 17 ], "text": [ "fw: skb problems", "FW: SKB PROBLEMS" ] }, { "answer_end": [ 288 ], "answer_start": [ 288 ], "text": [ "9" ] }, { "answer_end": [ 288 ], "answer_start": [ 288 ], "text": [ "9" ] } ], "question": [ "What is the level of importance of the email send by Witte, Kimberly?", "What is the subject of the document?", "What is the EXHIBIT number mentioned?", "What is the exhibit no given in the document?" ], "question_id": [ 960, 961, 962, 963 ] }
[ "Nathaniel", "M", "Osbome", "08/06/99", "11:34", "AM", "Fo:", "Matthew", "W", "Beebe,", "Mitchell", "W", "Tull,", "Angela", "K", "Wade", "Subject:", "FW:", "SKB", "PROBLEMS", "fyi..nat", "-", "Forwarded", "by", "Nathaniel", "M", "Osbome/AM/LLY", "on", "08/06/99", "11:34", "AM", "----", "'Daly,", "Rich\"", "<rdaly", "@takedapharm.com>", "on", "08/06/99", "09:58:27", "AM", "To:", "\"Peters,", "Linda\"", "<LPeters", "cc:", "Nathaniel", "M", "Osborne,", "\"Orlando,", "Dan\"", "<dorlando,", "\"Blake,", "Bill\"", "<bblake", "V:", "SKB", "PROBLEMS", "Add", "this", "to", "the", "H&H", "conf", "call.", "ra", ">", ">", "From:", "---Original", "Message----\"", "Witte,", "Kimberly", "Sent", ":", ">", "To", ":", "Daly,", "Ric", "Friday,", "August", "06,", "1999", "9:26", "AM", "Cc:", "Graziano,", "Dave", ">", "Subject:", "PROBLEMS", ">", "Importance:", "High", ">", "Rich", "V", "V", "I", "am", "forwarding", "a", "message", "from", "Brian", "Chunn", "out", "of", "Champaign,", "IL.", "as", "though", "SKB", "is", "putting", "on", "some", "audio/teleconferences", "and", "giving", "out", "It", "seems", "incorrect", "information", "regarding", "Actos.", "The", "message", "from", "Brian", "is", ">", "self-explanatory.", "This", "is", "something", "that", "I", "wanted", "to", "bring", "to", "your", "attention", "to", "see", "if", "there", "is", "anything", "that", "we", "could", "do.", "I", "appreciate", "your", "VVVVVVVY", "attention", "to", "this", "as", "it", "is", "a", "big", "concern.", "call", "me", "if", "you", "have", "any", "questions.", "Thanks", "so", "much", "Rich!", "Please", "Kim", "Witte", "--Original", "Message--", "--", "VVVVVVVVVVY", "From:", "Chunn,", "Brian", "Sent", ":", "Thursday,", "August", "05,", "1999", "9:17", "PM", "To:", "Witte,", "Kimberly", "Subject:", "SKB", "PROBLEMS", "Hi", "Kim!", "I", "wanted", "to", "pass", "along", "a", "problem", "I", "came", "upon", "today", "while", "in", "Danville,", "IL.", "I", "was", "in", "Dr.", "Sadiq's", "office", "who", "is", "one", "of", "my", "big", "targets", "(9A)", "and", "we", "were", "discussing", "Actos.", "He", "proceeded", "to", "ask", "me", "if", "urinary", "bladder", "tumors", "were", "a", "problem", "with", "the", "FDA.", "(This", "is", "the", "Doctor", "who", "asked", "me", "a", "month", "ago", "if", ">", "Actos", "caused", "Urinary", "bladder", "cancer)", "Knowing", "this", "woulds", "come", "up", "I", "was", "prepared", "to", "discuss", "the", "portion", "of", "the", "PI", "on", "page", "9", "discussing", "tumors", ">", "found", "in", "rats,", "but", "no", "humans.", "When", "I", "asked", "where", "he", "had", "heard", "this", ">", "information,", "he", "proceeded", "to", "tell", "me", "it", "came", "from", "a", "Smith", "Kline", "Beecham", ">", "audio/tele", "conference.", "He", "mentioned", "the", "person", "he", "was", "discussing", "this", ">", "with", "mentioned", "that", "the", "tumors", "were", "why", "there", "was", "a", "delay", "in", "Actos", "coming", ">", "to", "market.", "I", "can't", "imagine", "this", "is", "fair", "balance.", "I", "am", "also", "running", "into", ">", "some", "smaller", "objections", "from", "Docs", "BEFORE", "I", "have", "even", "discussed", "Actos", "with", ">", "them.", "I'm", "not", "sure", "if", "these", "are", "also", "coming", "from", "SKB", "speakers", "or", "if", "it", ">", "is", "coming", "from", "the", "SKB", "reps", "locally.", "However,", "I", "do", "know", "the", "urinary", ">", "bladder", "tumor", "came", "from", "some", "form", "of", "an", "audio/tele", "conference", "from", "SKB.", "just", "need", "to", "find", "out", "if", "there", "is", "anything", "that", "can", "be", "done", "to", "stop", "their", "I", "PENGAD", "800-891-890", "EXHIBIT", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00008577", "Beebe", "11.12.13", "Source:", "https://www.indup58gooooonts.ucsf.edu/docs/tsjf0226" ]
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null
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tsjf0226_1.png
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{ "answers": [ { "answer_end": [ 133 ], "answer_start": [ 132 ], "text": [ "Joseph Thorpe" ] }, { "answer_end": [ 127 ], "answer_start": [ 123 ], "text": [ "28th day of August 2013" ] }, { "answer_end": [ 131, 131 ], "answer_start": [ 128, 129 ], "text": [ "In aliso Viejo, california", "Aliso Viejo, California" ] } ], "question": [ "who is the managing director of international litigation services ?", "When it executed?", "Where was the translation executed at?" ], "question_id": [ 944, 953, 955 ] }
[ "ils", "INTERNATIONAL", "LITIGATION", "SERVICES", "CERTIFICATION", "OF", "TRANSLATION", "International", "Litigation", "Services,", "a", "company", "specializing", "in", "international", "cases", "and", "foreign", "language", "document", "processing,", "certifies", "the", "following:", "International", "Litigation", "Services", "has", "retained", "a", "professional", "translator", "for", "the", "attached", "Japanese", "into", "English", "document.", "The", "document", "is", "referred", "to", "as:", "\"TAK-SEITAT-00111731P-0001\"", "I", "affirm", "that", "such", "translation", "has", "been", "prepared", "by", "a", "duly", "qualified", "translator,", "who", "has", "confirmed", "that", "such", "translation", "is,", "to", "the", "best", "of", "his/", "her", "knowledge", "and", "belief,", "a", "true", "and", "accurate", "translation", "in", "English", "of", "the", "corresponding", "Japanese", "document.", "I", "declare", "under", "the", "penalty", "of", "perjury", "that", "the", "forgoing", "is", "true", "and", "correct,", "Notwithstanding", "the", "foregoing", "affirmations,", "no", "liability", "is", "assumed", "for", "errors", "and", "omissions", "in", "the", "translation", "of", "the", "attached", "document.", "Executed", "on", "this", "28th", "day", "of", "August", "2013,", "in", "Aliso", "Viejo,", "California.", "Joseph", "Thorpe", "Managing", "Director", "International", "Litigation", "Services,", "Inc.", "International", "Uffigation", "Services", "Inc.", ">", "65", "Enterprise", ".", "Aliso", "Viejo,", "California", "32656", "Phone:", "828.313.4457", "s", "Fax:", "213.674.4191", ".", "info@isTEAM.com", ".", "www.TEAM.com", "NEW", "YORK", ".", "LOS", "ANGELES", ".", "LAS", "VEGAS", "*", "ORANGE", "COUNTY", "Source:", "https://www.indup3790", "0oosts.ucsf.edu/docs/zpjf0226" ]
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zpjf0226_3.png
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{ "answers": [ { "answer_end": [ 2 ], "answer_start": [ 1 ], "text": [ "Kanayama Kiyoshi" ] }, { "answer_end": [ 16 ], "answer_start": [ 11 ], "text": [ "Shephard, Kirk (TPI); Fuse, Touichirou (TPC)" ] }, { "answer_end": [ 174 ], "answer_start": [ 173 ], "text": [ "Kanayama_Kiyoshi@takeda.co.jp" ] }, { "answer_end": [ 29 ], "answer_start": [ 21 ], "text": [ "Re: Potential Publicaton in Correspondence Section of The Lancet" ] } ], "question": [ "From whom has this email been sent?", "Who are on the CC list?", "What is the email ID of Kanayama Kiyoshi?", "What is the subject of this email?" ], "question_id": [ 956, 957, 958, 959 ] }
[ "From:", "Kanayama", "Kiyoshi/B", "=", "40", "#jAPE", "To:", "Spanheimer,", "Robert", "CC:", "Sent:", "Shepard,", "Kirk", "(TPI);", "Fuse,", "Touichirou", "(TPC)", "10/27/2011", "5:14:48", "PM", "Subject:", "Re:", "Potential", "Publication", "in", "Correspondence", "Section", "of", "The", "Lance", "Dear", "Bob,", "Thank", "you", "for", "your", "response.", "Best,", "Kiyoshi", "On", "2011/10/27,", "at", "22:07,", "\"Spanheimer,", "Robert\"", "<bob.spanheimer@takeda.com>", "wrote:", "Dear", "Kiyoshi", "As", "noted", "below", "several", "letters", "were", "written", "to", "Lancet", "and", "the", "journal", "requested", "a", "response", "from", "the", "Proactive", "steering", "committee.", "The", "timeline", "for", "the", "response", "was", "short,", "I", "believe", "4-5", "days,", "and", "was", "to", "come", "from", "the", "Proactive", "steering", "committee.", "Because", "of", "the", "short", "timeline,", "the", "Proactive", "steering", "committee", "was", "contacted", "as", "well", "as", "key", "members", "of", "the", "Actos", "publication", "team", "to", "determine", "if", "we", "should", "respond,", "and", "then", "draft", "a", "response.", "The", "decision", "was", "we", "must", "respond,", "and", "Erland_Erdmann(Chair", "of", "the", "committee)", "John", "Dormandy", "(lead", "author", "on", "the", "original", "publication),", "and", "Massimo", "Massi-Benedetti", "(safety", "officer", "of", "Proactive)", "and", "I", "wrote", "the", "response", "letter.", "The", "GMST", "for", "Actos", "as", "well", "as", "Alphonso", "Perez", "the", "GDT", "lead", "were", "informed.", "Bob", "--.", ".", ".", "..", "From:", "Kanayama", "Kiyoshi@takeda.co.jp", "[mailto:Kanayama_Kiyoshi@takeda.co.jp]", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-SPANHR-00005674", "EXHIBIT", "(5", "DATE:", "/62", "22", "-13", "Juliana", "Zajicek", "CSR", "Source:", "https://www.indupsodoroooonts.ucsf.edu/docs/xtjf0226" ]
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xtjf0226_1.png
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{ "answers": [ { "answer_end": [ 2, 2 ], "answer_start": [ 0, 0 ], "text": [ "Flow for Approvals", "[Flow for Approvals]" ] } ], "question": [ "What is this flowchart about?" ], "question_id": [ 50919 ] }
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null
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null
null
hpjf0226_6.png
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{ "answers": [ { "answer_end": [ 14 ], "answer_start": [ 11 ], "text": [ "MGPS** data mining algorithm" ] } ], "question": [ "what algorithm is mentioned in Table 1 heading" ], "question_id": [ 1667 ] }
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null
null
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qnjf0226_10.png
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{ "answers": [ { "answer_end": [ 57 ], "answer_start": [ 57 ], "text": [ "tomorrow" ] }, { "answer_end": [ 35, 133 ], "answer_start": [ 35, 131 ], "text": [ "updated", "an updated version" ] }, { "answer_end": [ 19 ], "answer_start": [ 18 ], "text": [ "disproportionality report" ] } ], "question": [ "when will I be available for telecon if deemed necessary", "which version of disproportionality report was attached", "which report is mentioned in the subject" ], "question_id": [ 1668, 1669, 1670 ] }
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null
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{ "answers": [ { "answer_end": [ 268 ], "answer_start": [ 264 ], "text": [ "Senior Vice President, Accounting Center" ] } ], "question": [ "Who is the 23rd Addressee mentioned in the list?" ], "question_id": [ 972 ] }
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{ "answers": [ { "answer_end": [ 1, 1 ], "answer_start": [ 0, 0 ], "text": [ "Draft Agenda", "Draft Agenda?" ] }, { "answer_end": [ 5 ], "answer_start": [ 5 ], "text": [ "8:00-9:00" ] } ], "question": [ "Heading of the document?", "What are the timings for Continental Breakfast?" ], "question_id": [ 973, 975 ] }
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{ "answers": [ { "answer_end": [ 115 ], "answer_start": [ 115 ], "text": [ "32" ] }, { "answer_end": [ 46, 46 ], "answer_start": [ 39, 39 ], "text": [ "Re: Actos: Minutes from consultant meetings January 10th", "RE: Actos: Minutes from consultant meetings January 10th" ] } ], "question": [ "What is the Exhibit No mentioned in the document?", "What is the subject of the email form Paul A Hines?" ], "question_id": [ 50921, 50922 ] }
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{ "answers": [ { "answer_end": [ 398 ], "answer_start": [ 396 ], "text": [ "Mr. Hironao Ihara" ] }, { "answer_end": [ 408 ], "answer_start": [ 408 ], "text": [ "hironao.ihara@takeda.com" ] }, { "answer_end": [ 411 ], "answer_start": [ 411 ], "text": [ "702239" ] } ], "question": [ "Who is the Manager of MIS planning?", "What is the email id of Mr. Hironao Ihara?", "What is the IP phone no of Mr. Hironao Ihara?" ], "question_id": [ 50913, 50914, 50915 ] }
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{ "answers": [ { "answer_end": [ 2, 2 ], "answer_start": [ 2, 2 ], "text": [ "distribution", "Distribution" ] }, { "answer_end": [ 5, 5 ], "answer_start": [ 3, 3 ], "text": [ "JULY 19, 2002", "July 19, 2002" ] }, { "answer_end": [ 94, 94 ], "answer_start": [ 92, 92 ], "text": [ "MARLENE C. DUBAS", "Marlene C. Dubas" ] } ], "question": [ "Who is this Memo to?", "What is the date mentioned?", "Whose signature is present at the bottom?" ], "question_id": [ 964, 965, 966 ] }
[ "Memo", "to:", "Distribution", "July", "19,", "2002", "Page", "2", "Action", "Steps:", ".", "Please", "interpret", "this", "directive", "in", "its", "broadest", "sense", "to", "prevent", "the", "deletion", "or", "destruction", "of", "any", "recorded", "information", "and", "data", "relating", "in", "any", "way", "to", "Actos.", ".", "Please", "take", "steps", "immediately", "to", "preserve", "such", "documents", "and", "data", "within", "your", "department.", ".", "Please", "distribute", "this", "memo", "to", "members", "of", "your", "group", "and", "advise", "them", "of", "the", "importance", "of", "following", "these", "instructions.", "*", "*", "*", "*", "*", "If", "you", "have", "any", "questions", "regarding", "the", "implementation", "of", "this", "directive,", "please", "contact", "me", "Marlene", "Chulas", "Marlene", "C.", "Dubas", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000654", "Source:", "https://www.indup", "5309-ooo02ts.ucsf.edu/docs/sqjf0226" ]
null
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null
null
sqjf0226_2.png
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{ "answers": [ { "answer_end": [ 19 ], "answer_start": [ 11 ], "text": [ "RE: For your review: 5 Actos manuscripts for publications" ] }, { "answer_end": [ 201 ], "answer_start": [ 196 ], "text": [ "Thursday, March 13, 2008 9:21 AM" ] }, { "answer_end": [ 19 ], "answer_start": [ 12 ], "text": [ "For your review: 5 Actos manuscripts for publications" ] }, { "answer_end": [ 9 ], "answer_start": [ 7 ], "text": [ "3/13/2008 9:35:25 AM" ] } ], "question": [ "What is the subject of the email from Lannon, Mary-Margaret?", "What is the sent date and time of the email from Spanheimer, Robert?", "What is the subject of the email form Nakano, Takayuki (TGRD)?", "What is the sent date and time of the email from Lannon, Mary-Margaret?" ], "question_id": [ 50934, 50935, 50936, 50937 ] }
[ "From:", "To:", "Lannon,", "Mary-Margaret", "Spanheimer,", "Robert", "Sent", "3/13/2008", "9:35:25", "AM", "Subject:", "RE:", "For", "your", "review:", "5", "Actos", "manuscripts", "for", "publications", "EXHIBIT", "NO.", "2", "2", "10/23/13", "Oh", "yes,", "we", "have", "seen", "these", "-", "and", "we", "are", "not", "happy", "(and", "isn't", "it", "all", "about", "our", "happiness).", "The", "Erdmann", "one", "is", "actually", "a", "solicited", "review", "(not", "TPEU", "generated),", "and", "it", "is", "fine,", "even", "balanced.", "In", "fact,", "given", "the", "Erdmann", "review,", "they", "should", "cancel", "the", "CV", "risk", "and", "TZD", "manuscript", "(they", "should", "cancel", "it", "anyways", "given", "how", "embarrassingly", "unbalance", "it", "is).", "The", "Derosa", "manuscript", "is", "truly", "an", "independent", "review", "and", "I'm", "not", "sure", "we", "should", "even", "have", "our", "hands", "on", "it.", "There", "are", "no", "disclosure", "statements;", "they", "were", "all", "written", "by", "Susan's", "company,", "except", "the", "Derosa", "paper,", "and", "appear", "that", "way,", "so", "there", "is", "a", "little", "bit", "of", "a", "manuscript", "factory", "aspect", "to", "the", "group.", "The", "PROactive.", "..", "critical", "review,", "we", "saw", "very", "early", "on", "and", "then", "not", "again", "until", "now", "-", "lots", "of", "fun.", "That", "is", "probably", "more", "than", "you", "wanted", "to", "hear", "(remember,", "no", "good", "deed", "goes", "unpunished)", "Thanks", "for", "forwarding...", "and,", "most", "importantly,", "don't", "forget", "to", "fill", "out", "your", "brackets", "this", "weekend.", "MM", "From:", "Spanheimer,", "Robert", "Sent:", "Thursday,", "March", "13,", "2008", "9:21", "AM", "To:", "Lannon,", "Mary-Margaret", "Subject:", "FW:", "For", "your", "review:", "5", "Actos", "manuscripts", "for", "publications", "Mary-Margaret", "Just", "in", "case", "you", "have", "not", "seen.", "Bob", "From:", "Nakano,", "Takayuki", "(TGRD)", "Sent:", "Saturday,", "February", "23,", "2008", "5:52", "PM", "To:", "Perez,", "Alfonso", "(TGRD)", "Cc:", "Kupfer,", "Stuart;", "Spanheimer,", "Robert;", "Nishikata,", "Yukari", "(TPC);", "Nakano,", "Takayuki", "(TGRD)", "Subject:", "For", "your", "review:", "5", "Actos", "manuscripts", "for", "publications", "Alfonso,", "I", "am", "sending", "you", "five", "manuscripts", "that", "TPEU", "plans", "to", "submit", "to", "scientific", "journals", "for", "publications.", "Please", "review", "these", "and", "let", "us", "know", "your", "comments", "by", "Monday,", "March", "3.", "\"Pioglitazone", "and", "metformin", "fixed-dose", "combination", "in", "type", "2", "diabetes", "mellitus:", "an", "evidence-based", "review", "of", "its", "place", "in", "therapy\"", "for", "submission", "to", "\"Core", "Evidence\"", "<<File:", "Pio", "and", "Met", "FDC", "in", "T2D", "an", "evidence-based", "review", "of", "its", "place", "in", "therapy", "-", "Derosa", "(20Feb08).doc", ">>", "\"Thiazolidinediones", "and", "cardiovascular", "risk", "--", "a", "question", "of", "balance\"", "for", "submission", "to", "\"Cardiovascular", "Drug", "Reviews", "\"", "<<File:", "TZDsand", "CV", "risk", "-", "a", "question", "of", "balance", "-", "Erdmann", "(13Feb08).doc", ">>", "\"Cardiovascular", "risk", "and", "Thiazolidinediones", "-", "what", "do", "meta-analyses", "really", "tell", "us?\"", "for", "submission", "to", "\"Diabetologia\"", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-SPANHR-00002424", "Source:", "https://www.indup5063coboots.ucsf.edu/docs/ntjf0226" ]
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null
ntjf0226_1.png
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{ "answers": [ { "answer_end": [ 3 ], "answer_start": [ 1 ], "text": [ "International Litigation Services" ] }, { "answer_end": [ 134 ], "answer_start": [ 133 ], "text": [ "Joseph Thorpe" ] }, { "answer_end": [ 3 ], "answer_start": [ 1 ], "text": [ "INTERNATIONAL LITIGATION SERVICES" ] } ], "question": [ "who retained a professional translator", "who is the managing director of international litigation services,Inc.", "What is the fullform of ILS?" ], "question_id": [ 1671, 1673, 1674 ] }
[ "ils", "INTERNATIONAL", "LITIGATION", "SERVICES", "CERTIFICATION", "OF", "TRANSLATION", "International", "Litigation", "Services,", "a", "company", "specializing", "in", "international", "cases", "and", "foreign", "language", "document", "processing,", "certifies", "the", "following:", ".", "International", "Litigation", "Services", "has", "retained", "a", "professional", "translator", "for", "the", "attached", "Japanese", "into", "English", "document.", "The", "document", "is", "referred", "to", "as:", "\"TAK-NISHY-00221506P-0001\"", "I", "affirm", "that", "such", "translation", "has", "been", "prepared", "by", "a", "duly", "qualified", "translator,", "who", "has", "confirmed", "that", "such", "translation", "is,", "to", "the", "best", "of", "his/", "her", "knowledge", "and", "belief,", "a", "true", "and", "accurate", "translation", "in", "English", "of", "the", "corresponding", "Japanese", "document.", "I", "declare", "under", "the", "penalty", "of", "perjury", "that", "the", "forgoing", "is", "true", "and", "correct.", "Notwithstanding", "the", "foregoing", "affirmations,", "no", "liability", "is", "assumed", "for", "errors", "and", "omissions", "in", "the", "translation", "of", "the", "attached", "document.", "Executed", "on", "this", "19th", "day", "of", "February", "2014,", "in", "Aliso", "Viejo,", "California.", "Joeph", "thorpe", "Joseph", "Thorpe", "Managing", "Director", "International", "Litigation", "Services,", "Inc.", "International", "Litigation", "Services,", "Inc.", "&", "Of", "Enterprise", ".", "Aliso", "Viejo,", "California", "92656", "Phone:", "838", "313.4457", ".", "Fall", "2182.", "213.674.4181", ".", "Info@STEAM.com&WWW.HISTEAM.com", "NEW", "YORK", ".", "LOS", "ANGELES", ".", "LAS", "VEGAS", "*", "ORANGE", "COUNTY", "Source:", "https://www.industry-ments.ucsf.edu/docs/tfkf0226" ]
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9
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tfkf0226_9.png
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{ "answers": [ { "answer_end": [ 2, 2 ], "answer_start": [ 0, 0 ], "text": [ "Executive Summary, cont.", "executive summary, cont." ] }, { "answer_end": [ 5, 5 ], "answer_start": [ 4, 4 ], "text": [ "Proposed experiments", "proposed experiments" ] } ], "question": [ "what is the title of this page?", "what is the first point under the title-executive summary, cont." ], "question_id": [ 981, 983 ] }
[ "Executive", "Summary,", "cont.", "o", "Proposed", "experiments", "o", "Risk", "assessment", "for", "patients:", "o", "Are", "nongenotoxic", "rodent", "bladder", "tumorigens", "predictive", "of", "human", "risk?", "o", "Conclusions", "o", "Supplementary", "materials", "confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-0000076", "Source:", "https://www.indup537qcooocts.ucsf.edu/docs/xsjf0226" ]
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6
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xsjf0226_6.png
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{ "answers": [ { "answer_end": [ 1, 1 ], "answer_start": [ 0, 0 ], "text": [ "response document", "Response Document" ] } ], "question": [ "Heading of the document?" ], "question_id": [ 982 ] }
[ "Response", "Document", "o", "Experiments", "already", "undertaken", "o", "Proposal:", "high", "level", "\"executive\"", "summary", "o", "Stand", "alone", "o", "Bullet", "point", "organization", "o", "Supplementary", "material", "o", "Annotation", "of", "bullet", "points", "o", "Annotated", "references", "O>", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-0000076!", "Source:", "https://www.indup5379cooo04ts.ucsf.edu/docs/xsjf0226" ]
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4
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null
xsjf0226_4.png
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{ "answers": [ { "answer_end": [ 36, 36 ], "answer_start": [ 35, 35 ], "text": [ "Marlene Dubas", "marlene dubas" ] }, { "answer_end": [ 39, 39 ], "answer_start": [ 38, 38 ], "text": [ "Tom Muldoon", "tom muldoon" ] }, { "answer_end": [ 67 ], "answer_start": [ 58 ], "text": [ "Takeda Pharmaceuticals North America, Inc. and Takeda Pharmaceuticals America, Inc." ] }, { "answer_end": [ 49, 49 ], "answer_start": [ 41, 41 ], "text": [ "Preservation of Documents and Electronic Data relating to Actos", "preservation of documents and electronic data relating to actos" ] } ], "question": [ "who is writing this letter?", "who is in the cc?", "Which all compaies are added as defendants in a lawsuit?", "what is 'RE' in the letter?" ], "question_id": [ 990, 992, 998, 1001 ] }
[ "Takeda", "PENGAD", "800-431-698", "EXHIBIT", "40", "TO:", "Sam", "Hamanaka", "DATE:", "July", "19,", "2002", "Mark", "Booth", "Wendell", "Cheatham", "Rich", "Daly", "Terry", "Fukumoto", "Dean", "Hart", "Masatake", "Kashiyae", "Curtis", "Rhine", "Lori", "Smith", "Claire", "Thom", "Lee", "Voight", "Chuck", "Whitmer", "FROM:", "Marlene", "Dubas", "CC:", "Tom", "Muldoon", "RE:", "Preservation", "of", "Documents", "And", "Electronic", "Data", "relating", "to", "Actos", "MEMO:", "A", "motion", "has", "been", "filed", "to", "add", "Takeda", "Pharmaceuticals", "North", "America,", "Inc,", "and", "Takeda", "Pharmaceuticals", "America,", "Inc.", "as", "defendants", "in", "a", "lawsuit.", "The", "plaintiff", "in", "this", "lawsuit", "seeks", "damages", "for", "personal", "injury", "and", "wrongful", "death", "allegedly", "resulting", "from", "the", "use", "of", "certain", "prescription", "drugs,", "including", "Actos", "To", "be", "able", "to", "respond", "to", "discovery", "requests", "from", "the", "plaintiff,", "if", "that", "becomes", "necessary,", "we", "must", "take", "steps", "to", "preserve", "any", "documents", "that", "may", "be", "called", "for", "in", "this", "lawsuit.", "Until", "further", "notice,", "you", "are", "instructed", "to", "preserve", "any", "and", "all", "documents", "and", "electronic", "data", "which", "discuss,", "mention,", "or", "relate", "to", "Actos.", "This", "means", "do", "not", "destroy,", "delete,", "throw", "away", "or", "otherwise", "discard", "any", "such", "documents", "or", "electronic", "data.", "This", "includes", "correspondence,", "records,", "and", "data,", "contained", "in", "your", "paper", "and", "electronic", "files,", "regardless", "of", "form", "and", "including", "email", "correspondence", "and", "attachments", "and", "electronic", "data.", "Continued", ".", ".", ".", ".", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000653", "Source:", "https://www.indupt5309cooverits.ucsf.edu/docs/sqjf0226" ]
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null
1
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{ "answers": [ { "answer_end": [ 21 ], "answer_start": [ 18 ], "text": [ "Food and Drug Administration" ] }, { "answer_end": [ 42 ], "answer_start": [ 40 ], "text": [ "January 3, 2003" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "Jena Weber" ] }, { "answer_end": [ 310 ], "answer_start": [ 310 ], "text": [ "1" ] } ], "question": [ "What is the full form of FDA?", "What is the date mentioned?", "Who is the sender of this fax?", "What is the total no of pages in the fax including cover?" ], "question_id": [ 987, 989, 993, 994 ] }
[ "Received", "17", "3703", "1:16PM:", "3014439282", "REGULATORY", "AFFAIRS;", "31/03/03", "16:13", "DMEDP-CDER-FDA", "+", "8473833143'", "Page", "NO.", "006", "PO01/002", "EXHIBIT", "FDA", "Food", "and", "Drug", "Administration", "105", "Center", "for", "Drug", "Evaluation", "#", "PENGAD", "800-631-6989", "Office", "of", "Drug", "Evaluation", "ODE", "II", "FACSIMILE", "TRANSMITTAL", "SHEET", "DATE:", "January", "3,", "2003", "To:", "Janet", "Haskins", "From:", "Jona", "Weber", "Regulatory", "Manager", "Project", "Manager", "Company:", "Takeda", "Pharmaosuticals", "North", "Division", "of", "Metabolic", "and", "Endocrine", "Drug", "America,", "Inc.", "Products,", "HFD-510", "FAX", "number:", "847-383-3143", "Fax", "Autobor:", "301-443-9282", "Phone", "number:", "847-383-3243", "Phone", "number:", "301-827-6422", "Subject:", "Reference", "NDA", "21-073", "(Actos);", "labeling", "change", "to", "PRECAUTIONS", "section,", "Carcinogenesis,", "Mutagenesis,", "Impairment", "of", "Fertility", "subsection", "of", "the", "package", "insert", "as", "recommended", "by", "executive", "Carcinogenicity", "Assessment", "Committee", "(cCAC),", "convened", "December", "17,", "2002.", "Total", "no.", "of", "pages", "including", "cover:", "Comments", "-", "Committee", "Concludons:", "Data", "from", "the", "2-year", "rat", "caroinogenicity", "studies", "with", "several", "PPAR", "agonists", "demonstrate", "this", "class", "of", "compounds", "is", "clearly", "associated", "with", "marked", "increases", "in", "the", "incidence", "of", "bladder", "and/or", "renal", "epithelial", "cell", "tumors", "In", "rate", "of", "both", "sexes.", "The", "available", "mechanistic", "studies", "have", "failed", "to", "correlate", "the", "tumors", "in", "rats", "with", "changes", "in", "urine", "pi,", "osmolarity,", "changes", "in", "electrolyte", "concentrations,", "microcrystalluria", "or", "calculi.", "The", "Committee", "concluded", "these", "data", "suggest", "a", "potential", "clinical", "safety", "concern", "and", "agrees", "with", "the", "Division's", "recommendation", "for", "a", "proposed", "labeling", "change", "as", "follows:", "A", "two-year", "carcinogenicity", "study", "was", "conducted", "in", "male", "and", "female", "rats", "at", "oral", "doses", ".", "up", "to", "63", "mg/kg", "(approximately", "14", "times", "the", "maximum", "recommended", "human", "oral", "dose", "of", "45", "mg", "based", "ou", "ma/in", "').", "Drug-induced", "tumors", "were", "not", "observed", "in", "any", "organ", "except", "for", "the", "urinary", "bladder.", "Benign", "and/or", "malignant", "transitional", "cell", "neoplasms", "were", "observed", "in", "mile", "rats", "at", "4", "mg/kg/day", "and", "above", "(approximately", "equal", "to", "the", "maximum", "recommended", "human", "oral", "dose", "based", "on", "my/mo", "').", "The", "rolecountis", "of", "these", "findings", "in", "mais", "study", "was", "conducted", "in", "male", "and", "female", "mice", "at", "oral", "doses", "A", "two-year", "carcinogenicity", "up", "to", "100", "mg/kg/day", "(approximately", "1", "1", "times", "the", "maximum", "recommended", "human", "oral", "dose", "based", "on", "mam", "*).", "No", "drug-induced", "turnors", "were", "observed", "in", "iny", "organ.", "Document", "to", "be", "malled:", "O", "YES", "NO", "THIS", "DOCUMENT", "IS", "INTENDED", "ONLY", "FOR", "THE", "USE", "OF", "THE", "PARTY", "TO", "WHOM", "IT", "IS", "ADDRESSED", "AND", "MAY", "CONTAIN", "INFORMATION", "THAT", "18", "PRIVILEGED,", "CONFIDENTIAL,", "AND", "PROTECTED", "FROM", "DISCLOSURE", "UNDER", "APPLICABLE", "LAW,", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "JAN", "0", "3", "2003", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032194", "Source:", "https://www.indup5370-courts.ucsf.edu/docs/hsjf0226", "Dreduced", "in", "MMI", "an", "09/21" ]
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{ "answers": [ { "answer_end": [ 181 ], "answer_start": [ 181 ], "text": [ "3127154" ] }, { "answer_end": [ 206 ], "answer_start": [ 205 ], "text": [ "sgourley@sidley.com" ] }, { "answer_end": [ 214 ], "answer_start": [ 214 ], "text": [ "36088" ] } ], "question": [ "What is the IL Bar No. of Sara J. Gourley?", "What is the email id of Sara J. Gourley?", "What is the MO Bar No. of Scott W. Sayler?" ], "question_id": [ 50926, 50928, 50929 ] }
[ "client", "privilege,", "and", "other", "applicable", "privileges.", "Takeda", "further", "objects", "on", "the", "ground", "that", "this", "interrogatory,", "particularly", "subpart", "b,", "seeks", "the", "production", "of", "patient", "identifying", "information", "that", "Takeda", "is", "prohibited", "from", "disseminating", "pursuant", "to", "FDA", "regulations,", "HIPPA,", "and", "other", "applicable", "laws", "protecting", "patient", "privacy.", "Subject", "to", "and", "without", "waiving", "these", "or", "any", "other", "objection,", "Takeda", "directs", "Plaintiffs", "to", "Attachment", "A.", "Responding", "further,", "Takeda", "states", "that", "a", "general", "Actos@", "\"product", "liability\"", "litigation", "hold", "was", "implemented", "at", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "(f/k/a", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.)", "and", "Takeda", "Pharmaceuticals", "America,", "Inc.", "in", "July", "2002", "when", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "(f/k/a", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.)", "and", "Takeda", "Pharmaceuticals", "America,", "Inc.", "received", "notice", "of", "the", "first", "Actos@", "personal", "injury", "lawsuit,", "which", "was", "filed", "by", "Plaintiff", "Elizabeth", "McMillan", "in", "the", "Circuit", "Court", "of", "Jackson", "County,", "Missouri.", "The", "general", "Actos@", "\"product", "liability\"", "litigation", "hold", "became", "applicable", "to", "Takeda", "Development", "Center", "Americas,", "Inc.", "(f/k/a", "Takeda", "Global", "Research", "&", "Development", "Center,", "Inc.)", "at", "the", "time", "of", "its", "incorporation", "in", "2004", "and", "has", "been", "refreshed", "periodically", "since", "that", "time.", "Dated:", "August", "7,", "2013", "(Sara", "J.", "Gourley", "(IL", "Bar", "ND).", "3+37154)", "Sherry", "A.", "Knutson", "(IL", "Bar", "No.", "6276306)", "SIDLEY", "AUSTIN", "LLI", "1", "South", "Dearborn", "Street", "Chicago,", "IL", "60603", "(313)", "853-7000", "(Telephone)", "(312)", "853-7036", "(Facsimile)", "sgourley", "@sidley.com", "sknutson@sidley.com", "Scott", "W.", "Sayler", "(MO", "Bar", "No.", "36088)", "Rebecca", "J.", "Schwartz", "(MO", "Bar", "No.", "46341)", "SHOOK,", "HARDY", "&", "BACON,", "LLP", "2555", "Grand", "Boulevard", "Kansas", "City,", "MO", "64106", "(816)", "474-6550", "(Telephone)", "4", "P7071-00005", "PLA-TAK-00061865", "Source:", "https://www.industrydocuments.ucsf.edu/docs/Izjf0226" ]
null
null
5
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null
lzjf0226_5.png
1,701
2,201
{ "answers": [ { "answer_end": [ 1 ], "answer_start": [ 0 ], "text": [ "SIXTH OBJECTION" ] }, { "answer_end": [ 66 ], "answer_start": [ 65 ], "text": [ "Patrick Hanna" ] }, { "answer_end": [ 273 ], "answer_start": [ 273 ], "text": [ "3" ] }, { "answer_end": [ 61 ], "answer_start": [ 59 ], "text": [ "July 25, 2013" ] } ], "question": [ "Heading of the first paragraph?", "Name of the judge?", "What is the page no mentioned in this document?", "When was the hearing before Judge?" ], "question_id": [ 1002, 1003, 1004, 1005 ] }
[ "SIXTH", "OBJECTION", "Takeda", "objects", "to", "the", "extent", "that", "the", "Interrogatory", "seeks", "information", "or", "material", "pertaining", "to", "alleged", "side", "effects", "or", "adverse", "reactions", "to", "Actos@", "other", "than", "those", "of", "the", "character", "allegedly", "experienced", "by", "plaintiffs", "on", "the", "ground", "that", "such", "information", "is", "not", "relevant", "to", "any", "claim", "or", "defense", "involved", "in", "this", "action.", "RESPONSE", "Supplemental", "Interrogatory", "No.", "2:", "During", "a", "July", "25,", "2013", "hearing", "before", "Judge", "Patrick", "Hanna", "counsel", "of", "Defendants", "advised", "the", "court", "that", "\"claims,", "settlements", "and", "litigation\"", "had", "been", "made", "during", "a", "timeframe", "as", "early", "as", "2002", "concerning", "personal", "injuries", "relating", "to", "Actos.", "For", "these", "claims,", "please", "provide:", "a.", "Date(s)", "of", "the", "personal", "injury", "claims", "made", "relating", "to", "Actos;", "b.", "Identity", "of", "party", "or", "parties", "bringing", "or", "making", "the", "personal", "injury", "claims;", "c.", "Location", "of", "where", "these", "personal", "injury", "claims", "were", "brought", "or", "made", "and", "which", "Takeda", "entities", "they", "were", "brought", "or", "made", "against", "d.", "Court", "or", "other", "authority", "or", "agency", "charged", "with", "adjudicationg", "these", "personal", "injury", "claims;", "e.", "Identity", "of", "the", "lawyers", "and", "law", "firms", "representing", "Takeda", "in", "these", "personal", "injury", "claims", "from", "inception", "to", "the", "present", "day;", "F.", "Date(s)", "of", "any", "litigation", "hold(s)", "put", "in", "place", "for", "these", "personal", "injury", "claims;", "g.", "Current", "status", "of", "these", "personal", "injury", "claims;", "h.", "If", "these", "claims", "have", "been", "resolved,", "how", "they", "were", "resolved;", "and", "i.", "If", "they", "were", "resolved,", "when", "were", "they", "resolved?", "Response:", "In", "addition", "to", "the", "General", "Objections,", "Takeda", "objects", "to", "Supplemental", "Interrogatory", "No.", "2,", "including", "all", "of", "its", "subparts,", "on", "the", "following", "grounds:", "(1)", "is", "overly", "broad", "and", "unduly", "burdensome;", "(2)", "it", "seeks", "information", "that", "is", "not", "relevant", "and", "not", "reasonably", "calculated", "to", "lead", "to", "the", "discovery", "of", "admissible", "evidence;", "(3)", "it", "is", "vague", "and/or", "ambiguous;", "and", "(4)", "it", "calls", "for", "the", "production", "of", "information", "protected", "from", "discovery", "by", "the", "work", "product", "doctrine,", "the", "attorney-", "w", "P7071-00004", "PLA-TAK-00061864", "Source:", "https://www.industrydocuments.ucsf.edu/docs/Izjf0226" ]
null
null
4
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855, 546, 873 ], [ 550, 855, 575, 873 ], [ 579, 855, 616, 874 ], [ 620, 855, 681, 874 ], [ 684, 855, 750, 874 ], [ 753, 855, 778, 874 ], [ 781, 855, 851, 874 ], [ 491, 922, 507, 931 ], [ 446, 965, 539, 980 ], [ 795, 956, 942, 970 ], [ 230, 980, 296, 997 ], [ 299, 980, 771, 997 ] ]
null
null
lzjf0226_4.png
1,701
2,237
{ "answers": [ { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "takeda", "Takeda" ] }, { "answer_end": [ 0, 4 ], "answer_start": [ 0, 0 ], "text": [ "takeda", "TAKEDA PHARMACEUTICALS NORTH AMERICA, INC." ] }, { "answer_end": [ 109 ], "answer_start": [ 109 ], "text": [ "847-383-3427" ] } ], "question": [ "What is written in the image?", "Which pharmaceutical company is mentioned in the document?", "What is Fax number of 'Takeda Pharmaceuticals' ?" ], "question_id": [ 50940, 50946, 50954 ] }
[ "TAKEDA", "PHARMACEUTICALS", "NORTH", "AMERICA,", "INC.", "We", "understand", "that", "until", "we", "reach", "resolution", "of", "our", "ongoing", "discussion", "regarding", "the", "rat", "bladder", "findings,", "the", "Division", "is", "concerned", "about", "the", "use", "of", "ACTOS", "in", "pediatric", "patients.", "Therefore,", "we", "reconfirm", "our", "commitment", "to", "suspend", "pediatric", "studies.", "Should", "these", "discussions", "not", "assuage", "the", "Agency's", "concerns,", "the", "written", "request", "can", "be", "rescinded", "at", "a", "later", "date.", "We", "also", "reconfirm", "our", "commitment", "to", "resolving", "our", "differences", "with", "respect", "to", "the", "interpretation", "of", "the", "rat", "bladder", "findings.", "We", "look", "forward", "to", "discussing", "these", "issues,", "preferably", "in", "a", "face-to-face", "meeting,", "at", "your", "earliest", "convenience.", "Sincerely,", "Janet", "L.", "Haskins", "Manager,", "Regulatory", "Affairs", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "847-383-3243", "(Telephone)", "847-383-3427", "(Fax)", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "illinois", "60069", "Phone:", "847-383-3000", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00015504", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupizzo200002ts.ucsf.edu/docs/tyjf0226" ]
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null
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null
null
tyjf0226_2.png
1,709
2,243
{ "answers": [ { "answer_end": [ 354 ], "answer_start": [ 352 ], "text": [ "Janet L. Haskins" ] }, { "answer_end": [ 378 ], "answer_start": [ 378 ], "text": [ "847-383-3243" ] } ], "question": [ "What is the name of the sponsor or sponsor's authorized representative given in the application?", "What is the telephone no of Janet L. Haskins?" ], "question_id": [ 50941, 50944 ] }
[ "12.", "CONTENTS", "OF", "APPLICATION", "This", "application", "contains", "the", "following", "items:", "(Check", "all", "that", "apply)", "1.", "Form", "FDA", "1571", "(21", "CFR", "312.23(a)(1)]", "2.", "Table", "of", "Contents", "(21", "CFR", "312.23(a)(2)", "3.", "Introductory", "statement", "/21", "CFR", "312.23(a)(3)]", "4.", "General", "Investigational", "plan", "(21", "CFR", "312.23(a)(3)]", "5.", "Investigator's", "brochure", "[21", "CFR", "312.23(a)(5)]", "[]", "6.", "Protocol(s)", "[21", "CFR", "312.23(a)(6)]", "[", "a.", "Study", "protocol(s)", "(21", "CFR", "312.23(a)(6)]", "1080", "b.", "Investigator", "data", "[21", "CFR", "312.23(a)(6)(ili)(b)]", "or", "completed", "Form(s)", "FDA", "1572", "c.", "Facilities", "data", "(21", "CFR", "312,23(a)(6)(fil)(b)]", "or", "completed", "Form(s)", "FDA", "1572", "O", "d.", "Institutional", "Review", "Board", "data", "(21", "CFR", "312.23(a)(6)(ifi)(b)]", "or", "completed", "Form(s)", "FDA", "1572", "7.", "Chemistry,", "manufacturing,", "and", "control", "data", "(21", "CFR", "312.23(a)(7)", "Environmental", "assessment", "or", "claim", "for", "exclusion", "(21", "CFR", "312.23(a)(7)(iv)(e)]", "8.", "Pharmacology", "and", "toxicology", "data", "[21", "CFR", "312.23(a)(8)]", "9.", "Previous", "human", "experience", "(21", "CFR", "312.23(@)(9)]", "[]", "10.", "Additional", "information", "(21", "CFR", "312.23(a)(10)]", "13.", "IS", "ANY", "PART", "OF", "THE", "CLINICAL", "STUDY", "TO", "BE", "CONDUCTED", "BY", "A", "CONTRACT", "RESEARCH", "ORGANIZATION?", "O", "YES", "ONO", "F", "YES,", "WILL", "ANY", "SPONSOR", "OBLIGATIONS", "BE", "TRANSFERRED", "TO", "THE", "CONTRACT", "RESEARCH", "ORGANIZATION?", "O", "YES", "NO", "IF", "YES,", "ATTACH", "A", "STATEMENT", "CONTAINING", "THE", "NAME", "AND", "ADDRESS", "OF", "THE", "CONTRACT", "RESEARCH", "ORGANIZATION,", "IDENTIFICATION", "OF", "THE", "CLINICAL", "STUDY,", "AND", "A", "LISTING", "OF", "THE", "OBLIGATIONS", "TRANSFERRED.", "14.", "NAME", "AND", "TITLE", "OF", "THE", "PERSON", "RESPONSIBLE", "FOR", "MONITORING", "THE", "CONDUCT", "AND", "PROGRESS", "OF", "THE", "CLINICAL", "INVESTIGATIONS", "N/A", "15.", "NAME(S)", "AND", "TITLE(S)", "OF", "THE", "PERSON(S)", "RESPONSIBLE", "FOR", "REVIEW", "AND", "EVALUATION", "OF", "INFORMATION", "RELEVANT", "TO", "THE", "SAFETY", "OF", "THE", "DRU", "N/A", "I", "agree", "not", "to", "begin", "clinical", "Investigations", "until", "30", "days", "after", "FDA's", "receipt", "of", "the", "IND", "unless", "I", "receive", "earlier", "notification", "by", "FDA", "that", "the", "studies", "may", "begin.", "I", "also", "agree", "not", "to", "begin", "or", "continue", "clinical", "investigations", "covered", "by", "the", "IND", "if", "those", "studies", "are", "placed", "on", "clinical", "hold.", "I", "agree", "that", "an", "Institutional", "Review", "Board", "(IRB)", "that", "complies", "with", "the", "requirements", "set", "fourth", "in", "21", "CFR", "Part", "56", "will", "be", "responsible", "for", "Initial", "and", "continuing", "review", "and", "approval", "of", "each", "of", "the", "studies", "In", "the", "proposed", "clinical", "Investigation.", "I", "agree", "to", "conduct", "the", "Investigation", "in", "accordance", "with", "all", "other", "applicable", "regulatory", "requirements.", "16.", "NAME", "OF", "SPONSOR", "OR", "SPONSOR'S", "AUTHORIZED", "REPRESENTATIVE", "Janet", "L.", "Haskins", "18.", "ADDRESS", "(Number,", "Street,", "City,", "Stats", "and", "Zip", "Code)", "19/", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "20.", "DATE", "475", "Half", "Day", "Road,", "Suite", "500", "84/7-383-3243", "11/1/02", "Lincolnshire,", "IL", "60069", "(WARNING:", "A", "willfully", "faise", "statement", "is", "a", "criminal", "offense.", "U.S.C.", "Title", "18,", "Sec.", "1001.)", "Public", "reporting", "burden", "for", "this", "collection", "of", "information", "is", "estimated", "to", "average", "100", "hours", "per", "response,", "including", "the", "time", "for", "reviewing", "instructions,", "searching", "existing", "data", "sources,", "gathering", "and", "maintaining", "the", "data", "needed,", "and", "completing", "reviewing", "the", "collection", "of", "information.", "Send", "comments", "regarding", "this", "burden", "estimate", "or", "any", "other", "aspect", "of", "this", "collection", "of", "information,", "including", "suggestions", "for", "reducing", "this", "burden", "to", "Food", "and", "Drug.", "Administration", "\"An", "agency", "may", "not", "conduct", "or", "sponsor,", "and", "a", "CBER", "(HFM-99)", "Food", "and", "Drug", "Administration", "CDER", "(HFD-94)", "erson", "is", "not", "required", "to", "respond", "to,", "a", "1401", "Rockville", "Pike", "Rockville,", "MD", "20852-1448", "12229", "Wilkins", "Avenue", "Rockville,", "MD", "20852", "collection", "of", "information", "unless", "it", "displays", "a", "currently", "valld", "OMB", "control", "number.\".", "Please", "DO", "NOT", "RETURN", "this", "application", "to", "this", "address.", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "2", "OF", "2", "PSC", "Modis", "Arts", "Branch", "(301)", "443-1090", "BF", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00015506", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indup2292-00004ts.ucsf.edu/docs/tyjf0226" ]
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null
tyjf0226_4.png
1,705
2,240
{ "answers": [ { "answer_end": [ 11 ], "answer_start": [ 11 ], "text": [ "2002/07/24" ] }, { "answer_end": [ 22 ], "answer_start": [ 20 ], "text": [ "Novo Nordisk A/S" ] }, { "answer_end": [ 375 ], "answer_start": [ 372 ], "text": [ "Urinary microcrystallines or calculi" ] }, { "answer_end": [ 356 ], "answer_start": [ 355 ], "text": [ "Dr. Odaka" ] }, { "answer_end": [ 443 ], "answer_start": [ 443 ], "text": [ "MDL" ] }, { "answer_end": [ 445 ], "answer_start": [ 445 ], "text": [ "09/14/12" ] } ], "question": [ "What is the date on the document?", "On 22 July 2002, who announced that it had decided to suspend the clinical development of its dual-acting insulin sensitizer ragaglitazar (NN622)?", "What will be found in the carcinogenicity study of NN622 in rats?", "Who will find that NN622 has inhibitory effects on carbonic anhydrase as well as actos?", "Where was it produced in?", "When was it produced?" ], "question_id": [ 50540, 50542, 50543, 50544, 50545, 50546 ] }
[ "Comments", "on", "urinary", "bladder", "tumors", "occurred", "in", "carcinogenicity", "studies", "of", "NN622", "2002/07/24", "Drug", "Safety", "Research", "Labs", "On", "22", "July", "2002,", "Novo", "Nordisk", "A/S", "announced", "that", "it", "has", "decided", "to", "suspend", "the", "clinical", "development", "of", "its", "dual-acting", "insulin", "sensitizer", "ragaglitazar", "(NN622).", "All", "current", "clinical", "trials", "involving", "ragaglitazar", "have", "been", "stopped", "and", "all", "planned", "new", "clinical", "trials", "have", "been", "postponed,", "while", "preliminary", "data", "from", "preclinical", "studies", "in", "rats", "and", "mice", "are", "being", "investigated", "further.", "Novo", "Nordisk's", "decision", "was", "taken", "in", "response", "to", "findings", "of", "urinary", "bladder", "tumors", "in", "one", "mouse", "and", "a", "number", "of", "rats", "treated", "with", "ragaglitazar", "(see", "the", "following", "Website", "for", "details).", "http://www.novonordisk.com/opencms/03_Investors/SEA/English/020722_0.html?cmsframe=content", "Though", "the", "detailed", "information", "is", "not", "available", "yet,", "the", "findings", "of", "urinary", "bladder", "tumors", "in", "NN622", "seem", "to", "be", "similar", "to", "those", "in", "Actos.", "In", "case", "of", "Actos,", "TAKEDA", "had", "conducted", "several", "supplemental", "studies", "and", "has", "shown", "the", "hypothesis", "that", "multiple", "doses", "of", "Actos", "may", "change", "urinary", "nature", "(PH,", "ion", "concentrations,", "osmolarity", "and", "so", "on)", "leading", "to", "development", "of", "microcrystallines", "or", "calculi", "which", "can", "cause", "damage", "and", "regeneration", "of", "the", "bladder", "epithelium", "resulting", "in", "hyperplasia", "and", "tumors", "in", "the", "bladder", "epithelium", "in", "rats.", "These", "urinary", "changes", "and", "tumorigenic", "response", "of", "the", "urinary", "bladder", "are", "specific", "to", "rodent,", "in", "particular", "rats,", "and", "probably", "have", "no", "relevance", "for", "other", "species", "including", "humans.", "It", "is", "noteworthy", "that", "Actos", "and", "its", "metabolites", "are", "not", "genotoxic", "and", "have", "not", "direct", "proliferative", "effects", "on", "the", "bladder", "epithelium.", "FDA-CDER", "thinks", "that", "our", "hypothesis", "is", "plausible", "but", "not", "fully", "acceptable", "(see", "the", "Website", "for", "details).", "http://www.fda.gov/cder/foi/nda/99/021073A_Actos.htm", "In", "addition,", "it", "is", "well", "known", "that", "carbonic", "anhydrase", "inhibitors", "such", "as", "acetazolamide", "can", "develop", "microcrystallines", "or", "calculi", "by", "changing", "urinary", "pH", "resulting", "in", "urinary", "bladder", "hyperplasia", "and", "tumors", "in", "rodents", "(not", "in", "human).", "Actos", "and", "its", "metabolite", "M-V", "have", "weak", "inhibitory", "effects", "on", "carbonic", "anhydrase", "in", "the", "kidney", "and", "urinary", "bladder.", "We", "thought", "that", "this", "inhibitory", "effect", "of", "Actos", "may", "be", "involved", "in", "the", "mechanism", "of", "the", "urinary", "bladder", "tumor,", "but", "Dr.", "Cohen,", "who", "wrote", "\"White", "Paper\"", "for", "Actos", "as", "an", "expert", "of", "this", "area,", "had", "negative", "impression", "about", "its", "involvement.", "An", "effect", "of", "NN622", "on", "carbonic", "anhydrase", "will", "be", "checked", "soon", "by", "Dr.", "Odaka", "(Pharmacology", "Research", "Division).", "We", "now", "have", "both", "optimistic", "and", "pessimistic", "views", "as", "follows:", "[Optimistic", "views]", "Urinary", "microcrystallines", "or", "calculi", "will", "be", "found", "in", "the", "carcinogenicity", "study", "of", "NN622", "in", "rats.", "Dr.", "Odaka", "will", "find", "that", "NN622", "has", "inhibitory", "effects", "on", "carbonic", "anhydrase", "as", "well", "as", "Actos.", "Novo", "Nordisk", "will", "think", "the", "same", "hypothesis", "as", "ours.", "There", "will", "be", "no", "bladder", "tumors", "in", "a", "carcinogenicity", "study", "of", "TAK-559", "in", "rats", "(to", "be", "necropsied", "on", "July,", "2003).", "2002/7/24", "DSRL", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019813", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indup", "2298-ooouts.ucsf.edu/docs/zyjf0226" ]
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1
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null
null
zyjf0226_1.png
1,701
2,237
{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "January 14, 1999" ] }, { "answer_end": [ 10 ], "answer_start": [ 7 ], "text": [ "ELI LILLY AND COMPANY" ] }, { "answer_end": [ 31, 31 ], "answer_start": [ 30, 30 ], "text": [ "Extended Disability", "extended disability" ] } ], "question": [ "What is the date mentioned?", "What is the company name ?", "Which benefit start after 1 year of service?" ], "question_id": [ 1037, 1041, 1228 ] }
[ "Dr.", "Tan", "January", "14,", "1999", "Page", "5", "ELI", "LILLY", "AND", "COMPANY", "COMPENSATION", "AND", "BENEFITS", "PROGRAM", "(CONTINUED)", "Additional", "Company", "Benefits", "Medical", "and", "Dental", "Insurance", "Prescription", "Drug", "Benefits", "Reimbursement", "Accounts", "Illness", "Pay", "Extended", "Disability", "(Eligibility", "begins", "after", "1", "year", "of", "service)", "Credit", "Union", "Moving", "Plan", "(see", "enclosed", "brochure)", "Retirement", "Plan", "Employee", "Health", "Services", "Employee", "Activities", "Educational", "Assistance", "Program", "Savings", "Plan", "Holiday", "and", "Vacation", "Plan", "Please", "refer", "to", "the", "\"Employee", "Compensation\"", "booklet", "for", "the", "details.", "Optional", "Employee-Paid", "Benefits", "Supplemental", "Life", "Insurance", "Dependent", "Life", "Insurance", "Flexible", "CarePlus", "(life/long-term", "care", "insurance)", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-TANM-PF-00000050", "Source:", "https://www.indup6330-00005", "ts.ucsf.edu/docs/ttjf0226" ]
null
null
5
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null
null
ttjf0226_5.png
1,700
2,236
{ "answers": [ { "answer_end": [ 16 ], "answer_start": [ 14 ], "text": [ "August 16, 1999" ] }, { "answer_end": [ 19, 17 ], "answer_start": [ 17, 17 ], "text": [ "Alan D. Mackenzie", "Alan" ] }, { "answer_end": [ 29, 29, 28 ], "answer_start": [ 26, 26, 26 ], "text": [ "Takeda Pharmaceuticals America, Inc.", "Takeda Pharmaceuticals America Inc.", "Takeda Pharmaceuticals America" ] }, { "answer_end": [ 66 ], "answer_start": [ 56 ], "text": [ "Takeda Pharmaceuticals America, Inc. (\"TPA\") and Eli Lilly and Company (\"Lilly\")" ] } ], "question": [ "What is the date mentioned?", "To whom is this letter addressed?", "What is the full form of TPA?", "Which two companies have agreed to amend the Co-Promotion Agreement?" ], "question_id": [ 1043, 1045, 1046, 1048 ] }
[ "Lilly", "Eli", "Lilly", "and", "Company", "Pharmaceutical", "Division", "Lilly", "Corporate", "Center", "Indianapolis,", "Indiana", "46285", "317.276.2090", "August", "16,", "1999", "Alan", "D.", "Mackenzie", "Senior", "Vice", "President,", "Sales", "and", "Marketing", "Takeda", "Pharmaceuticals", "America,", "Inc.", "175", "Half", "Day", "Road", "Suite", "500", "Lincolnshire,", "IL", "60069", "RE:", "Amendment", "#1", "to", "Co-Promotion", "Agreement", "Dear", "Alan:", "This", "letter", "will", "set", "forth", "the", "terms", "under", "which", "Takeda", "Pharmaceuticals", "America,", "Inc.", "(\"TPA\")", "and", "Eli", "Lilly", "and", "Company", "(\"Lilly\")", "have", "agreed", "to", "amend", "the", "Co-Promotion", "Agreement", "between", "TPA", "and", "Lilly", "dated", "December", "14,", "1998", "(the", "\"Agreement\").", "As", "we", "have", "agreed,", "in", "addition", "to", "the", "500", "sales", "representatives", "required", "under", "Section", "2.04(A)", "of", "the", "Agreement,", "Lilly", "will", "retain", "an", "additional", "255", "Lilly", "sales", "representatives", "for", "the", "period", "October", "1,", "1999", "through", "September", "30,", "2000,", "with", "a", "preference", "for", "utilizing", "full", "time", "Lilly", "employees", "rather", "than", "a", "contracted", "sales", "force.", "The", "additional", "sales", "force", "will", "promote", "ACTOSTM", "in", "first", "detail", "position", "and", "PROZACS", "or", "another", "Lilly", "product", "in", "second", "detail", "position,", "and", "will", "target", "mid-decife", "primary", "care", "physicians.", "In", "consideration", "of", "the", "above", "facts,", "the", "parties", "agree", "to", "amend", "the", "Agreement", "as", "follows;", "1.", "The", "reimbursement", "cap", "for", "the", "details", "above", "the", "Lilly", "Actos", "Target", "Detail", "Level,", "as", "currently", "reflected", "in", "Sections", "2.04(A)", "and", "(C),", "shall", "be", "raised", "to", "1.", "1", "million", "(rather", "than", "800,000", "plus", "25%%,", "i.e.,", "1", "million)", "for", "the", "term", "October", "1,", "1999", "through", "September", "30,", "2090", "only.", "Takeda", "will", "reimburse", "Lilly", "$75", "for", "each", "Primary", "Detail", "made", "by", "the", "Lilly", "Diabetes", "Care", "sales", "force", "and", "each", "Actos", "detail", "made", "by", "the", "additional", "Lilly", "primary", "care", "sales", "force", "(said", "sales", "force", "described", "above),", "provided", "the", "number", "of", "total", "details", "(oum", "of", "Diabetes", "Care", "sales", "force", "Primary", "Details", "and", "additional", "primary", "care", "sales", "force", "Actos", "details)", "from", "October", "1,", "1999", "through", "September", "30", "2000", "is", "at", "least", "equal", "to", "seventy-two", "percent", "(72%%)", "of", "the", "1.1", "million", "cap.", "The", "remainder", "of", "the", "terms", "shall", "remain", "the", "same.", "2", "This", "amendment", "shall", "change", "the", "terms", "of", "the", "Agreement", "only", "for", "the", "period", "October", "1,", "1999", "through", "September", "30,", "2000.", "On", "October", "1,", "2000,", "the", "original", "terms", "of", "the", "Agreement,", "including", "but", "not", "limited", "to", "the", "reimbursement", "cap", "as", "reflected", "in", "Sections", "2.04(A)", "and", "(C),", "shall", "be", "automatically", "reinstated", "and", "operational", "with", "no", "further", "action", "required", "by", "either", "party.", "Amendment", "The", "parties", "hereby", "ratify", "the", "Agreement,", "which", "shall", "continue", "in", "full", "force", "and", "effect", "as", "modified", "by", "this", "EXHIBIT", "Pamfilantial", ".", "Quimiant", "in", "Oratactiva", "Ardor", "TAK", "TAKEDA", "BANANA18", "Source:", "https://www.indupo472cooouts.ucsf.edu/docs/gnjf0226" ]
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null
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gnjf0226_1.png
1,711
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{ "answers": [ { "answer_end": [ 5 ], "answer_start": [ 0 ], "text": [ "DEPARTMENT OF HEALTH & HUMAN SERVICES" ] }, { "answer_end": [ 71, 71 ], "answer_start": [ 69, 69 ], "text": [ "new drug application", "New drug application." ] }, { "answer_end": [ 53, 34 ], "answer_start": [ 52, 30 ], "text": [ "Ms. Pritza", "Mary Jo Pritza, MPH, PharmD" ] }, { "answer_end": [ 20 ], "answer_start": [ 18 ], "text": [ "DISCIPLINE REVIEW LETTER" ] }, { "answer_end": [ 50, 50 ], "answer_start": [ 47, 47 ], "text": [ "Feb 19 2007", "FEB 19 2007" ] } ], "question": [ "What is the name of the company mentioned in the letterhead?", "What is the fullform of NDA?", "What is the name of the addressee?", "What kind of a letter is this ?", "When did Regulatory affairs department receive this letter?" ], "question_id": [ 1040, 1042, 1044, 1047, 1124 ] }
[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "NDA", "21-073/S-026", "DISCIPLINE", "REVIEW", "LETTER", "Takeda", "Global", "Research", "&", "Development", "Center,", "Inc.", "RECEIVED", "Attention:", "Mary", "Jo", "Pritza,", "MPH,", "PharmD", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Manager,", "Regulatory", "Affairs", "One", "Takeda", "Parkway", "Deerfield,", "IL", "60015", "FEB", "1", "9", "2007", "Dear", "Ms.", "Pritza:", "TAKEDA", "GLOBAL", "RESEARCH", "&", "DEVELOPMENT", "CENTER,", "ING", "Please", "refer", "to", "your", "January", "24,", "2006,", "supplemental", "new", "drug", "application", "(NDA)", "submitted", "under", "section", "505(b)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos@", "(pioglitazone", "HCI)", "tablets,", "15", "mg,", "30", "mg,", "and", "45", "mg.", "We", "also", "refer", "to", "your", "submissions", "dated", "June", "1,", "August", "22", "and", "31,", "October", "10,", "November", "14,", "and", "December", "15,", "2006,", "and", "to", "our", "proposed", "labeling", "revisions", "sent", "to", "you", "(via", "e-mail)", "on", "February", "7,", "2007.", "Our", "review", "of", "the", "clinical", "section", "of", "your", "response", "to", "our", "labeling", "revisions", "is", "complete,", "and", "our", "summary", "of", "the", "rationale", "for", "our", "changes", "to", "your", "proposed", "label", "appear", "below.", "1.", "Movement", "of", "proposed", "information", "regarding", "outcome", "of", "the", "PROactive", "trial", "from", "the", "Clinical", "Studies", "section", "to", "the", "ADVERSE", "REACTIONS", "section,", "and", "inclusion", "of", "information", "only", "from", "the", "primary", "endpoint:", "This", "was", "a", "failed", "trial;", "statistical", "significance", "for", "the", "primary", "endpoint", "was", "not", "met,", "and", "the", "statistical", "evaluation", "does", "not", "support", "consideration", "of", "secondary", "endpoints", "in", "the", "event", "of", "failure", "to", "demonstrate", "significance", "for", "the", "primary", "endpoint.", "Even", "if", "you", "could", "demonstrate", "that", "it", "is", "statistically", "legitimate", "to", "consider", "secondary", "endpoints,", "the", "proposed", "\"main\"", "secondary", "endpoint", "was", "not", "placed", "in", "the", "statistical", "analysis", "plan", "until", "well", "after", "the", "trial", "had", "ended.", "Although", "technically", "it", "is", "possible", "to", "add", "new", "endpoints", "prior", "to", "breaking", "the", "blind,", "the", "long", "period", "of", "time", "(months)", "between", "study", "cessation", "and", "insertion", "of", "the", "new", "endpoint", "into", "the", "plan,", "the", "short", "period", "of", "time", "(days)", "between", "this", "addition", "and", "breaking", "of", "the", "blind,", "and", "the", "proposal", "to", "use", "this", "late-", "coming", "endpoint", "in", "the", "setting", "of", "a", "failed", "primary", "endpoint,", "give", "this", "endpoint", "the", "appearance", "of", "a", "post", "hoc", "analysis", "rather", "than", "a", "prospectively", "defined", "endpoint.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-PRITZM-00247931", "Produced", "in", "MDL", "on", "9/25/12", "Source:", "https://www.indusp0334..0000is.ucsf.edu/docs/kmjf0226" ]
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null
1
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kmjf0226_1.png
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2,236
{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "THE UPJOHN COMPANY" ] }, { "answer_end": [ 28 ], "answer_start": [ 26 ], "text": [ "September 21, 1993" ] }, { "answer_end": [ 31, 52, 31, 30 ], "answer_start": [ 29, 51, 29, 30 ], "text": [ "Tai Matsuzawa, Ph.D.", "Doctor Matsuzawa", "Tai Matsuzawa, Ph.D", "Matsuzawa" ] }, { "answer_end": [ 38 ], "answer_start": [ 38 ], "text": [ "Takeda" ] } ], "question": [ "What is the name of the company?", "What is the date mentioned?", "To whom is this letter addressed?", "As a consequence of the decision Upjohn must decline participation with which company?" ], "question_id": [ 1049, 1051, 1052, 1053 ] }
[ "EXHIBIT", "Ant", "THE", "UPJOHN", "COMPANY", "KALAMAZOO.", "MICHIGAN", "49001", "0199.", "U.5.4.", "TELEPHONE:", "(616)", "323", "4000", "J.", "R.", "MITCHELL,", "MD.,", "P.", "D.", "Vice", "Chairman", "of", "the", "doand", "PAR.", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid.", "1-1,", "Doshomachi", "4-Chome", "Chuo", "Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision", "making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message,", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards.", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indupoo02", "oooo-nts.ucsf.edu/docs/lljf0226" ]
null
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lljf0226_1.png
1,700
2,236
{ "answers": [ { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "Takeda" ] }, { "answer_end": [ 3 ], "answer_start": [ 1 ], "text": [ "19th January 2012" ] }, { "answer_end": [ 6 ], "answer_start": [ 5 ], "text": [ "Healthcare Professional" ] } ], "question": [ "What is the word written in bold on the top of the document?", "What is the date mentioned?", "To whom was this letter written?" ], "question_id": [ 1097, 1098, 1105 ] }
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[ 21, 961, 131, 972 ], [ 141, 961, 189, 973 ], [ 191, 961, 205, 973 ], [ 207, 961, 271, 973 ], [ 274, 961, 313, 973 ], [ 714, 959, 902, 972 ], [ 225, 983, 294, 997 ], [ 297, 981, 774, 997 ] ]
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{ "answers": [ { "answer_end": [ 18 ], "answer_start": [ 17 ], "text": [ "200 days" ] }, { "answer_end": [ 62, 62 ], "answer_start": [ 62, 61 ], "text": [ "1996", "since 1996" ] }, { "answer_end": [ 166 ], "answer_start": [ 164 ], "text": [ "Janet L. Haskins" ] }, { "answer_end": [ 70 ], "answer_start": [ 69 ], "text": [ "tobacco use" ] } ], "question": [ "A 79-year-old female was enrolled in the study for how many days?", "The patient had a history of bladder cancer since when?", "Who is the writer of the document?", "The woman had a positive history of what?" ], "question_id": [ 1055, 1056, 1058, 1059 ] }
[ "aked", "TAKEDA", "PHARMACEUTICALS", "NORTH", "AMERICA", "INC.", "Case", "Number", "Two:", "A", "79-year-old", "female,", "enrolled", "in", "the", "study", "for", "200", "days,", "was", "hospitalized", "for", "a", "bladder", "biopsy", "for", "possible", "recurrence", "of", "her", "bladder", "cancer.", "Cystoscopy", "revealed", "cancer", "in", "situ", "versus", "a", "recurrence", "of", "transitional", "cell", "bladder", "cancer.", "This", "patient", "has", "been", "discontinued", "from", "the", "trial.", "She", "has", "had", "a", "history", "of", "bladder", "cancer", "since", "1996", "and", "has", "a", "positive", "history", "of", "tobacco", "use.", "Drug", "Treatment:", "Pioglitazone", "HC!", "As", "noted", "in", "the", "November", "6th,", "conference", "call,", "TPNA", "will", "continue", "to", "investigate", "all", "cases", "of", "bladder", "cancer", "and", "as", "directed", "by", "the", "Division.", "Patients", "diagnosed", "with", "bladder", "cancer", "during", "the", "course", "of", "the", "study", "will", "be", "withdrawn", "from", "the", "trial", "and", "the", "study", "medication", "blind", "for", "those", "patients", "will", "be", "broken", "and", "reported", "to", "you.", "Also", "included", "in", "this", "submission", "are", "TPNA's", "minutes", "from", "the", "November", "1\"", "and", "6\"", "conference", "calls", "with", "the", "Division,", "If", "you", "have", "any", "questions", "regarding", "this", "submission,", "please", "feel", "free", "to", "contact", "me.", "\"Janet", "L.", "Haskins", "Manager,", "Regulatory", "Affairs", "Takeda", "Pharmaceuticals", "North", "America.", "Inc.", "847-383-3243", "(Telephone)", "847-383-3427", "(Fax)", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01273548", "Produced", "in", "MDL", "on", "09/11/2012", "Source:", "https://www.induptus/qcoooo2ts.ucsf.edu/docs/gyjf0226" ]
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2
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null
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{ "answers": [ { "answer_end": [ 38 ], "answer_start": [ 35 ], "text": [ "K. Kitazawa, Ph. D." ] }, { "answer_end": [ 32, 32 ], "answer_start": [ 30, 30 ], "text": [ "TAKEDA CHEMICAL INDUSTRIES, LTD.", "TAKEDA CHEMICAL INDUSTRIES , LTD ." ] }, { "answer_end": [ 5, 7 ], "answer_start": [ 5, 4 ], "text": [ "2", "Page 2 of 2" ] }, { "answer_end": [ 3, 3 ], "answer_start": [ 2, 2 ], "text": [ "October 25", "october 25" ] } ], "question": [ "Who is the general manager of International development Dept. of Takeda Chemical Industires, Ltd.?", "what is the name of the industry ?", "How many pages are there in total?", "what is the month and date mentioned in this letter, at the top ?" ], "question_id": [ 1057, 1061, 1063, 1065 ] }
[ "Dr.", "Ruppel", "October", "25", "Page", "2", "of", "2", "We", "are", "sorry", "for", "having", "had", "a", "delay", "in", "responding", "to", "your", "request", "because", "of", "my", "absence", "on", "business", "abroad.", "Sincerely", "yours,", "TAKEDA", "CHEMICAL", "INDUSTRIES", ",", "LTD.", "K.", "Kitazawa,", "Ph.", "D.", "General", "Manager", "International", "Development", "Dept.", "Pharmaceutical", "Development", "Div.", ".", ".", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065653", "Source:", "https://www.indupood3-oooo2ts.ucsf.edu/docs/mljf0226" ]
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2
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{ "answers": [ { "answer_end": [ 52, 52 ], "answer_start": [ 49, 49 ], "text": [ "WAC and AWP generally;", "WAC AND AWP generally;" ] }, { "answer_end": [ 26, 27 ], "answer_start": [ 26, 26 ], "text": [ "TPNA", "TPNA products" ] }, { "answer_end": [ 386, 388 ], "answer_start": [ 386, 386 ], "text": [ "11/30/2012", "11/30/2012 4:28:00 AM" ] }, { "answer_end": [ 56 ], "answer_start": [ 54 ], "text": [ "Medicare and Medicaid" ] } ], "question": [ "What is the fifth point?", "Education grants regarding which products?", "What is the date this document was last printed?", "Which reimbursement for TPNA pharmaceutical products is generally given?" ], "question_id": [ 1107, 1108, 1109, 1111 ] }
[ "3.", "Reports", "to", "any", "third", "party,", "including,", "but", "not", "limited", "to,", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "price", "reporting", "service,", "regarding", "prices", "for", "TPNA", "products;", "4.", "Communications", "with", "RedBook,", "First", "Data", "Bank,", "Blue", "Book,", "Medi-Span,", "or", "other", "pricing", "reporting", "services,", "regarding", "prices", "for", "TPNA", "products;", "5.", "WAC", "and", "AWP", "generally;", "6.", "Medicare", "and", "Medicaid", "reimbursement", "for", "TPNA", "pharmaceutical", "products", "generally;", "7.", "Calculation", "and", "reporting", "of", "Average", "Manufacturer", "Price", "and", "Best", "Price", "for", "TPNA", "products,", "as", "may", "be", "required", "by", "federal", "and", "state", "laws", "and", "regulations;", "8.", "Communications", "with", "any", "state", "or", "federal", "governmental", "agency", "regarding", "TPNA's", "participation", "in", "the", "Medicaid", "program;", "9.", "Invoices,", "internal", "sales", "projections,", "and", "profit", "statements", "that", "indicate", "the", "price", "TPNA", "paid", "for", "its", "products", "and", "the", "profits", "IPNA", "made", "based", "upon", "sales", "of", "these", "products;", "10.", "Meetings", "at", "which", "sales,", "marketing,", "and", "pricing", "decisions", "were", "discussed;", "11.", "Communications", "with", "providers,", "if", "any,", "relating", "to", "the", "use", "of", "the", "terms", "\"spread\"", "or", "\"profit\"", "in", "the", "context", "of", "the", "sale", "or", "marketing", "of", "TPNA", "products;", "12.", "Marketing", "materials", "(including", "proposed", "materials),", "if", "any,", "relating", "to", "the", "cost", "and", "\"spread\"", "for", "TPNA", "products;", "13.", "Provision", "of", "free", "samples", "or", "nominally", "priced", "TPNA", "products", "to", "any", "providers;", "and", "14.", "Educational", "grants", "regarding", "TPNA", "products;", "These", "requirements", "are", "related", "to", "all", "TPNA", "marketed", "products.", "Each", "Takeda", "Employee", "or", "Contractor", "shall", "create", "an", "Outlook", "Folder", "entitled", "\"AWP\"", "beneath", "the", "\"Legal", "Hold\"", "folder", "provided", "as", "part", "of", "the", "implementation", "of", "CORP-B-019", "\"E-mail", "Management", "and", "Retention.\"", "Contact", "the", "Help", "Desk", "if", "your", "Outlook", "file", "folder", "structure", "does", "not", "contain", "a", "\"Legal", "Hold\"", "folder.", "This", "means", "that", "all", "documents,", "materials,", "and", "computer", "files", "(including", "e-mails,", "word", "processing", "documents,", "slides,", "etc.)", "falling", "into", "this", "category", "must", "continue", "to", "be", "maintained", "until", "you", "are", "informed", "otherwise,", "regardless", "of", "the", "specified", "record", "retention", "period", "that", "would", "apply", "to", "such", "materials", "under", "Takeda's", "current", "Records", "Retention", "Schedules", "and", "program.", "You", "are", "reminded", "that", "you", "must", "follow", "the", "requirements", "of", "BOP,", "CORP-B-019", "\"E-mail", "Management", "and", "Retention\"", "for", "the", "retention", "of", "electronic", "materials,", "and", "the", "\"Best", "Practices", "For", "The", "Physical", "And", "Electronic", "Storage", "Of", "Materials", "That", "Must", "Be", "Retained", "For", "Legal", "Reasons....\"", "IN", "ALL", "CASES,", "THE", "FOLLOWING", "INSTRUCTIONS", "APPLY", "TO", "DOCUMENTS,", "MATERIALS,", "INFORMATION,", "AND", "THINGS,", "IN", "HARD", "COPY", "OR", "ELECTRONIC", "FORMAT,", "THAT", "ARE", "REQUIRED", "TO", "BE", "RETAINED", "PURSUANT", "TO", "THIS", "LEGAL", "HOLD.", "Last", "printed", "11/30/2012", "4:28:00", "AM", "20122830-042845", "doc", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00000665", "Source:", "https://www.indup5316-@0003ts.ucsf.edu/docs/frjf0226" ]
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frjf0226_3.png
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{ "answers": [ { "answer_end": [ 79 ], "answer_start": [ 77 ], "text": [ "Stacey Dixon Calahan" ] } ], "question": [ "By whom is this document written?" ], "question_id": [ 1066 ] }
[ "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "Address", ":", "One", "Takeda", "Parkway,", "Deerfield,", "IL", "60015,", "U.S.A", "Tel", ":", "+1-224-554-5586", "E-mail:", "stacey.calahan@takeda.com", "(Copy)", "Kazuyuki", "Kisaka", "Senior", "Director", "IP", "Licensing", "&", "R&D", "Contracts", "Takeda", "Pharmaceutical", "Company", "Limited", "Address:", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku,", "Osaka", "540-8645,", "Japan", "Tel:", "06-6204-2145", "E-mail:", "kazuyuki.kisaka@takeda.com", "In", "addition,", "we", "would", "appreciate", "your", "notifying", "me", "of", "any", "subpoenas", "or", "requests", "for", "information", "you", "may", "receive", "for", "Takeda", "or", "Actos-related", "information.", "Thank", "you", "in", "advance", "for", "your", "cooperation.", "Very", "truly", "yours,", "Stacey", "Dixon", "Calahan", "Assistant", "General", "Counsel,", "Litigation", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.", "cc:", "Stacie", "Switzer", "(Legal", "Department,", "Takeda", "Pharmaceuticals", "U.S.A.,", "Inc.)", "cc:", "Kazuyuki", "Kisaka", "(Legal", "Department,", "Takeda", "Pharmaceutical", "Company", "Limited)", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RIM30b6-00001063", "Source:", "https://www.indup5374", "00094ts.ucsf.edu/docs/ksjf0226" ]
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4
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{ "answers": [ { "answer_end": [ 449 ], "answer_start": [ 446 ], "text": [ "Vice President, Clinical Research" ] }, { "answer_end": [ 453, 458, 452 ], "answer_start": [ 450, 450, 450 ], "text": [ "Richard A. Rudick, M.D.", "Richard A. Rudick, M.D. Chairman, Division of Clinical Research", "Richard A. Rudick" ] }, { "answer_end": [ 142 ], "answer_start": [ 140 ], "text": [ "Federal Acquisitions Regulation" ] }, { "answer_end": [ 463 ], "answer_start": [ 459 ], "text": [ "5/8/07" ] } ], "question": [ "What is the designation of Alfonso T. Perez, M.D.?", "By whom was this agreement Agreed and Accepted?", "What is the full form of FAR?", "What is the date of the signature of the chairman of the Division of clinical research?" ], "question_id": [ 1113, 1114, 1115, 1122 ] }
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{ "answers": [ { "answer_end": [ 5, 5 ], "answer_start": [ 0, 0 ], "text": [ "DEPARTMENT OF HEALTH AND HUMAN SERVICES", "department of health and human services." ] }, { "answer_end": [ 77 ], "answer_start": [ 77 ], "text": [ "11/18/2002" ] }, { "answer_end": [ 99 ], "answer_start": [ 99 ], "text": [ "847-383-3739" ] }, { "answer_end": [ 240 ], "answer_start": [ 239 ], "text": [ "5 0 1" ] }, { "answer_end": [ 18, 18 ], "answer_start": [ 16, 16 ], "text": [ "November 30, 2002", "november 30, 2002" ] }, { "answer_end": [ 76, 75 ], "answer_start": [ 72, 72 ], "text": [ "Takeda Pharmaceuticals North America, Inc.", "Takeda Pharmaceuticals North america , Inc." ] } ], "question": [ "to which department it belongs to ?", "what is the date of submission?", "what is the telephone number (include area code)?", "What is the serial number mentioned in the form?", "what is the expiration date ?", "what is the name of the sponsor ?" ], "question_id": [ 1070, 1073, 1074, 1076, 1077, 1078 ] }
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gyjf0226_3.png
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{ "answers": [ { "answer_end": [ 53 ], "answer_start": [ 51 ], "text": [ "January 21, 1999" ] }, { "answer_end": [ 57, 75 ], "answer_start": [ 55, 74 ], "text": [ "Mr. Larry Ellingson", "Mr. Ellingson" ] }, { "answer_end": [ 60 ], "answer_start": [ 59 ], "text": [ "Kunio Iwatani" ] }, { "answer_end": [ 231 ], "answer_start": [ 230 ], "text": [ "DALY 19" ] } ], "question": [ "What is the date mentioned?", "To whom is this document addressed?", "By whom is this document written?", "What is written in big bold letters at the bottom?" ], "question_id": [ 1068, 1069, 1071, 1083 ] }
[ "FROM", "HERETAN", "DEMAS", "FAX05-6204-2943", "19994", "18218", "(*)", "21", "31/21", ":", "28/x56:480:", "941295", "F", "1", "Takeda", "Chemical", "Industries,", "Ltd.", "Takeda", "Product", "Planning", "&", "Management", "Dept.,", "International", "Division", "1-1", "Doshomachi", "4-chome,", "Chuo-Ku,", "Osaka", "541,", "JAPAN", "Tel:", "+81", "6", "(204)", "2852", "Fax:", "+81", "6", "(204)", "2943", "TELEFAX", "MESSAGE", "To:", "E.", "Lilly", "&", "Company", "Date:", "January", "21,", "1999", "Att:", "Mr.", "Larry", "Ellingson", "From:", "Kunio", "Iwatani", "Executive", "Director", "Actos", "Product", "Team", "CC:", "Mr.", "Hamanaka,", "TPA", "Subject:", "Upjohn", "Matter", "Dear", "Mr.", "Ellingson,", "Enclosed", "please", "find", "a", "copy", "of", "Upjohn's", "letter", "to", "US", "FDA", "dated", "January", "7,", "1994.", "In", "the", "letter", "Upjohn", "said", "that", "in", "preliminary", "clinical", "evaluation", "in", "the", "United", "States,", "pioglitazone", "did", "not", "satisfy", "Upjohn's", "internal", "requirement", "for", "reduction", "blood", "glucose;", "therefore,", "the", "considerable", "programs", "required", "for", "development", "of", "pioglitazone", "are", "not", "in", "line", "with", "Upjohn's", "business", "needs.", "-..", "They", "did", "not", "mention", "about", "safety", "of", "pioglitazone.", "After", "Upjohn's", "decision,", "Takeda", "approached", "FDA", "and", "consulted", "whether", "Takeda", "might", "go", "further", "the", "clinical", "development", "works", "on", "pioglitazone.", "Since", "the", "FDA's", "response", "was", "positive", "to", "go", "ahead,", "Takeda", "took", "over", "Upjohn's", "works", "and", "finally", "filed", "NDA", "on", "January", "15,", "1999.", "This", "is", "the", "story", "of", "the", "fact.", "Although", "there", "may", "be", "rumors", "about", "the", "reasons", "of", "Upjohn's", "abandonment", "of", "pioglitazone", "development,", "specially", "from", "the", "viewpoints", "of", "safety", "issues,", "it", "might", "be", "advisable", "for", "us", "to", "keep", "saying", "that", "Upjohn's", "decision", "is", "based", "on", "JAN", "21", "'99", "07:43", "DALY", "19", "06", "6204", "2943", "PAGE", ".", "01", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-CRCARCH-00003000", "Source:", "https://www.indupbodsfoodonts.ucsf.edu/docs/nljf0226" ]
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1
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{ "answers": [ { "answer_end": [ 188 ], "answer_start": [ 186 ], "text": [ "any macroscopic haematuria" ] }, { "answer_end": [ 12, 12 ], "answer_start": [ 11, 11 ], "text": [ "Heart failure", "heart failure" ] }, { "answer_end": [ 249 ], "answer_start": [ 249 ], "text": [ "Actos/Competact" ] }, { "answer_end": [ 51 ], "answer_start": [ 50 ], "text": [ "19 cases" ] } ], "question": [ "what has to be investigated before starting pioglitazone therapy?", "what has been experienced commonly in patients taking actos in combination with insulin?", "Which medicine is used to treat type 2 diabetes mellitus?", "How many cases of bladder cancer from 12506 patients were reported?" ], "question_id": [ 1079, 1080, 1084, 1087 ] }
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{ "answers": [ { "answer_end": [ 204 ], "answer_start": [ 201 ], "text": [ "Mary H. Parks, M.D." ] }, { "answer_end": [ 205 ], "answer_start": [ 205 ], "text": [ "Director" ] }, { "answer_end": [ 193 ], "answer_start": [ 191 ], "text": [ "Regulatory Project Manager" ] }, { "answer_end": [ 180 ], "answer_start": [ 180 ], "text": [ "301-796-1306" ] } ], "question": [ "Who has signed this document?", "What is the designation of Mary H.Parks, M.D.?", "What is the designation of Ms. Jena Weber?", "What is the contact no of Ms. Jena Weber?" ], "question_id": [ 50949, 50951, 50952, 50955 ] }
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{ "answers": [ { "answer_end": [ 30, 30 ], "answer_start": [ 28, 27 ], "text": [ "Cleveland Clinic Foundation", "The Cleveland Clinic Foundation" ] }, { "answer_end": [ 34, 34 ], "answer_start": [ 31, 31 ], "text": [ "Department of Cardiovascular Medicine", "Department of Cardiovascular Medicine." ] }, { "answer_end": [ 40 ], "answer_start": [ 40 ], "text": [ "931535" ] }, { "answer_end": [ 45 ], "answer_start": [ 45 ], "text": [ "34-0714585" ] } ], "question": [ "Which foundation is mentioned in this document?", "Under which department , The Cleveland Clinic Foundation operates?", "What is the PO Box number?", "What is the Tax ID mentioned in this document?" ], "question_id": [ 1081, 1082, 1088, 1094 ] }
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zfkf0226_2.png
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{ "answers": [ { "answer_end": [ 125 ], "answer_start": [ 125 ], "text": [ "33,729" ] }, { "answer_end": [ 242 ], "answer_start": [ 241 ], "text": [ "4 9 7" ] }, { "answer_end": [ 78 ], "answer_start": [ 77 ], "text": [ "11/1/02" ] }, { "answer_end": [ 124, 124 ], "answer_start": [ 122, 122 ], "text": [ "ACTOS (pioglitazone HCI)", "ACTOS (Pioglitazone HCI)" ] }, { "answer_end": [ 10, 10 ], "answer_start": [ 10, 10 ], "text": [ "0910-0014", "0910-0014." ] } ], "question": [ "what is the IND mumber (if previously assigned ) ?", "What is the serial number mentioned in the form?", "what is the date of submission ?", "what is the Name(s) of drug (include all available names: Trade , Generic, Chemical, Code)?", "what is the form approved : OMB No" ], "question_id": [ 1090, 1091, 1092, 1093, 1096 ] }
[ "DEPARTMENT", "OF", "HEALTH", "AND", "HUMAN", "SERVICES", "Form", "Approved:", "OMB", "No.", "0910-0014", "PUBLIC", "HEALTH", "SERVICE", "Expiration", "Date:", "November", "30,", "2002", "FOOD", "AND", "DRUG", "ADMINISTRATION", "See", "OMB", "Statement", "on", "Reverse,", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "NOTE:", "No", "drug", "may", "be", "shipped", "or", "clinical", "(TITLE", "21,", "CODE", "OF", "FEDERAL", "REGULATIONS", "(CFR)", "PART", "312)", "Investigation", "begun", "until", "an", "IND", "for", "that", "investigation", "is", "in", "effect", "(21", "CFR", "312.40).", "1.", "NAME", "OF", "SPONSER", "2.", "DATE", "OF", "SUBMISSION", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "1", "1/1/02", "3.", "ADDRESS", "(Number,", "Street,", "City,", "State", "and", "Zip", "Code)", "4.", "TELEPHONE", "NUMBER", "(Include", "Area", "Code)", "475", "Half", "Day", "Road,", "Suite", "500", "847-383-324.", "oinshire,", "IL", "60069", "5.", "NAME(S)", "OF", "DRUG", "(Include", "all", "available", "names:", "Trade,", "Generic,", "Chemical,", "Code)", "6.", "IND", "NUMBER", "(if", "previously", "assigned)", "ACTOS@", "(pioglitazone", "HCI", "33,72", "7.", "INDICATION(S)", "(Covered", "by", "the", "N/A", "8.", "PHASE(S)", "OF", "CLINICAL", "INVESTIGATION", "TO", "BE", "CONDUCTED:", "O", "PHASE", "1", "0", "PHASE", "2", "PHASE", "3", ")", "OTHER", "N/A", "(Specify)", "9.", "LIST", "NUMBERS", "OF", "ALL", "INVESTIGATIONAL'", "NEW", "DRUG", "APPLICATIONS", "(21", "CFR", "Part", "312),", "NEW", "DRUG", "OR", "ANTIBIOTIC", "APPLICATIONS", "(21", "CFR", "Part", "314).", "DRUG", "MASTER", "FILES", "(21", "CFR", "Part", "314.420),", "AND", "PRODUCT", "LICENSE", "APPLICATIONS", "(21", "CFR", "Part", "601)", "REFERRED", "TO", "IN", "THIS", "APPLICATION.", "N/A", "10.", "IND", "submission", "should", "be", "consecutively", "numbered.", "The", "Initial", "IND", "should", "be", "numbered", "\"Serial", "number:", "000.\"", "The", "next", "submission", "(e.g.,", "amendment,", "report,", "or", "correspondence)", "SERIAL", "NUMBER", "should", "be", "numbered", "\"Serial", "Number:", "001.\"", "Subsequent", "submissions", "should", "be", "numbered", "consecutively", "in", "the", "order", "in", "which", "they", "are", "submitted.", "4", "7", "11.", "THIS", "SUBMISSION", "CONTAINS", "THE", "FOLLOWING:", "(Check", "all", "that", "apply)", "C)", "INITIAL", "INVESTIGATIONAL", "NEW", "DRUG", "APPLICATION", "(IND)", "ORESPONSE", "TO", "CLINICAL", "HOLD", "PROTOCOL", "AMENDMENT(S):", "INFORMATION", "AMENDMENT(S):", "IND", "SAFETY", "REPORT(S)", "NEW", "PROTOCOL", "\"CHEMISTRY/MICROBIOLOGY", "[]", "PHARMACOLOGY/TOXICOLOGY", "INITIAL", "WRITT", "CHANGE", "IN", "PROTOCOL", "FOLLOW-UP", "TO", "A", "WRITTEN", "REPORT", "O", "NEW", "INVESTIGATOR", "CLINICAL", "X", "RESPONSE", "TO", "FDA", "REQUEST", "FOR", "INFORMATION", "OANNUAL", "REPORT", "GENERAL", "CORRESPONDENCE", "\"", "REQUEST", "FOR", "REINSTATEMENT", "OF", "IND", "THAT", "IS", "WITHDRAWN,", "INACTIVATED,", "TERMINATED", "OR", "DISCONTINUED", "OTHER", "(Specify)", "CHECK", "ONLY", "IF", "APPLICABLE", "JUSTIFICATION", "STATEMENT", "MUST", "BE", "SUBMITTED", "WITH", "APPLICATION", "FOR", "ANY", "CHECKED", "BELOW.", "REFER", "TO", "THE", "CITED", "CFR", "SECTION", "FOR", "FURTHER", "INFORMATION.", "TREATMENT", "IND", "21", "CFR", "312.35(b)", "[TREATMENT", "PROTOCOL", "21", "CFR", "312.35(a)", "[", "CHARGE", "REQUEST/NOTIFICATION", "21", "CFR312.7(d)", "FOR", "FDA", "USE", "ONLY", "CDR/DBIND/DGD", "RECEIPT", "STAMP", "DDR", "RECEIPT", "STAMP", "DIVISION", "ASSIGNMENT:", "IND", "NUMBER", "ASSIGNED", "FORM", "FDA", "1571", "(9/02)", "PREVIOUS", "EDITION", "IS", "OBSOLETE.", "PAGE", "1", "OF", "2", "PSC", "Media", "Arts", "Branch", "(301)", "643-1090", "ER", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00015505", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indup2292-00003s.ucsf.edu/docs/tyjf0226" ]
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null
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tyjf0226_3.png
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{ "answers": [ { "answer_end": [ 26, 26 ], "answer_start": [ 22, 22 ], "text": [ "Takeda Pharmaceuticals North America, Inc.", "TAkeda pharmaceuticals North America ,INc." ] }, { "answer_end": [ 30, 30, 54 ], "answer_start": [ 28, 28, 53 ], "text": [ "Janet L. Haskins", "janet L. haskins", "Ms. Haskins" ] }, { "answer_end": [ 34 ], "answer_start": [ 31 ], "text": [ "JUN 16 2003" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "Ms. Jens Weber" ] } ], "question": [ "what is the name of pharmaceuticals ?", "to whom this letter is written ?", "When did Regulatory affairs department receive this letter?", "To whom a copy of cover letter has to be sent ?" ], "question_id": [ 1099, 1101, 1102, 1110 ] }
[ "DEPARTMENT", "OF", "HEALTH", "&", "HUMAN", "SERVICES", "Public", "Health", "Service", "Food", "and", "Drug", "Administration", "Rockville,", "MD", "20857", "IND", "33,729", "RECEIVED", "REGULATORY", "AFFAIRS", "DEPARTMENT", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Attention:", "Janet", "L.", "Haskin", "JUN", "1", "6", "2003", "Manager,", "Regulatory", "Affairs", "475", "Half", "Day", "Road,", "Suite", "500", "Takeda", "Pharmaceuticals", "North", "America,", "Ins", "Lincolnshire,", "IL", "60069", "Dear", "Ms.", "Haskins:", "Please", "refer", "to", "your", "Investigational", "New", "Drug", "Application", "(IND)", "submitted", "January", "15,", "1999,", "under", "section", "505(i)", "of", "the", "Federal", "Food,", "Drug,", "and", "Cosmetic", "Act", "for", "Actos", "(pioglitazone", "HCI)", "Tablets,", "15", "mg,", "30", "mg", "and", "45", "mg", "We", "also", "refer", "to", "your", "amendment", "dated", "May", "8,", "2003", "(serial", "#", "525),", "received", "on", "May", "9,", "2003,", "that", "provided", "a", "response", "to", "our", "November", "13,", "2002,", "letter", "which", "cited", "the", "reasons", "this", "protocol", "was", "placed", "on", "clinical", "hold", "and", "the", "information", "needed", "to", "resolve", "the", "clinical", "hold", "issues.", "We", "have", "completed", "the", "review", "of", "your", "submission", "and", "have", "concluded", "that", "removal", "of", "the", "clinical", "hold", "is", "not", "warranted.", "We", "acknowledge", "your", "agreement", "to", "monitor", "for", "bladder", "tumors", "in", "your", "clinical", "studies,", "and", "to", "amend", "the", "label", "and", "consent", "documents.", "However,", "until", "further", "information", "on", "bladder", "effects", "from", "ongoing", "studies", "is", "available,", "we", "do", "not", "believe", "studies", "in", "pediatric", "patients", "are", "warranted.", "Until", "you", "have", "submitted", "the", "required", "information", "and", "we", "notify", "you", "that", "you", "may", "initiate", "trials,", "this", "IND", "remains", "on", "clinical", "hold", "and", "you", "may", "not", "legally", "conduct", "clinical", "studies", "under", "it.", "Please", "identify", "your", "response", "to", "the", "clinical", "hold", "issues", "as", "a", "\"CLINICAL", "HOLD", "COMPLETE", "RESPONSE.\"", "To", "facilitate", "a", "response", "to", "your", "submission,", "submit", "this", "information", "in", "triplicate", "to", "the", "IND.", "In", "addition,", "send", "a", "copy", "of", "the", "cover", "letter", "to", "Ms.", "Jena", "Weber.", "Following", "receipt", "of", "your", "complete", "response", "to", "these", "issues,", "we", "will", "notify", "you", "of", "our", "decision", "within", "30", "days.", "424", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577085", "in", "MDL", "on", "01/31/13", "Source:", "https://www.induptrygg-ooooits.ucsf.edu/docs/xyjf0226" ]
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1
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null
null
xyjf0226_1.png
1,702
2,238
{ "answers": [ { "answer_end": [ 132 ], "answer_start": [ 132 ], "text": [ "425" ] }, { "answer_end": [ 102 ], "answer_start": [ 102 ], "text": [ "301-827-6422" ] }, { "answer_end": [ 65 ], "answer_start": [ 62 ], "text": [ "Office of Drug Evaluation" ] }, { "answer_end": [ 1 ], "answer_start": [ 0 ], "text": [ "IND 33, 729" ] } ], "question": [ "What is the number written above TAK-INDNDA-01577086?", "What is the contact number of Ms. Jena Weber, Regulatory Project Manager?", "What is the full form of ODE?", "What is written above Page 2 on the top?" ], "question_id": [ 1116, 1117, 1118, 1119 ] }
[ "IND", "33,729", "Page", "2", "Correspondence", "to", "this", "IND", "can", "be", "sent", "to", "the", "following", "address:", "U.S.", "Postal", "Service/", "Courier/Overnight", "Mail:", "Food", "and", "Drug", "Administration", "Center", "for", "Drug", "Evaluation", "and", "Research", "Division", "of", "Metabolic", "and", "Endocrine", "Drug", "Products,", "HFD-$10", "Attention:", "Division", "Document", "Room,", "8B-45", "5600", "Fishers", "Lane", "Rockville,", "Maryland", "20857", "You", "may,", "at", "any", "time,", "appeal", "the", "clinical", "hold", "decision", "to", "the", "Director,", "Office", "of", "Drug", "Evaluation", "ODE", "II.", "However,", "note", "that", "our", "procedures", "specify", "that", "review", "by", "the", "Office", "Director", "is", "automatic", "for", "continuance", "of", "a", "clinical", "hold.", "If", "you", "have", "any", "questions,", "please", "call", "Ms.", "Jena", "Weber,", "Regulatory", "Project", "Manager,", "at", "301-827-6422.", "Sincerely,", "(See", "appended", "electronic", "signature", "page)", "David", "G.", "Orloff,", "M.D.", "Director", "Division", "of", "Metabolic", "and", "Endocrine", "Drug", "Products", "Office", "of", "Drug", "Evaluation", "II", "Center", "for", "Drug", "Evaluation", "and", "Research", "425", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-INDNDA-01577086", "Produced", "in", "MDL", "on", "01/31/13", "Source:", "https://www.indupt1739-00002ts.ucsf.edu/docs/xyjf0226" ]
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null
2
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null
null
xyjf0226_2.png
1,705
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{ "answers": [ { "answer_end": [ 8 ], "answer_start": [ 8 ], "text": [ "7200" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "9/23/93" ] }, { "answer_end": [ 15, 15 ], "answer_start": [ 14, 14 ], "text": [ "PJ Daniels", "pj Daniels" ] }, { "answer_end": [ 6, 6 ], "answer_start": [ 4, 4 ], "text": [ "Timothy J. Gumbleton", "timothy J Gumbleton" ] }, { "answer_end": [ 32, 32 ], "answer_start": [ 32, 32 ], "text": [ "DR. Mitchell", "Dr. Mitchell" ] } ], "question": [ "what is the unit mentioned in the letter ?", "what is the date mentioned", "Name of the first person in the To list?", "from whose desk this letter is written ?", "Whose letter's copy is attached?" ], "question_id": [ 1120, 1121, 1123, 1125, 1126 ] }
[ "FROM", "THE", "DESK", "OF:", "Timothy", "J.", "Gumbleton", "UNIT:", "7200", "BLOG", ":", "24-1", "EXT:", "5-7054", "PJ", "Daniels", "LSolanoff", "DATE:", "9/23/42", "PL", "Ruppel", "L", "Twelch", "Attached", "is", "a", "cozy", "of", "the", "letter", "from", "Dn,", "Mitchell", "to'", "DA.", "Matsozawa", "It", "was", "faxed", "today", ",", "Do.", "Mitchell", "added", "one", "sentence", "ox", "the", "bottom", "of", "Paragraph", "3.", "He", "said", "that", "me", "further", "contact", "with", "Takecia", "Should", "be", "made", "until", "we", "receive", "a", "reply", "from", "them.", "Please", "call", "if", "you", "have", "any", "questions", ".", "Upjohn", "DALY", "18", "CONFIDENTIAL", "-", "SUBJECT", "UPJ-0065602DEI", "Source:", "https://www.indupodscoo09nts.ucsf.edu/docs/zsjf0226" ]
null
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null
null
zsjf0226_1.png
1,728
2,257
{ "answers": [ { "answer_end": [ 14, 14 ], "answer_start": [ 12, 12 ], "text": [ "February 6, 1996", "february 6 , 1996" ] }, { "answer_end": [ 18, 18 ], "answer_start": [ 16, 16 ], "text": [ "Dr. K. KItazawa", "Dr . k. Kitazawa" ] }, { "answer_end": [ 25, 253 ], "answer_start": [ 24, 252 ], "text": [ "T. Suzuki", "Tsuyoshi Suzuki , M S ." ] }, { "answer_end": [ 32, 32 ], "answer_start": [ 29, 29 ], "text": [ "Drug Safety Research Laboratories", "drug safety research laboratories ." ] } ], "question": [ "what is the date mentioned ?", "to whom this letter is written ?", "this letter is written by whom ?", "Which laboratory is T. Suzuki associated with ?" ], "question_id": [ 1128, 1129, 1130, 1131 ] }
[ "..", "Encl.", "2", "Draft", "2", "/", "1", "1", "TAKEDA", "INTERNATIONAL", "COMMUNICATION", "Date", "February", "6,", "1996", "To", "Dr.", "K.", "Kitazawa", "General", "Manager", "International", "Development", "From", "T.", "Suzuki", "Senior", "Research", "Head", "Drug", "Safety", "Research", "Laboratories", "Subject", "A", "Prompt", "Report", "for", "Interim", "Results", "of", "AD-4833", "2Y", "Rat", "&", "Mouse", "Studies", "We", "are", "performing", "two-your", "carcinogenicity", "studies", "in", "rats", "and", "mice", "at", "MPI", "(formerly;", "[RDC)", "Research", "Labs.", "Pathological", "examinations", "of", "these", "studies", "have", "almost", "finished", "recently.", ":", "In", "the", "rat", "study,", "a", "treatment-related", "increase", "in", "incidence", "of", "transitional", "cell", "tumors", "in", "the", "winary", "bladder", "was", "seen.", "1)", "Rat", "study", "Sixty", "Sprague-Dawley", "Cri:CD\"", "BR", "rats/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "1,", "4,", "8,", "16", "and", "63mg/kg/day", "for", "males", "and", ",", "4,", "16", "and", "63mg/kg/day", "for", "females.", "The", "incidence", "of", "transitional", "cell", "benign", "tumor", "and/or", "transitional", "cell", "carcinoma", "in", "the", "urinary", "bladder", "was", "increased", "in", "males", "receiving", "4mg/ke/day", "or", "more.", "In", "females,", "transitional", "call", "benign", "tumor", "in", "the", "same", "organ", "was", "seen", "in", "each", "one", "animal", "receiving", "1,", "4", "and", "16mig/kg/day.", "There", "is", "no", "treatment-", "related", "increase", "in", "incidence", "of", "tumors", "in", "any", "other", "organs.", "2)", "Mouse", "study", "Sixty", "CHI:CD", "(ICR)", "BR", "VAF/Plus\"", "mice/sex/group", "were", "administered", "AD-4833", "(HCI)", "at", "doses", "of", "3,", "10.", "30", "and", "100me/ke/day.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs.", "There", "is", "no", "treatment-related", "increase", "in", "incidence", "of", "tumors", "in", "any", "organs", "in", "2-year", "mouse", "and", "one", "year", "dog", "and", "monkey", "study.", "Thus,", "it", "is", "supposed", "that", "increased", "tumors", "in", "urinary", "bladder", "might", "be", "species", "specific.", ".", "...", "Tsuyoshi", "Suzuki,", "M.", "S.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-COHENS-00006201", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.induBQ178-2090nits.ucsf.edu/docs/hmjf0226" ]
null
null
1
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null
null
hmjf0226_1.png
1,701
2,237
{ "answers": [ { "answer_end": [ 42, 42 ], "answer_start": [ 40, 40 ], "text": [ "August 8, 2002", "august 8 , 2002" ] }, { "answer_end": [ 20, 21 ], "answer_start": [ 18, 18 ], "text": [ "Takeda chemical industries, LTD .", "TAKEDA CHEMICAL INDUSTRIES, LTD." ] }, { "answer_end": [ 39, 74 ], "answer_start": [ 37, 73 ], "text": [ "Dr. Claire Thom", "Dr. Thom" ] }, { "answer_end": [ 63, 63 ], "answer_start": [ 61, 61 ], "text": [ "Mr. S. Hamanaka", "Mr . S . Hamanaka" ] }, { "answer_end": [ 125, 125 ], "answer_start": [ 124, 124 ], "text": [ "Katsuhisa Saito", "katsuhisa saito" ] }, { "answer_end": [ 49 ], "answer_start": [ 49 ], "text": [ "TPNA-TS-020808" ] } ], "question": [ "what is the date mentioned in the letter", "What is the name of the industry given here?", "to whom this letter is written ?", "what is the name mentioned in CC", "Who sent this letter?", "what is Ref: code mentioned ?" ], "question_id": [ 1132, 1133, 1134, 1135, 1136, 1137 ] }
[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:", "49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "001/006", "116", "TAKEDA", "CHEMICAL", "INDUSTRIES,", "LTD.", "Pharmaceutical", "Development", "Division", "1-1,", "Doshomachi", "4-chome,", "Chuo-ku", "OSAKA", "540-8645,", "Japan", "Phone", "+81-6-6204-2259", "/", "Facsimile", "+81-6-6204-2244", "Dr.", "Claire", "Thom", "August", "8,", "2002", "Takeda", "Pharmaceuticals", "North", "America,", "Inc.", "Ref:", "TPNA-TS-020808", "475", "Half", "Day", "Road,", "Suite", "500", "Lincolnshire,", "IL", "60069,", "USA", "CC", "Mr.", "S.", "Hamanaka", "Urgent", "Re:", "ACTOS", "Pages(", "Including", "Cover)", ":", "6", "Dear", "Dr.", "Thom,", "We", "faxed", "you", "three", "documents", "regarding", "Actos.", "1.", "Comments", "about", "a", "contact", "with", "NN", "2.", "Action", "plan", "for", "NN", "issue", "3.", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "If", "you", "have", "any", "questions,", "please", "do", "not", "hesitate", "to", "contact", "us.", "Best", "wishes,", "K.", "Saito", "Katsuhisa", "Saito", "Dept.", "Strategic", "Development", "Pharmaceutical", "Development", "Division", "Takeda", "Chemical", "Industries,", "LTD.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019744", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodomoooonts.ucsf.edu/docs/pljf0226" ]
null
null
1
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null
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pljf0226_1.png
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{ "answers": [ { "answer_end": [ 43 ], "answer_start": [ 42 ], "text": [ "TPNA, Chicago" ] }, { "answer_end": [ 40 ], "answer_start": [ 34 ], "text": [ "Monday, 12 and Tuesday, 13 August 2002" ] }, { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "06 6204 2244" ] }, { "answer_end": [ 150 ], "answer_start": [ 150 ], "text": [ "pioglitazone" ] } ], "question": [ "What is the venue mentioned in the document?", "What is the date mentioned in the document?", "what is the fax number mentioned in the letter at the top?", "Which drug's toxicity study results will be discussed ?" ], "question_id": [ 1138, 1139, 1140, 1230 ] }
[ "08/07/2002", "18:47", "06", "6204", "2244", ".", "2002'", "08/08", "21:50", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "2", "006/006", "6", "/", "6", "Discussion", "points", "to", "address", "the", "three", "key", "issues", "raised", "by", "the", "FDA", "Date:", "Monday,", "12", "and", "Tuesday,", "13", "August", "2002", "Venue:", "TPNA,", "Chicago", "ISSUES", "1.", "They", "requested", "us", "to", "propose", "a", "method", "by", "which", "to", "monitor", "bladder", "toxicity", "in", "patients", "in", "our", "long", "term", "phase", "4", "clinical", "trials", "(long", "term", "was", "defined", "as", "at", "least", "1", "year)", "2.", "They", "indicated", "an", "inclination", "to", "rescind", "the", "written", "request", "for", "pediatric", "exclusivity", "based", "on", "their", "concern", "about", "bladder", "tumors.", "3.", "They", "requested", "us", "to", "give", "some", "consideration", "to", "a", "label", "change", "that", "would", "reflect", "possible", "relatedness", "of", "tumor", "formation", "to", "mechanism", "(dual", "PPAR", "agonist)", "instead", "of", "the", "current", "language", "(\"The", "relationship", "of", "these", "findings", "in", "male", "rats", "to", "humans", "is", "unclear.\")", "DISCUSSION", "POINTS", "to", "briefly", "review", "the", "toxicity", "study", "results", "of", "pioglitazone,", "particularly", "carcinogenicity", "studies", "b.", "to", "summarise", "discussions", "with", "the", "CPMP", "to", "submit", "literature", "suggesting", "that", "pioglitazone", "suppresses", "the", "cell", "growth,", "particularly", "urinary", "bladder", "cell", "1.", "to", "perform", "an", "in-vitro", "study", "to", "evaluate", "the", "cell", "growth", "and", "cell", "growth", "inhibition", "with", "piogliatzone", "e.", "to", "investigate", "carbonic", "anhydrase", "inhibiting", "activity", "of", "NN622,", "pioglitazone", "and", "rosiglitazone", "f.", "to", "compare", "PPAR", "agonists", "in", "terms", "of", "alpha", "and", "gamma", "activities", "g.", "to", "differentiate", "between", "glitazones", "and", "glitazars", "h.", "to", "consult", "with", "non-clinical", "external", "experts", "for", "their", "expertise", "i.", "to", "find", "a", "rationale", "for", "not", "doing", "clinical", "monitoring", "j-", "a", "monotoring", "method", "k", ".", "a", "case", "control", "study", "1.", "a", "pharmacoepidemiology", "study", "m.", "to", "submit", "a", "report", "from", "a", "Japanese", "follow", "up", "study", "for", "pioglitazone", "n.", "to", "assess", "cases", "from", "database", "search", "for", "pioglitazone", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019749", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoboosts.ucsf.edu/docs/pljf0226" ]
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6
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pljf0226_6.png
1,700
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{ "answers": [ { "answer_end": [ 9 ], "answer_start": [ 6 ], "text": [ "10/27/93 09:36:07" ] }, { "answer_end": [ 35, 35 ], "answer_start": [ 34, 34 ], "text": [ "Pioglitazone statement", "pioglitazone statement" ] }, { "answer_end": [ 17, 17 ], "answer_start": [ 15, 11 ], "text": [ "PETER J. DANIELS", "PJ DANIEL--PW17PO PETER J. DANIELS" ] }, { "answer_end": [ 6, 123 ], "answer_start": [ 6, 122 ], "text": [ "10/26/93", "10/26/93 15:44" ] }, { "answer_end": [ 123 ], "answer_start": [ 123 ], "text": [ "15:44" ] }, { "answer_end": [ 132, 132 ], "answer_start": [ 131, 130 ], "text": [ "RUPPEL, PATRICIA", "PLRUPPEL--RCC1 RUPPEL, PATRICIA" ] } ], "question": [ "what is the date and time mentioned ?", "what is mentioned in the subject ?", "To whom this email was send?", "what is the date mentioned in the forwarding note ?", "what is the time mentioned in the forwarding note ?", "To whom this email was forwaded?" ], "question_id": [ 1141, 1142, 1143, 1144, 1145, 1146 ] }
[ "From:", "PLK", "RCC1", "Date", "and", "time", "10/27/93", "09", ":", "36:07", "To:", "PJDANIEL-", "-", "PW17", "PO", "PETER", "J.", "DANIELS", "CC:", "RJWELTER-", "-", "PW17", "PO", "RICHARD", "J.", "WELTER", "LTWELCH", "--RCC1", "LAWRENCE", "T", "WELCH", "From:", "plruppel", "subject:", "Pioglitazone", "statement", "Actually,", "this", "statement", "reflects", "pretty", "accurately", "the", "stand", "that", "Jim", "Moe", "and", "Larry", "Olanoff", "presented", "to", "Takeda", "in", "Osaka.", "There", "are", "preclinical", "issues", "and", "the", "amount", "of", "preclinical", "work", "that", "would", "be", "needed", "to", "address", "these", "issues", "and", "the", "modest", "clinical", "efficacy", "that", "has", "been", "seen", "do", "not", "justify", "development", "in", "accordance", "with", "Upjohn's", "business", "needs.", "Larry", "does", "not", "feel", "that", "there", "is", "a", "need", "for", "an", "\"Upjohn", "statement\".", "Please", "let", "me", "know", "if", "you", "want", "to", "discuss", "this", "further.", "Patty", "***", "Forwarding", "note", "from", "PJDANIEL--PW17PO", "10/26/93", "15:44", "*", "*", "*", "From:", "PJDANIEL", "To:", "PLRUPPEL--RCC1", "RUPPEL,", "PATRICIA", "CC", ":", "PJDANIEL", "RJWELTER", "LTWELCH", "-", "-RCC1", "WELCH,", "LAWRENCE", "Subject:", "Pioglitazone", "statement", "Patty,", "thanks", "for", "the", "Takeda", "letter.", "Some", "of", "my", "colleagues", "are", "concerned", "about", "the", "lack", "of", "frankness", "(and", "honesty?)", "of", "the", "Takeda", "statement.", "We", "realise", "we", "are", "hemmed", "in", "by", "a", "confidentiality", "clause,", "but", "does", "this", "have", "the", "endorsement", "of", "our", "senior", "management", ".", "Regards,", "Peter.", "tile", "-", "Takedy", "blogde", "fizone", "license", "ast", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065604", "Source:", "https://www.indupbydemoodonts.ucsf.edu/docs/sljf0226" ]
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null
1
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null
null
sljf0226_1.png
1,700
2,236
{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "THE UPJOHN COMPANY" ] }, { "answer_end": [ 29, 29 ], "answer_start": [ 27, 27 ], "text": [ "September 21, 1993", "september 21 , 1993" ] }, { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "THE UPJOHN COMPANY" ] }, { "answer_end": [ 8, 8 ], "answer_start": [ 8, 8 ], "text": [ "U.S.A", "USA" ] } ], "question": [ "what is the name of the company", "what is the date and year mentioned ?", "Which company is mentioned in the letterhead?", "in which country the upjohn company is located ?" ], "question_id": [ 1147, 1148, 1150, 1151 ] }
[ "TAKEDA", "Aat", "THE", "UPJOHN", "COMPANY", "KALAMAZOO,", "MICHIGAN", "49001-0199.", "U.S.A.", "TELEPHONE:", "(616)", "323-4000.", "J.", "R.", "MITCHELL,", "M.D.", "A.D.", "Vice", "Chairman", "of", "the", "Board", "TELEPHONE.", "(614)", "385-7053", "(816)", "385-5291", "September", "21,", "1993", "Tai", "Matsuzawa,", "Ph.D.", "Managing", "Director", "Vice", "President,", "Pharmaceutical", "Group", "Takeda", "Chemical", "Industries,", "Lid,", "1-1,", "Doshomachi", "4-Chome", "Chuo-Ku,", "Osaka", "541", "Japan", "Dear", "Doctor", "Matsuzawa:", "As", "you", "know,", "Upjohn", "has", "committed", "to", "notify", "Takeda", "by", "October", "1,", "1993,", "of", "our", "intentions", "regarding", "further", "clinical", "development", "of", "pioglitazone.", "On", "September", "20", "our", "Pharmaceutical", "Executive", "Council,", "Upjohn's", "highest", "scientific", "decision-making", "body,", "carefully", "reviewed", "the", "results", "of", "the", "toxicology", "and", "clinical", "studies.", "The", "decision", "of", "the", "Council", "was", "that", "Upjohn", "will", "not", "go", "forward", "with", "pioglitazone", "in", "the", "clinic.", "The", "Council", "decided", "that", "further", "clinical", "development", "of", "pioglitazone", "could", "not", "be", "justified", "based", "on", "their", "concern", "regarding", "pioglitazone's", "margin", "of", "safety.", "As", "a", "consequence", "of", "this", "decision,", "Upjohn", "also", "must", "decline", "participation", "with", "Takeda", "on", "the", "proposed", "pioglitazone", "study", "in", "Canada.", "It", "is", "with", "deep", "regret", "that", "I", "convey", "this", "message.", "As", "you", "know", "Upjohn", "and", "Takeda", "enjoy", "a", "strong", "and", "beneficial", "relationship", "based", "on", "mutual", "respect.", "It", "is", "a", "great", "disappointment", "to", "us", "that", "we", "will", "not", "have", "the", "opportunity", "of", "further", "interactions", "and", "collaboration", "with", "Takeda", "on", "this", "project.", "Hopefully,", "we", "will", "find", "other", "opportunities", "for", "collaboration", "in", "the", "future.", "I", "have", "instructed", "my", "staff", "to", "work", "closely", "with", "Takeda", "personnel", "in", "regards", "to", "the", "release", "of", "any", "information,", "data,", "FDA", "notifications,", "and", "other", "issues", "to", "ensure", "Takeda's", "interests", "and", "wishes", "are", "followed.", "With", "best", "personal", "regards,", "Sincerely,", "President,", "Upjohn", "Laboratories", "Worldwide", "Research,", "Development,", "&", "Medical", "Affairs", "CONFIDENTIAL", "-", "SUBJECT", "TO", "PROTECTIVE", "ORDER", "UPJ-0065603", "Source:", "https://www.indup606-oooo2ts.ucsf.edu/docs/zsjf0226" ]
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2
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null
zsjf0226_2.png
1,701
2,237
{ "answers": [ { "answer_end": [ 4 ], "answer_start": [ 2 ], "text": [ "06 6204 2244" ] }, { "answer_end": [ 7 ], "answer_start": [ 5 ], "text": [ "2002 08/08 21:49" ] }, { "answer_end": [ 14, 14 ], "answer_start": [ 12, 12 ], "text": [ "TAKEDA DEVELOP DIVISION", "Takeda Develop division" ] }, { "answer_end": [ 61 ], "answer_start": [ 61 ], "text": [ "FDA" ] } ], "question": [ "what is the fax mentioned ?", "what is year date and time mentioned?", "what is the name of the division ?", "to whom they can ask directly to disclose the details of \"promotion study\"?" ], "question_id": [ 1152, 1153, 1154, 1155 ] }
[ "08/07/2002", "18:46", "06", "6204", "2244", "2002", "08/08", "21:49", "FAX", "06", "6204", "2244", "TAKEDA", "DEVELOP", "DIVISION", "41", "003/006", "contact,", "what", "can", "we", "do?", "(7)", "As", "we", "point", "out", "in", "our", "action", "plan", "(see", "Action", "1,", "(1),", "iv),", "we", "can", "claim", "that", "the", "two-stage", "carcinogenicity", "model", "is", "considered", "to", "be", "too", "sensitive", "and", "likely", "to", "result", "in", "false", "positive.", "(8)", "We", "can", "ask", "FDA", "directly", "to", "disclose", "the", "details", "of", "\"promotion", "study\"", "and", "2-year", "carcinogenicity", "studies", "in", "our", "first", "response", "to", "FDA.", "It", "is", "not", "too", "late", "to", "think", "about", "a", "contact", "with", "NN", "after", "FDA's", "response", "to", "our", "first", "comments.", "[Conclusion]", "(1)", "Benefit<", "<Risk", "(2)", "This", "would", "not", "be", "the", "best", "moment", "to", "have", "a", "contact", "with", "NN.", "(3)", "We", "would", "better", "respond", "to", "FDA", "based", "on", "published", "papers,", "our", "data,", "NN's", "official", "comments", "on", "their", "homepage", "and", "the", "information", "that", "FDA", "gave", "TPNA", "about", "NN-622", "and", "pioglitazone", "and", "not", "on", "the", "information", "obtained", "from", "a", "contact", "with", "NN", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019746", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupbodocoooosts.ucsf.edu/docs/pljf0226" ]
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null
3
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null
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pljf0226_3.png
1,700
2,236
{ "answers": [ { "answer_end": [ 2, 2 ], "answer_start": [ 0, 0 ], "text": [ "8 January 2003", "8 january 2003" ] }, { "answer_end": [ 6 ], "answer_start": [ 4 ], "text": [ "MPDRAP I Leader" ] }, { "answer_end": [ 14, 14 ], "answer_start": [ 8, 8 ], "text": [ "CEOs and General Managers of Pharmaceutical Units", "CEOs and general managers of pharmaceutical units" ] }, { "answer_end": [ 221, 221 ], "answer_start": [ 221, 221 ], "text": [ "64", "64%" ] } ], "question": [ "what is the date mentioned in the letter", "To whom this letter is addressed?", "what is mentioned in the CC?", "combination therapy in the us market accounts for how much % of total actos sales ." ], "question_id": [ 1157, 1158, 1159, 1160 ] }
[ "8", "January", "2003", "To:", "MPDRAP", "I", "Leader", "cc:", "CEOs", "and", "General", "Managers", "of", "Pharmaceutical", "Units", "My", "Concerns", "about", "sNDA", "for", "Actos", "45mg", "in", "the", "USA", "(Reconfirmation)", "Pharmaceutical", "International", "Division", "Y.", "Narai", "I", "express", "my", "opinion", "about", "the", "conclusion", "drawn", "at", "MPDRAP", "Committee", "Meeting", "where", "it", "was", "agreed", "that", "sNDA", "to", "obtain", "the", "approval", "of", "the", "45mg", "combination", "indications", "would", "be", "submitted,", "as", "well", "as", "the", "safety", "update", "based", "on", "the", "commitment", "studies.", "As", "you", "know,", "Actos", "is", "the", "essential", "product", "for", "IPNA", "and", "is", "vital", "to", "the", "survival", "of", "TPNA.", "If", "unfavorable", "revisions", "in", "the", "Actos", "labeling", "are", "made,", "it", "invites", "the", "serious", "risk", "to", "Actos", "in", "the", "US.", "TPNA", "is", "now", "under", "attack", "from", "GSK,", "especially", "by", "Avandamet", "and", "is", "eager", "to", "maintain", "their", "market", "share.", "In", "addition", "to", "this", "attack,", "if", "the", "indications", "of", "Actos", "are", "reduced,", "TPNA", "is", "pushed", "into", "critical", "situation.", "This", "issue", "seriously", "damages", "not", "only", "US", "market", "but", "also", "Takeda's", "global", "strategy.", "Therefore,", "HQ", "should", "be", "extremely", "cautious", "about", "the", "issues", "related", "to", "Actos.", "If", "this", "sNDA", "raises", "the", "argument", "for", "the", "indications", "of", "Actos,", "for", "example,", "reductions", "in", "the", "indications,", "the", "issues", "will", "come", "to", "a", "critical", "path", "like", "as", "I", "mentioned.", "So", "we", "should", "go", "into", "action", "on", "condition", "that", "there", "is", "no", "such", "risk.", "Combination", "therapy", "in", "the", "US", "market", "accounts", "for", "64%", "of", "total", "Actos", "sales.", "(29%", "in", "combination", "with", "SU,", "27%", "Metformin", "and", "8%", "Insulin)", "Regarding", "the", "possibility", "of", "the", "risk", "of", "labeling", "revision,", "International", "Division", "entrusts", "Development", "Division", "with", "final", "decision.", "However,", "just", "to", "be", "sure,", "I", "would", "like", "to", "reconfirm", "that", "this", "sNDA", "dose", "not", "lead", "to", "a", "serious", "situation.", "I", "heard", "that", "TPNA", "R&D", "suggested", "to", "HQ", "and", "is", "getting", "ready", "for", "sNDA", "for", "the", "45mg", "combination", "indications.", "However,", "HQ", "should", "carefully", "judge", "whether", "this", "sNDA", "should", "be", "submitted", "to", "the", "FDA", "or", "not.", "I", "think", "that", "sNDA", "for", "efficacy", "should", "be", "submitted", "only", "when", "there", "is", "no", "risk", "that", "this", "sND", "A", "damages", "the", "current", "labeling.", "According", "to", "the", "results", "of", "PNFP-343,", "combination", "with", "insulin,", "edema", "was", "observed", "more", "often", "than", "Avandia,", "which", "dose", "not", "have", "the", "indication", "for", "combination", "with", "insulin", "and", "CHF", "in", "this", "study", "seems", "to", "be", "dose", "related.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00005583", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupt2290-coots.ucsf.edu/docs/syjf0226" ]
null
null
1
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null
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syjf0226_1.png
1,700
2,236
{ "answers": [ { "answer_end": [ 23 ], "answer_start": [ 22 ], "text": [ "August 5" ] }, { "answer_end": [ 21, 21 ], "answer_start": [ 20, 20 ], "text": [ "Amy Hagaman", "Amy hagaman" ] }, { "answer_end": [ 80, 80 ], "answer_start": [ 79, 79 ], "text": [ "August 12", "august 12" ] }, { "answer_end": [ 107, 107 ], "answer_start": [ 105, 105 ], "text": [ "August 1, 2002", "august 1, 2002" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "Amy Hagaman/Alfonso Perez" ] }, { "answer_end": [ 111 ], "answer_start": [ 111 ], "text": [ "7" ] } ], "question": [ "What is the due date to evaluate data from actos 507?", "who is the lead responsibility for developing additional monitoring plan for actos 508", "what is the due date for \"draft justification for actos 508\" ?", "when was this last updated ?", "Who is the lead responsible person for draft justification for actos 508?", "How many pages are there in total as part of this document?" ], "question_id": [ 1177, 1178, 1179, 1180, 1181, 1231 ] }
[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "4.", "PEDIATRIC", "STUDIES", "(CONTINUED)", "Evaluate", "data", "from", "Actos", "507", ">", "Evaluate", "data", "to", "support", "Amy", "Hagaman", "August", "5", "ustification", "to", "proceed", "with", "Actos", "508", "Develop", "additional", "monitoring", "Amy", "Hagaman", "plan", "for", "Actos", "508", "Evaluate", "feasibility/business", "T.", "Muldoon", "case", "of", "request", "to", "FDA", "to", "delay", "start", "of", "Actos", "50", "M", "Ramstack", "pending", "Actos", "506", "data;", "J", "Haskins", "assess", "impact", "on", "pediatric", "exclusivity/patent", "Draft", "justification", "for", "Actos", "508", ",", ">", "Justification", "should", "be", "Amy", "Hagaman/Alfonso", "August", "12", "based", "on", "rebuttal", "of", "FDA", "Pere", "hypothesis", "regarding", "mechanism", "of", "action", "for", "bladder", "cancer", "and", "addition", "of", "clinical", "monitoring", "plan", "to", "protocol", "Last", "Update:", "August", "1,", "2002", "Page", "3", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMEL-00032212", "Produced", "in", "MDL", "on", "02/21/13-", "Source:", "https://www.indupssiscoboots.ucsf.edu/docs/qtjf0226" ]
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null
4
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{ "answers": [ { "answer_end": [ 7, 7 ], "answer_start": [ 5, 5 ], "text": [ "20 April 2006", "20 april 2006" ] }, { "answer_end": [ 11 ], "answer_start": [ 9 ], "text": [ "4:00pm - 5:00pm" ] }, { "answer_end": [ 17, 17 ], "answer_start": [ 15, 15 ], "text": [ "Meeting Room 403", "meeting room 403" ] }, { "answer_end": [ 62 ], "answer_start": [ 62 ], "text": [ "Mondira" ] }, { "answer_end": [ 109 ], "answer_start": [ 107 ], "text": [ "in early May" ] } ], "question": [ "what is the date mentioned in the given information ?", "What is the meeting time mentioned here?", "what is the place mentioned ?", "who will forward the article regarding rosiglitazone and non clinical bladder data to andy ?", "What date is the meeting scheduled to develop the overall structure of the document?" ], "question_id": [ 1198, 1199, 1200, 1202, 1203 ] }
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null
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nqjf0226_1.png
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{ "answers": [ { "answer_end": [ 18 ], "answer_start": [ 17 ], "text": [ "Philip Collett" ] }, { "answer_end": [ 50 ], "answer_start": [ 42 ], "text": [ "Raising the pH of male rat urine above 6.5" ] }, { "answer_end": [ 77 ], "answer_start": [ 77 ], "text": [ "0.61" ] }, { "answer_end": [ 61, 61 ], "answer_start": [ 58, 58 ], "text": [ "Because rats are quadropeds", "Because rats are quadropeds." ] }, { "answer_end": [ 151 ], "answer_start": [ 150 ], "text": [ "Takeda Europe" ] }, { "answer_end": [ 33, 34 ], "answer_start": [ 33, 33 ], "text": [ "protein", "protien content" ] } ], "question": [ "Who presented an outline of the Cohen hypothesis?", "What is significant in the development of calculi?", "What is the correlation observed in cohen's paper?", "Why didn't rats eliminate calculi as humans do?", "Who challenged authorities regrading implementing monitoring plan?", "What content is high in male rat urine?" ], "question_id": [ 1204, 1205, 1206, 1207, 1233, 1234 ] }
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{ "answers": [ { "answer_end": [ 91 ], "answer_start": [ 90 ], "text": [ "Mr. Saito" ] }, { "answer_end": [ 185, 185 ], "answer_start": [ 184, 183 ], "text": [ "August 19", "by August 19" ] }, { "answer_end": [ 195, 195 ], "answer_start": [ 194, 193 ], "text": [ "August 20", "on August 20" ] }, { "answer_end": [ 215, 215 ], "answer_start": [ 214, 213 ], "text": [ "August 26", "by August 26" ] } ], "question": [ "Who updated the CEO on August 6?", "By when should TPNA send outline of response to TCI ?", "When will Mr. Saito present outline to CEO?", "By when will the document be finalized?" ], "question_id": [ 1215, 1216, 1217, 1218 ] }
[ "ACTOS", "FDA", "Response", "Meeting", "August", "12-13,", "2002", "Page", "2", "of", "4", "Summary", "of", "July", "31", "Teleconference", "with", "FDA", "(J.", "Haskins)", "-", "Continued", ">", "The", "group", "summarized", "the", "FDA's", "concerns", "as", "follows:", ">", "The", "FDA", "is", "not", "stating", "that", "ACTOS", "specifically", "causes", "or", "contributes", "to", "bladder", "tumors.", "The", "FDA", "no", "longer", "supports", "Dr.", "Cohen's", "hypothesis,", "since", "the", "tumor", "promoter", "study", "data", "they", "received", "demonstrated", "the", "presence", "of", "tumors", "without", "calculi.", ">", "The", "FDA", "no", "longer", "feels", "that", "they", "understand", "how", "these", "findings", "relate", "to", "humans.", "Update", "from", "TCI", "Meeting", "with", "CEO", "(Mr.", "Saito)", "Mr.", "Saito", "updated", "the", "CEO", "on", "this", "situation", "on", "August", "6.", "The", "following", "strategy", "was", "decided", "on:", ">", "Attempt", "to", "keep", "current", "carcinogenicity", "label", "wording;", "if", "not", "possible,", "request", "that", "same", "labeling", "be", "applied", "to", "Avandia", ">", "Find", "rationale", "to", "support", "not", "establishing", "monitoring", "plan,", "but", "if", "necessary,", "would", "compromise", "on", "monitoring", "wording", "to", "avoid", "changing", "carcinogenicity", "wording", "Develop", "argument", "to", "proceed", "with", "Actos", "508", "(safety/efficacy", "in", "pediatrics)", "study", "under", "current", "timelines,", "but", "are", "willing", "to", "postpone", ">", "The", "following", "timelines", "were", "established:", "TPNA", "to", "send", "outline", "of", "response", "to", "TCI", "by", "August", "19", "Mr.", "Saito", "will", "present", "outline", "to", "CEO", "on", "August", "20", "TPNA", "will", "send", "draft", "document", "to", "TCI,", "TEUR&D,", "and", "Lilly", "on", "August", "21", "Document", "will", "be", "finalized", "by", "August", "26", "Response", "will", "be", "sent", "to", "FDA", "on", "August", "28", ">", "Mr", "Saito", "also", "presented", "the", "following", "communication", "structure", "and", "schematic", "Leadership:", "Claire", "Thom,", "David", "Eckland,", "Mr.", "Saito", ">", "Primary", "contacts:", "Mary", "Ramstack,", "Janet", "Haskins,", "Philip", "Collett,", "Mr.", "Miyazaki", ">The", "only", "exception", "to", "this", "schematic", "will", "be", "that", "on", "August", "26,", "TPNA", "will", "communicate", "directly", "with", "Lilly", "to", "distribute", "the", "draft", "document", "CEO", "Mr", "Saito", "-", "TPNA", "TCI", "labs", "Lilly", "FU", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487174", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indusp2/phg", "oooops.ucsf.edu/docs/myjf0226" ]
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{ "answers": [ { "answer_end": [ 6, 6 ], "answer_start": [ 4, 4 ], "text": [ "august 13, 2002", "August 13, 2002" ] }, { "answer_end": [ 25, 25 ], "answer_start": [ 24, 24 ], "text": [ "David baron", "David Baron" ] }, { "answer_end": [ 70, 70 ], "answer_start": [ 69, 69 ], "text": [ "dr. el-hage", "Dr. El-Hage" ] }, { "answer_end": [ 271, 273 ], "answer_start": [ 271, 271 ], "text": [ "32-weeks", "32-weeks after BBN." ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "107" ] } ], "question": [ "What is the issued date of this document?", "Who is the Director of Nonclinical Safety and Efficacy?", "Who described tumor promoter-model study?", "What is the duration of daily dosing?", "What is the exhibit number?" ], "question_id": [ 1211, 1212, 1213, 1214, 1260 ] }
[ "107", "FDA", "Conference", "Call:", "August", "13,", "2002", "PENGAD", "800-631-698", "EXHIBIT", "FDA", "Personnel:", "Jeri", "El-Hage,", "Ph.D.,", "Toxicology", "Team", "Leader", "Jena", "Weber,", "Project", "Manager", "TPNA", "Personnel:", "David", "Baron,", "Ph.D.,", "Director,", "Nonclinical", "Safety", "and", "Efficacy", "Janet", "Haskins,", "Manager,", "Regulatory", "Affairs", "Pat", "Frank,", "Ph.D.,", "TPNA", "Consultant", "This", "teleconference", "was", "held", "as", "a", "follow-up", "to", "a", "discussion", "between", "TPNA", "and", "the", "Agency", "on", "July", "31,", "2002.", "The", "purpose", "of", "this", "call", "was", "so", "that", "Dr.", "El-Hage", "could", "expand", "upon", "the", "nonclinical", "data", "related", "to", "dual", "PPAR", "agonists", "that", "were", "discussed", "with", "TPNA", "on", "July", "31,", "2002.", "Dr.", "El-Hage", "informed", "TPNA", "that", "in", "standard", "2-year", "rat", "and", "mouse", "bioassay", "studies,", "several", "other", "dual", "PPAR", "agonists", "were", "shown", "to", "cause", "transitional", "cell", "tumors", "in", "the", "bladder", "and", "kidneys", "of", "male", "and", "female", "rats", "and", "male", "mice.", "Therefore,", "the", "Division", "is", "considering", "the", "relevance", "of", "these", "findings", "to", "this", "pharmaceutical", "class", "of", "drugs.", "She", "also", "noted", "that", "in", "follow-up", "unspecified", "mechanistic", "studies", "of", "the", "other", "dual", "PPAR", "agonists,", "no", "evidence", "of", "irritation", "by", "crystalluria", "or", "calculi", "was", "noted.", "Dr.", "El-Hage", "then", "described", "a", "tumor", "promoter-model", "study", "that", "was", "conducted", "by", "another", "sponsor", "in", "which", "pioglitazone", "was", "administered.", "The", "study", "was", "designed", "as", "follows:", ".", "BBN", "was", "given", "to", "male", "Fisher", "rats", "in", "their", "drinking", "water", "for", "four", "weeks.", "Four", "groups", "were", "designated:", ".", "Pioglitazone", "40", "mg/kg/day", "after", "BBN", "The", "study", "compound", "plus", "BBN", "(No", "dosages", "were", "specified,", "but", "Dr.", "El-Hage", "noted", "that", "multiple", "dosages", "were", "studied", "and", "the", "high", "dose", "was", "designed", "to", "be", "\"equivalent\"", "to", "40", "mg/kg", "pioglitazone", ")", "The", "negative", "control", "group", "received", "BBN", "only.", ".", "The", "positive", "control", "group", "received", "uracil.", "Duration", "of", "daily", "dosing", "was", "32-weeks", "after", "BBN.", "Results:", ".", "85%", "of", "the", "animals", "in", "the", "pioglitazone", "and", "the", "other", "sponsor's", "compound", "groups", "had", "tumor", "formation.", "Calculi", "formation", "was", "not", "confirmed", "in", "either", "group,", "but", "was", "looked", "for", "using", "unspecified", "methodology", "15%", "of", "the", "animals", "in", "the", "negative", "control", "group", "had", "tumor", "formation,", "while", "approximately", "50%", "of", "the", "positive", "control", "group", "presented", "tumors", "in", "the", "presence", "of", "calculi", "formation", "(uracil).", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-NAUGHP-00080811", "Source:", "https://www.indup53720boots.ucsf.edu/docs/jsjf0226" ]
null
null
1
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jsjf0226_1.png
1,700
2,236
{ "answers": [ { "answer_end": [ 61, 61 ], "answer_start": [ 59, 59 ], "text": [ "Pharmaceutical development Division", "Pharmaceutical Development Division" ] }, { "answer_end": [ 24 ], "answer_start": [ 23 ], "text": [ "Dr. Kitazawa" ] }, { "answer_end": [ 229, 229 ], "answer_start": [ 225, 226 ], "text": [ "for October 1 and 2.", "October 1 and 2" ] }, { "answer_end": [ 285, 285 ], "answer_start": [ 281, 281 ], "text": [ "to address the bladder issue", "to address the bladder issue." ] }, { "answer_end": [ 3, 3 ], "answer_start": [ 2, 2 ], "text": [ "Assistant manager", "Assistant Manager" ] } ], "question": [ "Which is the core organization of Takeda pharmaceutical Company?", "Who made the opening remarks ?", "When is the clinical expert meeting scheduled?", "Why was it suggested to prepare non-clinical \"White paper\"?", "What is Ms Wakamatsu's role in Dept. Strategic Development?" ], "question_id": [ 1195, 1196, 1197, 1201, 1229 ] }
[ "Ms.", "Wakamatsu,", "Assistant", "manager,", "Dept.", "Strategic", "Development,", "et", "al.", "Attachment:", "NDA", "schedule", "for", "each", "project", "approved", "on", "the", "5th", "GDC", "1.", "Openings", "Remarks", "Dr.", "Kitazawa", "made", "opening", "remarks.", "He", "mentioned", "that", "TAKEDA", "has", "been", "driving", "for", "to", "be", "a", "global", "pharmaceutical", "company", "in", "this", "decade,", "concentrating", "all", "resource", "into", "the", "pharmaceutical", "business,", "under", "the", "clear-cut", "leadership", "of", "the", "CEO.", "Pharmaceutical", "Development", "Division", "is", "a", "core", "organization", "of", "Takeda", "Pharmaceutical", "Company,", "enhancing", "the", "pipeline", "products,", "which", "is", "the", "decisive", "factor", "for", "TAKEDA", "business.", "However,", "in", "the", "present", "condition,", "since", "the", "launch", "of", "Actos", "in", "1999", "there", "are", "no", "new", "products", "launched.", "While", "this", "situation", "is", "critical,", "the", "Pharmaceutical", "Development", "Division", "is", "thought", "to", "be", "conservative", "and", "lack", "of", "challenging", "spirit.", "He", "stated", "that", "his", "mission", "is", "to", "improve", "this", "conservative", "atmosphere", "and", "grow", "challenging", "spirit", "to", "develop", "and", "launch", "the", "new", "products", "earlier", "than", "scheduled.", "Formatted:", "Not", "Hidden", "3.", "MPDRAP-I", "(Diabetes)", "1)", "AD-4833", "Update", "of", "US", "status", "by", "TPNA", "Bladder", "tumor", "observed", "in", "NN622", "study", "As", "for", "the", "bladder", "issues,", "an", "expected", "response", "from", "FDA", "is", "in", "early", "October", "and", "pediatric", "study", "(Actos", "508)", "is", "temporarily", "on", "hold,", "however,", "this", "is", "not", "an", "official", "hold.", "In", "the", "recent", "teleconference", "discussing", "non-clinical", "issues,", "the", "experts", "could", "not", "identify", "any", "rational", "hypothesis", "that", "dual", "PPAR", "agonists", "may", "be", "linked", "to", "bladder", "tumogenesis.", "A", "clinical", "expert", "meeting", "is", "scheduled", "for", "October", "1", "and", "2", "to", "discuss", "how", "to", "screen/monitor", "bladder", "tumors", "in", "long-term", "clinical", "trials,", "since", "FDA", "may", "force", "TPNA", "to", "do", "it.", "Label", "changes", "may", "be", "requested", "by", "FDA", "and", "it", "is", "very", "difficult", "to", "assess", "the", "marketing", "impact", "of", "such", "label", "change", "at", "this", "moment.", "It", "was", "suggested", "to", "prepare", "non-clinical", "\"White", "paper\"", "to", "address", "the", "bladder", "issue.", "US", "commitment", "study", "of", "30mg", "vs.", "45mg", "An", "SNDA", "will", "be", "submitted", "in", "this", "autumn,", "where", "studies", "341,", "342,", "343", "and", "513", "are", "included.", "The", "objectives", "of", "the", "submission", "are", "for", "1)", "a", "safety", "purpose,", "not", "for", "an", "efficacy", "or", "new", "indication", "of", "45mg,", "and", "2)", "an", "update", "of", "oral", "contraceptive", "interaction", "results", "in", "the", "label.", "Timelines", "and", "issues", "on", "Actos", "combination", "projects", "were", "presented.", "Actos-Metformin", "Convenience", "Pack", "is", "expected", "to", "file", "sNDA", "in", "March", "2003", "and", "to", "be", "approved", "in", "September", "2003.", "TPNA", "believes", "stability", "data", "of", "3", "months", "are", "sufficient", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00012574", "Source:", "https://www.indupto442coo02ts.ucsf.edu/docs/Imjf0226", "Produced", "in", "MDL", "on", "09/14/12" ]
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lmjf0226_2.png
1,700
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{ "answers": [ { "answer_end": [ 54, 54 ], "answer_start": [ 45, 45 ], "text": [ "pioglitazone: need to commit to studies to investigate certain signals", "Pioglitazone: Need to commit to studies to investigate certain signals" ] }, { "answer_end": [ 210, 210 ], "answer_start": [ 210, 210 ], "text": [ "usa", "USA" ] }, { "answer_end": [ 306, 306 ], "answer_start": [ 296, 296 ], "text": [ "tgrd would formulate direct risk management plan and obtain japan's input", "TGRD would formulate direct Risk Management plan and obtain Japan's input" ] }, { "answer_end": [ 168 ], "answer_start": [ 166 ], "text": [ "prescription event monitoring" ] } ], "question": [ "What is the Specific example given?", "Which country would have similar interest as in Europe?", "What is the Suggestion from Glyn?", "Full form of PEM?" ], "question_id": [ 1347, 1349, 1351, 1353 ] }
[ "4)", "Marketing", ">", "6", "monthly", "PSUR's", ".", "In", "the", "future,", "risk", "management", "plan", "will", "be", "reviewed", "to", "see", "how", "much", "of", "the", "safety", "signals", "have", "been", "clarified.", "Will", "include", "not", "just", "listings", "of", "events", "but", "more", "figures.", "Risk", "has", "to", "be", "clearly", "stated.", "Specific", "examples:", "Pioglitazone:", "Need", "to", "commit", "to", "studies", "to", "investigate", "certain", "signals", "1)", "Bladder", "Cancer", "in", "Rats", ">", "further", "epidemiologic", "study", "and", "pre-clinical", "investigations", "as", "part", "of", "license", "application", "Preclinical", "investigations", "done", "within", "TCI", "(Osaka).", "Some", "preclinical", "investigations", "are", "contracted", "out", "ie,", "to", "U", "of", "Nebraska", "which", "submits", "protocols", "but", "doesn't", "do", "actual", "work.", "Epi", "study:", "case", "control", "study:", "use", "retrospective", "data", "from", "general", "practitioners", "database.", "Other", "epi", "studies", "prospective", "case", "cohort", "study,", "epi", "studies", "tagging", "people", "who", "receive", "the", "drug", "and", "compare", "results", "with", "historical", "data", "2)", "Fluid", "Retention/CHF", "/Cardiac", "hypertrophy->", "mechanistic", "studies", "will", "be", "conducted.", "As", "part", "of", "license", "application,", "studies", "in", "CHF", "patients", "+", "outcome", "studies", "were", "requested,", "Safety", "signals", "will", "be", "clarified", "using", "these", "studies", "3)", "Liver", "problem->", "PEM", "(prescription", "event", "monitoring)", "study", "similar", "to", "Japanese", "post.", "event", "marketing", "study.", "Prescribing", "doctor's", "name", "and", "patient's", "name", "are", "recorded", "in", "a", "central", "database", "from", "beginning", "of", "marketing.", "This", "database", "is", "reviewed", "for", "signals", "US", "Perspective", "Cal", "McNeill", "Discussion:", "Regulators", "will", "have", "similar", "interest", "in", "USA", "as", "in", "Europe:", "FDA", "expects", "sponsors", "to", "become", "proactive", "around", "safety", "issues", "from", "pre-clinical", "data", "to", "marketing", "phase", "Incorporate", "RM", "strategies", "in", "NDA", "submissions", "which", "is", "not", "the", "case", "at", "the", "moment", "but", "will", "begin", "incorporating", "risk", "management", "strategies", "for/", "with", "Ramelteon.", "minimize", "risk", "throughout", "product's", "life-cylce", "o", "guidance", "from", "FDA", "expected", "in", "September", "2004", "Risk", "Management", "-", "component", "of", "comprehensive", "product", "stewardship", "pre-market/", "clinical", "development", "post-marketing", "General", "Discussion", "ALL", "Question", "1", "-", "Japan's", "role", "in", "RM;", "Who", "will", "direct", "company's", "position?", "Suggestion", "from", "Glyn:", "TGRD", "would", "formulate", "direct", "Risk", "Management", "plan", "and", "obtain", "Japan's", "input,", "`Takeda", "Forum", "Risk", "Management", "March", "22,", "2004", "2", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-BAROND-00208932", "Produced", "in", "MDL", "on", "09/02/12", "Source:", "https://www.induspop56-00602s.ucsf.edu/docs/gmjf0226" ]
null
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2
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{ "answers": [ { "answer_end": [ 10 ], "answer_start": [ 8 ], "text": [ "July 31, 2002" ] }, { "answer_end": [ 140, 105 ], "answer_start": [ 140, 105 ], "text": [ "3", "3 topics" ] }, { "answer_end": [ 331 ], "answer_start": [ 331 ], "text": [ "09/18/12" ] } ], "question": [ "When will the FDA Conference Call be held?", "On the purpose of teleconference, how many topics were to be discussed?", "What is the date mentioned at the bottom?" ], "question_id": [ 1219, 1357, 1359 ] }
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{ "answers": [ { "answer_end": [ 6 ], "answer_start": [ 2 ], "text": [ "ACTOS FDA RESPONSE TASK FORCE-TPNA" ] }, { "answer_end": [ 62, 50 ], "answer_start": [ 47, 50 ], "text": [ "The FDA has 3 key issues with respect to the non-clinical data related to bladder tumors.", "3" ] }, { "answer_end": [ 117, 109 ], "answer_start": [ 113, 108 ], "text": [ "TPNA will develop monitoring plan.", "monitoring plan" ] }, { "answer_end": [ 187 ], "answer_start": [ 179 ], "text": [ "is to supply justification to support maintaining current labeling." ] } ], "question": [ "What is the heading of the document?", "How many key issues does the FDA have with respect to the non-clinical data related to bladder tumors?", "What plan is developed by TPNA?", "What is TPNA's goal?" ], "question_id": [ 1220, 1221, 1222, 1223 ] }
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{ "answers": [ { "answer_end": [ 206 ], "answer_start": [ 204 ], "text": [ "Marketing Authorization Application" ] }, { "answer_end": [ 5, 8 ], "answer_start": [ 2, 2 ], "text": [ "Takeda Global Risk Management Forum", "Takeda Global Risk Management Forum/March 22, 2004" ] } ], "question": [ "What is the fullform of MAA?", "Which forum is mentioned in this document?" ], "question_id": [ 1208, 1209 ] }
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{ "answers": [ { "answer_end": [ 89 ], "answer_start": [ 87 ], "text": [ "August 1, 2002" ] }, { "answer_end": [ 84, 84 ], "answer_start": [ 81, 81 ], "text": [ "Evaluate Impact on Tak-559", "EVALUATE IMPACT ON TAK-559" ] }, { "answer_end": [ 38 ], "answer_start": [ 37 ], "text": [ "August 5" ] } ], "question": [ "When was this document last updated?", "What is the last point in the table?", "What is the Draft's Due Date?" ], "question_id": [ 1224, 1225, 1227 ] }
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{ "answers": [ { "answer_end": [ 3 ], "answer_start": [ 0 ], "text": [ "ACTOS FDA RESPONSE MEETING" ] }, { "answer_end": [ 91, 91 ], "answer_start": [ 91, 91 ], "text": [ "Pioglitazone", "pioglitazone" ] }, { "answer_end": [ 110, 112 ], "answer_start": [ 110, 110 ], "text": [ "transitional", "transitional cell tumors" ] } ], "question": [ "What kind of meeting is mentioned in this letter?", "what kind of drug is used to treat the group of rats?", "what kind of cell tumours experienced the same frequency when group of rats treated with pioglitazone?" ], "question_id": [ 1235, 1239, 1245 ] }
[ "ACTOS", "FDA", "RESPONSE", "MEETING", "TPNA/TEUR&D/TCI", "AUGUST", "12-13,", "2002", "Attendees:", "TPNA", "TEUR&D", "Sam", "Hamanaka", "David", "Eckland", "Claire", "Thom", "Yasuhiko", "Wada", "Ingrid", "Hood", "Glyn", "Belcher", "Alfonso", "Perez", "Philip", "Collett", "David", "Recker", "John", "Page", "TCI", "Mary", "Ramstack", "Katsuhisa", "Saito", "Janet", "Haskins", "Masahiro", "Miyazaki", "Dan", "Orlando", "Takashi", "Kuroiwa", "David", "Baron", "Takashi", "Nonoyama", "Chris", "Durack", "Keiichiro", "Sato", "Larry", "Hancock", "Hiroyuki", "Odaka", "Bob", "Ahlbrandt", "Tom", "Muldoon", "Karen", "Kaluzny", "Summary", "of", "July", "31", "Teleconference", "with", "FDA", "(J.", "Haskins)", ">", "The", "FDA", "informed", "TPNA", "that", "they", "had", "received", "data", "from", "a", "rat", "tumor", "promoter", "study", "using", "dual", "PPAR", "agonists.", "Pioglitazone", "was", "used", "in", "this", "experiment,", "and", "the", "group", "of", "rats", "treated", "with", "pioglitazone", "experienced", "the", "same", "frequency", "of", "transitional", "cell", "tumors", "as", "the", "group", "treated", "with", "the", "dual", "PPAR", "agonist", "under", "investigation.", "The", "FDA", "clarified", "that", "due", "to", "this", "data,", "they", "had", "concerns", "with", "the", "dual", "PPAR", "mechanism,", "and", "considered", "pioglitazone", "to", "have", "a", "dual", "PPAR", "mechanism.", ">", "There", "were", "three", "key", "messages", "from", "the", "teleconference:", "The", "FDA", "asked", "TPNA", "to", "consider", "a", "label", "change,", "as", "they", "feel", "that", "the", "current", "package", "insert", "does", "not", "adequately", "inform", "patients", "of", "the", "risk", "associated", "with", "bladder", "tumors.", "The", "FDA", "asked", "TPNA", "to", "research", "and", "propose", "a", "monitoring", "plan,", "which", "would", "be", "incorporated", "into", "clinical", "trials.", "The", "FDA", "stated", "that", "they", "were", "considering", "rescinding", "their", "written", "request", "to", "TPNA", "to", "conduct", "pediatric", "studies", "with", "pioglitazone.", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487173", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indup2/Thgoood", "ts.ucsf.edu/docs/myjf0226" ]
null
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1
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null
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myjf0226_1.png
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{ "answers": [ { "answer_end": [ 47 ], "answer_start": [ 46 ], "text": [ "August 22" ] }, { "answer_end": [ 27 ], "answer_start": [ 26 ], "text": [ "Larry Hancock" ] }, { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "Send nonclinical rationale/justification section to medical writing for compilation", "Send nonclinical rationale/justification section to medical writing for compilation." ] }, { "answer_end": [ 36 ], "answer_start": [ 35 ], "text": [ "Mary Ramstack" ] }, { "answer_end": [ 54 ], "answer_start": [ 53 ], "text": [ "August 26" ] }, { "answer_end": [ 89, 89 ], "answer_start": [ 87, 87 ], "text": [ "August 1, 2002", "August 1, 2002" ] } ], "question": [ "What is the due date to conduct review meeting for FDA package?", "Who is the lead responsible person for the compilation of FDA package?", "What is the task assigned to David Baron?", "Who is responsible for sending package to TCI/EU for review?", "What is the due date for sending FDA Document to Regulatory Affairs?", "What is the last updated date mentioned in this document?" ], "question_id": [ 1241, 1243, 1247, 1248, 1249, 1251 ] }
[ "Task", "Notes", "Lead", "Responsibility", "Due", "Date", "6.", "INTRODUCTORY/CONCLUSION", "STATEMENTS", "(CONTINUED)", "Send", "nonclinical", "David", "Baron", "August", "20", "rationale/justification", "section", "to", "medical", "writing", "for", "compilation", "Compile", "FDA", "package", "Larry", "Hancock", "August", "21", "Send", "package", "to", "TCI/EU", "for", "Mary", "Ramstack", "August", "21", "review", "Conduct", "review", "meeting", "for", "Janet", "Haskins/Team", "August", "22", "FDA", "package", "FDA", "Document", "to", "August", "26", "Regulatory", "Affairs", "7.", "PACKAGE", "INSERTS/INFORMED", "CONSENT", "VERBIAGE", "Request", "NN622", "literate", "Janet", "Haskins", "August", "1", "-", "DONE", "searches.", "Identify", "package", "inserts", "with", "Janet", "Haskins", "August", "12", "similar", "class-related", "issues", "(T.e.,", "ACE-inhibitors)", "Last", "Update:", "August", "1,", "2002", "Page", "6", "of", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00032215", "Produced", "in", "MDL", "on", "02/21/1", "Source:", "https://www.indup538coo097ts.ucsf.edu/docs/qtjf0226" ]
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null
7
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qtjf0226_7.png
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{ "answers": [ { "answer_end": [ 31 ], "answer_start": [ 23 ], "text": [ "thickening of the bladder and hypertrophy of the urothelium" ] }, { "answer_end": [ 86 ], "answer_start": [ 83 ], "text": [ "shorter term (12 month)" ] }, { "answer_end": [ 59 ], "answer_start": [ 59 ], "text": [ "hyperplasia" ] }, { "answer_end": [ 181 ], "answer_start": [ 181 ], "text": [ "TCI" ] } ], "question": [ "In the rat oncogenicity study, what was observed in male rats?", "What is the time span where no tumors are seen?", "According to mouse oncogenicity study, what was seen male mice only?", "who conducted robust program?" ], "question_id": [ 1240, 1242, 1244, 1246 ] }
[ "ACTOS", "FDA", "Response", "Meeting", "August", "12-13,", "2002", "Page", "3", "of", "4", "Highlights/", "Discussion", "Points", "from", "Preclinical", "Data", "Presentation", "In", "the", "rat", "oncogenicity", "study,", "thickening", "of", "the", "bladder", "and", "hypertrophy", "of", "the", "urothelium", "was", "observed", "in", "male", "rats.", "These", "findings", "were", "not", "dose-", "dependent.", "Nearly", "all", "of", "the", "tumors", "were", "found", "at", "the", "end", "of", "the", "study", "Some", "cases", "of", "hyperplasia", "were", "seen", "in", "female", "rats", "at", "the", "highest", "dose", "level", "only,", "but", "no", "malignancies", "were", "seen.", "There", "were", "no", "tumors", "seen", "in", "the", "shorter", "term", "(12", "month)", "rat", "toxicity", "studies.", "Glyn", "Belcher", "suggested", "creating", "a", "summary", "able", "for", "all", "toxicology", "studies", "with", "durations", "between", "6", "months", "and", "less", "than", "2", "years.", "In", "the", "mouse", "oncogenicity", "study,", "hyperplasia", "was", "seen", "in", "male", "mice", "only.", "These", "findings", "were", "not", "dose-dependent,", "and", "results", "were", "not", "statistically", "significant.", "One", "case", "of", "hyperplasia", "was", "observed", "in", "the", "placebo", "group.", "Philip", "Collett", "stated", "that", "the", "European", "authorities", "did", "not", "question", "the", "mouse", "data", "for", "ACTOS,", "but", "rather", "only", "the", "rat", "data.", "A", "list", "of", "all", "mutagenicity", "studies", "conducted", "with", "pioglitazone", "was", "shown,", "and", "David", "Baron", "acknowledged", "that", "TCI", "had", "conducted", "a", "very", "robust", "program", "that", "went", "beyond", "regulatory", "requirements.", "A", "study", "observing", "the", "effects", "of", "pioglitazone", "on", "urinary", "parameters", "in", "rats", "was", "conducted,", "and", "highlights", "are", "as", "follows:", "Simple", "hyperplasia", "seen", "in", "one", "male", ">", "Increase", "in", "urine", "pH,", "urine", "volume,", "microcrystal", "count", "Slight", "decrease", "in", "magnesium,", "calcium,", "phosphorous,", "sodium,", "potassium,", "and", "chloride", "Conclusion:", "Changes", "in", "urinary", "components", "are", "considered", "to", "be", "factors", "in", "the", "etiology", "of", "proliferative", "lesions", "of", "the", "bladder:", "Pioglitazone", "ingestion", "Altered", "urinary", "physiology", "Calculus", "formation", "Urothelial", "ulceration", "an", "regeneration", "(hyperplasia)", "Benin", "papilloma", "Carcinoma", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-RAMSTM-00487175", "Produced", "in", "MDL", "on", "03/06/13", "Source:", "https://www.indusp2/phg", "oooogs.ucsf.edu/docs/myjf0226" ]
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myjf0226_3.png
1,701
2,237
{ "answers": [ { "answer_end": [ 54 ], "answer_start": [ 52 ], "text": [ "Professor Ele Ferrannini" ] }, { "answer_end": [ 83, 72 ], "answer_start": [ 81, 70 ], "text": [ "15th October 2005", "15 October 2005" ] }, { "answer_end": [ 0, 0, 13 ], "answer_start": [ 0, 0, 11 ], "text": [ "Monday 28th November 2005", "monday 28th november 2005", "28th November 2005" ] } ], "question": [ "Mention the first name listed in the \"apologies\"?", "when was the last meeting/conference call held on ?", "what is the date mentioned under the title - \" minutes of conference call\"?" ], "question_id": [ 1255, 1259, 1262 ] }
[ "PROactive'", "Executive", "Committee", "Conference", "Call", "Minutes", "of", "Conference", "Call", "Date:", "Monday", "28\"", "November", "2005", "EXHIBIT", "NO.", "Time:", "1900", "hours", "In", "attendance:", "Professor", "Erland", "Erdmann", "(EE)", "rmandy", "(JD)", "Professor", "Bernard", "Charbonnel", "(BC)", "Professor", "Massimo", "Massi-Benedetti", "(MMB)", "Mr", "lan", "Moules", "(IM)", "Dr", "Alfonso", "Perez", "(AP)", "Mrs", "Lucy", "Bennett", "(LB)", "Dr", "Susan", "Crawford", "(SC)", "Apologies:", "Professor", "Ele", "Ferrannini", "Dr", "Allan", "Skene", "Dr", "Meng", "Tan", "Professor", "Robert", "Wilcox", "1.", "Minutes", "of", "last", "meeting/conference", "call", "(15", "October", "2005)", "Minutes", "of", "the", "last", "meeting/conference", "call", "held", "on", "15\"", "October", "2005", "were", "accepted.", "The", "EC", "stressed", "that", "it", "has", "been", "recorded", "in", "minutes", "of", "previous", "meetings", "and", "teleconferences", "that", "its", "members", "wish", "to", "review", "the", "manuscript", "for", "all", "abstracts", "for", "future", "conferences", "The", "EC", "discussed", "the", "stage", "at", "which", "each", "manuscript", "would", "be", "ready", "for", "EC", "review.", "It", "was", "confirmed", "that", "the", "EC", "require", "a", "draft", "of", "the", "manuscript", "that", "demonstrates", "the", "aims", "of", "the", "paper,", "how", "to", "interpret", "the", "data", "and", "how", "the", "manuscript", "will", "be", "discussed", "in", "the", "context", "of", "other", "data.", "This", "is", "more", "than", "simply", "an", "outline", "of", "what", "would", "be", "included", "in", "the", "manuscript", "together", "with", "supporting", "data.", "Figures", "and", "tables", "are", "required", "at", "this", "stage", "of", "review.", "The", "EC", "Lead", "will", "take", "responsibility", "for", "determining", "the", "stage", "at", "which", "the", "manuscript", "is", "ready", "for", "review.", "The", "EC", "is", "not", "interested", "in", "refining", "the", "wording", "of", "manuscripts,", "but", "all", "authors", "would", "need", "to", "agree", "on", "the", "solidity", "of", "the", "data", "and", "would", "need", "to", "agree", "to", "presentation", "of", "an", "abstract,", "in", "order", "for", "the", "EC", "to", "carry", "out", "a", "review.", "JD", "advised", "the", "EC", "that", "previous", "indications", "to", "the", "Committee", "that", "the", "EAC", "reviewed", "all", "cases", "of", "heart", "failure", "resulting", "in", "death,", "as", "discussed", "during", "the", "last", "meeting/call,", "is", "incorrect", "The", "Endpoint", "Adjudication", "Committee", "reviewed", "all", "fatal", "events,", "however,", "there", "was", "no", "classification", "regarding", "death", "due", "to", "heart", "ailure", "by", "the", "Committee/Panellists.", "This", "determination", "was", "made", "by", "the", "Investigator.", "Professor", "Ryden", "Karolinska", "Institute,", "Stockholm)", "will", "lead", "an", "independent", "commission", "into", "heart", "failure", "and", "the", "results", "of", "these", "findings", "are", "awaite", "1.1", "Revised", "membership", "of", "the", "Executive", "Committee", "Following", "EE's", "initial", "discussions", "with", "Professor", "Ferrannini", "and", "Professor", "Wilcox,", "IM", "reported", "that", "he", "had", "written", "to", "them,", "outlining", "details", "of", "the", "contract", "held", "with", "EC", "members,", "together", "with", "the", "proposed", "honorarium.", "The", "actual", "contracts", "are", "currently", "held", "up", "within", "Takeda", "but", "will", "be", "sent", "out", "within", "one", "week", "Action:", "IM", "to", "forward", "EC", "contracts", "to", "EC", "members.", "Takeda", "\"PROspective", "PioglitAzone", "Clinical", "Trial", "In", "MacroVascular", "Events", "Lilly", "Page", "1", "of", "6", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-MOULEI-00026121", "Source:", "https://www.indup6056-oooents.ucsf.edu/docs/Itjf0226" ]
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{ "answers": [ { "answer_end": [ 3, 5 ], "answer_start": [ 2, 2 ], "text": [ "ACTOS PRODUCTS", "ACTOS PRODUCTS LIABILITY CLAIMS" ] }, { "answer_end": [ 407 ], "answer_start": [ 406 ], "text": [ "1/11/2007" ] }, { "answer_end": [ 33 ], "answer_start": [ 33 ], "text": [ "52" ] } ], "question": [ "Which product's liability claims are described here?", "What is the date mentioned in this document at the bottom?", "What is the exhibit number?" ], "question_id": [ 1253, 1254, 1256 ] }
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{ "answers": [ { "answer_end": [ 67, 67 ], "answer_start": [ 65, 65 ], "text": [ "Document Storage Period", "document storage period" ] }, { "answer_end": [ 69, 69 ], "answer_start": [ 69, 68 ], "text": [ "7", "Article 7" ] }, { "answer_end": [ 168, 168 ], "answer_start": [ 163, 163 ], "text": [ "To be stored for ten years", "to be stored for ten years" ] } ], "question": [ "what is the title of chapter 3?", "what is the \"document storage period \" article number?", "mention the second point listed under the article 7(document storage period)?" ], "question_id": [ 1265, 1269, 1271 ] }
[ "(2)", "The", "person", "in", "charge", "of", "storage", "shall", "properly", "store,", "and", "dispose", "of,", "any", "stored", "documents", "assigned,", "and", "properly", "store", "any", "records", "relevant", "to", "those", "storage", "and", "disposal.", "(3)", "In", "case", "the", "document", "storage", "functions", "are", "reorganized", "or", "abolished", "due", "to", "organizational", "changes,", "etc.,", "the", "core", "organizations", "taking", "over", "the", "document-related", "operations", "shall", "continue", "to", "store", "the", "documents", "and", "retain", "the", "disposal", "records.", "Chapter", "3", "Document", "Storage", "Period", "Article", "7", "(Document", "Storage", "Period)", "The", "responsible", "person", "in", "charge", "of", "storage", "shall", "establish", "storage", "periods", "for", "different", "types", "of", "assigned", "documents,", "by", "checking", "opinions", "of", "the", "relevant", "internal", "functions,", "if", "necessary,", "and", "distinguish", "and", "designate", "the", "periods,", "in", "principle,", "as", "indicated", "below.", "However,", "if", "the", "storage", "periods", "are", "specified", "by", "laws,", "regulations", "or", "Company", "Regulations,", "they", "shall", "be", "established", "in", "compliance", "with", "those", "laws,", "regulations", "and", "Company", "Regulations.", "The", "starting", "point", "for", "determining", "a", "storage", "period", "shall", "be,", "in", "principle,", "the", "date", "on", "which", "the", "document", "is", "created.", "1.", "To", "be", "stored", "permanently", "2.", "To", "be", "stored", "for", "ten", "years", "3.", "To", "be", "stored", "for", "seven", "years", "4.", "To", "be", "stored", "for", "five", "years", "5.", "To", "be", "stored", "for", "three", "years", "6.", "To", "be", "stored", "for", "one", "year", "7.", "To", "be", "stored", "for", "less", "than", "one", "year", "(to", "be", "disposed", "of", "promptly", "after", "use)", "(2)", "If", "a", "document", "turns", "out", "not", "to", "be", "categorized", "into", "any", "document", "types", "designated", "for", "specified", "storage", "periods,", "the", "responsible", "person", "in", "charge", "of", "storage", "shall", "establish", "a", "storage", "period", "for", "the", "new", "document", "type,", "as", "stipulated", "in", "the", "preceding", "paragraph.", "(3)", "Concerning", "the", "provisions", "set", "forth", "in", "Paragraph", "I", "above,", "the", "following", "documents", "shall", "be", "stored", "permanently.", "1.", "Articles", "of", "Incorporation", "and", "Company", "Regulations", "2.", "Important", "documents", "concerning", "the", "General", "Meetings", "of", "Shareholders,", "the", "Board", "of", "Directors,", "the", "Management", "and", "Operations", "Committee,", "and", "other", "important", "conferences.", "3.", "Important", "documents", "concerning", "mid/long-range", "management", "policies", "and", "plans", "4.", "Important", "documents", "concerning", "the", "Company's", "rights", "and", "duties,", "including", "important", "contracts,", "lawsuits,", "registrations,", "etc.", "Important", "documents", "concerning", "budgets,", "account", "settlements,", "and", "other", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAKJ-TPC-00000254", "Source:", "https://www.indup2378", "0boats.ucsf.edu/docs/jpjf0226" ]
null
null
3
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null
jpjf0226_3.png
1,700
2,236
{ "answers": [ { "answer_end": [ 73, 73, 73 ], "answer_start": [ 70, 70, 70 ], "text": [ "(PRINCIPLES OF CREATING DOCUMENTS)", "principles of creating documents", "PRINCIPLES OF CREATING DOCUMENTS" ] }, { "answer_end": [ 102, 102 ], "answer_start": [ 100, 100 ], "text": [ "DOCUMENT STORAGE FUNCTIONS", "document storage functions" ] }, { "answer_end": [ 109, 109 ], "answer_start": [ 105, 105 ], "text": [ "(principles concerning document storage functions)", "principles concerning document storage functions" ] }, { "answer_end": [ 295, 295, 295 ], "answer_start": [ 282, 282, 282 ], "text": [ "DUTIES OF RESPONSIBLE PERSON IN CHARGE OF STORAGE AND PERSON IN CHARGE OF STORAGE", "duties of responsible person in charge of storage and person in charge of storage", "(DUTIES OF RESPONSIBLE PERSON IN CHARGE OF STORAGE AND PERSON IN CHARGE OF STORAGE)" ] } ], "question": [ "what is article 4?", "what is the title of chapter 2?", "What does article 5 in this document describes?", "what is article 6?" ], "question_id": [ 1272, 1274, 1277, 1278 ] }
[ "3)", "Other", "places", "designated", "by", "the", "relevant", "core", "organizations", ".", "\"Responsible", "person", "in", "charge", "of", "storage\"", "shall", "mean", "the", "responsible", "person", "in", "charge", "of", "a", "core", "organization.", "5.", "\"Person", "in", "charge", "of", "storage\"", "shall", "mean", "a", "person", "in", "the", "\"Line", "Position\"", "or", "the", "\"Quasi-Line", "Position\",", "as", "stipulated", "from", "Article", "41", "1", "through", "Article", "422", "of", "the", "Business", "Organization", "Rule,", "appointed", "by", "the", "responsible", "person", "in", "charge", "of", "storage.", "Article", "4", "(Principles", "of", "Creating", "Documents)", "Clerical", "operations", "shall", "be", "performed,", "in", "principle,", "based", "on", "documents.", "However,", "efforts", "shall", "be", "made", "to", "minimize", "the", "amount", "of", "documents", "to", "be", "created.", "Chapter", "2", "Document", "Storage", "Functions", "Article", "5", "(Principles", "concerning", "Document", "Storage", "Functions", ")", "In", "principle,", "for", "documents", "created", "internally,", "the", "document", "storage", "functions", "shall", "be", "the", "core", "organizations", "in", "charge", "of", "the", "creation;", "and", "for", "those", "created", "externally,", "the", "core", "organizations", "that", "have", "received", "the", "documents", "shall", "be", "the", "document", "storage", "functions.", "However,", "in", "the", "case", "of", "documents", "created", "internally,", "if", "the", "receiving", "core", "organizations", "are", "designated", "to", "store", "the", "documents,", "as", "stipulated", "by", "laws,", "regulations", "or", "Company", "Regulations,", "the", "receiving", "core", "organizations", "shall", "be", "the", "document", "storage", "function.", "(2)", "Notwithstanding", "the", "preceding", "paragraph,", "materials", "for", "the", "agenda", "of", "the", "Board", "of", "Directors", "and", "Management", "and", "Operations", "Committee,", "and", "other", "conferences,", "shall", "be", "stored", "at", "the", "core", "organizations", "functioning", "as", "the", "secretariats", "for", "the", "conferences.", "(3)", "Documents", "shall", "be,", "in", "principle,", "centrally", "stored", "at", "the", "document", "storage", "functions,", "In", "other", "words,", "functions", "other", "than", "the", "document", "storage", "functions", "shall", "not", "store", "the", "relevant", "documents,", "and", "shall", "thus", "dispose", "of", "any", "documents", "promptly", "after", "they", "are", "no", "longer", "necessary", "(delete", "any", "electromagnetic", "records;", "the", "same", "shall", "apply", "to", "the", "rest", "of", "this", "Policy)", "Article", "6", "(Duties", "of", "Responsible", "Person", "in", "Charge", "of", "Storage", "and", "Person", "in", "Charge", "of", "Storage", "The", "responsible", "person", "in", "charge", "of", "storage", "shall", "have", "the", "person", "in", "charge", "of", "storage", "properly", "store,", "and", "dispose", "of,", "any", "stored", "documents", "in", "the", "relevant", "core", "organization,", "and", "ensure", "that", "any", "relevant", "subordinates", "observe", "this", "Policy", "and", "the", "Function", "Standards", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAKJ-TPC-00000253", "Source:", "https://www.indup237800002ts.ucsf.edu/docs/jpjf0226" ]
null
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2
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jpjf0226_2.png
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{ "answers": [ { "answer_end": [ 3, 3 ], "answer_start": [ 0, 0 ], "text": [ "Rationale for 3 segments", "Rationale for 3 Segments" ] }, { "answer_end": [ 16 ], "answer_start": [ 13 ], "text": [ "Summary of Segment Attractiveness" ] }, { "answer_end": [ 23, 23, 23 ], "answer_start": [ 17, 17, 19 ], "text": [ "based on current situation & future trends", "Based on current situation & future trends.", "current situation & future trends" ] }, { "answer_end": [ 30 ], "answer_start": [ 24 ], "text": [ "Treatment Machines, Life Negotiators, Struggle for Control" ] }, { "answer_end": [ 40, 40 ], "answer_start": [ 35, 35 ], "text": [ "All 3 segments have consistent needs", "All 3 Segments Have Consistent Needs." ] } ], "question": [ "What is the heading of this document?", "What is the graphical representation about?", "On what basis, the Summary of Segment Attractiveness is carried out?", "What are the three segments indicated in the graph?", "What is the conclusion obtained from the graph?" ], "question_id": [ 1264, 1266, 1267, 1268, 1270 ] }
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null
null
2
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{ "answers": [ { "answer_end": [ 0, 2 ], "answer_start": [ 0, 0 ], "text": [ "ACTOS", "ACTOS PEDIATRIC PROGRAM" ] }, { "answer_end": [ 5 ], "answer_start": [ 3 ], "text": [ "5 October 2006" ] } ], "question": [ "what is the name of pediatric program?", "What is the date mentioned in this page?" ], "question_id": [ 1280, 1282 ] }
[ "ACTOS", "Pediatric", "Program", "5", "October", "2006", "TAK-TROOSA-00427563", "Source:", "https://www.industrydocu?<", "<-09001", "cuments.ucsf.edu/docs/jfkf0226" ]
null
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1
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{ "answers": [ { "answer_end": [ 1, 1 ], "answer_start": [ 0, 0 ], "text": [ "TARC STRATEGY", "TARC Strategy" ] } ], "question": [ "What is the title of this document?" ], "question_id": [ 50981 ] }
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6
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{ "answers": [ { "answer_end": [ 2, 2 ], "answer_start": [ 0, 0 ], "text": [ "ACTOS PLAN OVERVIEW", "Actos plan overview" ] }, { "answer_end": [ 41, 41 ], "answer_start": [ 41, 41 ], "text": [ "TZD'S", "TZD's" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "ACTOS" ] } ], "question": [ "What is the title of this page?", "which are prescibed eariler in the treatment of type 2 diabetes under the title of \"critical success factors\"?", "which has a superior lipid profile(v. avandia and others) under the title of \"strength/opportunities?" ], "question_id": [ 1294, 1295, 1304 ] }
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null
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{ "answers": [ { "answer_end": [ 47 ], "answer_start": [ 43 ], "text": [ "August 12 - 13, 2002" ] }, { "answer_end": [ 48 ], "answer_start": [ 48 ], "text": [ "3" ] }, { "answer_end": [ 4 ], "answer_start": [ 0 ], "text": [ "Basic Strategy for FDA Response(1)" ] }, { "answer_end": [ 7, 7 ], "answer_start": [ 6, 5 ], "text": [ "Label change", "1. Label change" ] } ], "question": [ "What is the date mentioned in the document?", "What is the page number given at the footer?", "What is the heading of the document?", "What is the first sub-heading in the document?" ], "question_id": [ 50972, 50973, 50974, 50978 ] }
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null
null
3
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{ "answers": [ { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "Agenda" ] }, { "answer_end": [ 5 ], "answer_start": [ 1 ], "text": [ "OAD Market / IR Review" ] }, { "answer_end": [ 11 ], "answer_start": [ 10 ], "text": [ "Q&A Discussion" ] } ], "question": [ "What is the title of this document?", "What is listed first on the agenda?", "What is listed last on the agenda?" ], "question_id": [ 50975, 50976, 50977 ] }
[ "Agenda", "OAD", "Market", "/", "IR", "Review", "Evolving", "Medical", "Data", "Overview", "Q&A", "Discussion", "<AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001896", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induptosag-0ooo2ts.ucsf.edu/docs/ynjf0226" ]
null
null
2
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{ "answers": [ { "answer_end": [ 2 ], "answer_start": [ 0 ], "text": [ "Consequences of IR" ] } ], "question": [ "What is the title of this document?" ], "question_id": [ 1287 ] }
[ "Consequences", "of", "IR", "Damage", "to", "Eyes", "Damage", "to", "Kidneys", "HDL-C", "LDL-C", "Damage", "to", "Nerves", "Increased", "CV", "Risk", "Increased", "CV", "Risk", "Hyperglycemia", "Dyslipidemia", "Insulin", "Resistance", "Central", "Obesity", "Hypertension", "Increased", "CV", "Risk", "Increased", "CV", "Risk", "<AUTO>", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-HOVENR-00001900", "Produced", "in", "MDL", "on", "02/27/13", "Source:", "https://www.induposciscoooacts.ucsf.edu/docs/ynjf0226" ]
null
null
6
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{ "answers": [ { "answer_end": [ 1, 0 ], "answer_start": [ 0, 0 ], "text": [ "Clinical Study", "clinical" ] }, { "answer_end": [ 3 ], "answer_start": [ 3 ], "text": [ "01-06-TL-OPI-527" ] }, { "answer_end": [ 10, 10 ], "answer_start": [ 8, 8 ], "text": [ "4 OCTOBER 2006", "4 october 2006" ] } ], "question": [ "Which study's synopsis is this?", "what is the code mentioned under the title of clinical study synopsis?", "When was expert advisory meeting ?" ], "question_id": [ 1309, 1310, 1311 ] }
[ "Clinical", "Study", "Synopsis", "01-06-TL-OPI-527", "o", "Expert", "advisory", "meeting", "4", "October", "2006", "o", "Draft", "synopsis", "available", "for", "team", "review", "on", "Monday,", "9", "October", "2006", "o", "Team", "proposing", "to", "review", "synopsis", "in", "TARC", "instead", "of", "SRC", "o", "Need", "detailed", "timelines", "of", "full", "study", "by", "20", "October", "2006", "Need", "budget,", "delineating", "what", "may", "be", "spent", "in", "FY06,", "by", "20", "October", "2006", "TAK-TROOSA-00427563", "Source:", "https://www.industrydocuments.ucsf.edu/docs/jfkf0226" ]
null
null
4
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{ "answers": [ { "answer_end": [ 14 ], "answer_start": [ 12 ], "text": [ "Critical Success Factors" ] }, { "answer_end": [ 94, 94 ], "answer_start": [ 91, 91 ], "text": [ "ACTOS EQUALS BEST ORAL.", "Actos equals best oral." ] }, { "answer_end": [ 154, 154 ], "answer_start": [ 151, 151 ], "text": [ "COMPETITIVE SHARE OF VOICE", "Competitive Share of Voice" ] } ], "question": [ "What is the first column under Key Player Segments?", "What is the KP Objective of 'Prescriber' for the success factor 'Differentiate Actos vs. other oral diabetes agents'?", "What is the third 'Critical Success Factors' mentioned in the document?" ], "question_id": [ 50964, 50969, 50971 ] }
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null
null
10
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null
null
xqjf0226_10.png
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{ "answers": [ { "answer_end": [ 5, 5 ], "answer_start": [ 3, 3 ], "text": [ "CRITICAL SUCCESS FACTORS", "Critical Success Factors" ] } ], "question": [ "What is the title of this document?" ], "question_id": [ 1283 ] }
[ "Alex", "OD", "PoRET", "Critical", "Success", "Factors", "actos", "pioglitazone", "HCI", "For", "performance", "that", "benefits", "the", "body", "1.", "Condition", "the", "Market", "on", "IR", "and", "its", "link", "to", "CV", "risk", "including", "lipid", "abnormalities", "2.", "Differentiate", "ACTOS", "vs.", "other", "OAD's", "3.", "Maintain", "a", "Competitive", "Share", "of", "Voice", "Source:", "https://www.induptasdg", "ooooats.ucsf.edu/docs/xqjf0226" ]
null
null
8
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null
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{ "answers": [ { "answer_end": [ 45, 45 ], "answer_start": [ 40, 40 ], "text": [ "OBSERVED DURING PRECLINICAL STUDIES IN RATS", "observed during preclinical studies in rats" ] }, { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "1.7%", "1.7" ] }, { "answer_end": [ 34, 34 ], "answer_start": [ 34, 34 ], "text": [ "0.20%", "0.20" ] }, { "answer_end": [ 98 ], "answer_start": [ 98 ], "text": [ "10" ] }, { "answer_end": [ 0 ], "answer_start": [ 0 ], "text": [ "5" ] } ], "question": [ "what is the first point given in table for bladder cancer alongside of clinical findings ?", "how much percent of drug quantity present in rezulin under the title of 'clinical findings'?", "how much percent of placebo present in avandia alongside of the clinical findings?", "what is the total number of all claims under the title of \"summary of litigation risk in the ous territories\"?", "what is the total number of drug claims under the title of \"summary of litigation risk in the ous territories\"?" ], "question_id": [ 1329, 1337, 1340, 1343, 1388 ] }
[ "Most", "Significant", "Adverse", "Events", "Risks", "for", "Pioglitazone", "Risk", "Onset", "Reversibility", "Clinical", "Findings", "Occurrence", "of", "ALT", "Elevation", "Within", "2", "months", "Only", "through", "Drug", "Placebo", "Liver", "Failure", "Transplant", "Rezulln", "1.1", "70", "0.120.", "ACTOS", "0.26%", "0.25%", "Avandia", "0.20%", "0.20%", "Cardiac", "Hypertrophy", "Unknown", "Unknown", "Observed", "during", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Unknown", "Unknown", "Observed", "during", "Bladder", "Cancer", "Preclinical", "Studies", "in", "Rats", ".", "No", "cases", "in", "Humans", "Edema", "Within", "Yes", "Occurrence", "of", "Edema", "12", "months", "Drug", "Placebo", "ACTOS", "15.3%", "7.0%", "Summary", "of", "Litigation", "Risk", "in", "the", "OUS", "Territories", "Out", "of", "10,359", "claims", "on", "the", "Litigation", "Support", "System", "database,", "only", "10", "claims", "have", "arose", "from", "the", "Territory", "in", "this", "Agreement", "Country", "All", "Claims", "Drug", "Claims", "Australia", "Saudi", "Arabia", "South", "Africa", "Spain", "Sweden", "Total", "U", "-", "OO", "-", "W", "4", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002626", "Source:", "https://www.indup5350", "0oo04ts.ucsf.edu/docs/trjf0226" ]
null
null
4
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null
null
trjf0226_4.png
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{ "answers": [ { "answer_end": [ 15, 15 ], "answer_start": [ 11, 11 ], "text": [ "August 12 - 13,2002", "August 12-13, 2002" ] }, { "answer_end": [ 16 ], "answer_start": [ 16 ], "text": [ "7" ] }, { "answer_end": [ 1 ], "answer_start": [ 0 ], "text": [ "Communication Route" ] } ], "question": [ "What is the date rang mentioned in this document at the bottom?", "What is the page no mentioned in this document?", "What is the title of this document?" ], "question_id": [ 50983, 50985, 50986 ] }
[ "Communication", "Route", "CEO", "H", "Mr.", "Saito", "TPNA", "TCI", "Labs.", "Lilly", "EuR&D", "August", "12", "-", "13,", "2002", "7", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019741", "Produced", "in", "MDL", "on", "09/14/12", "Source:", "https://www.indupo452-00607s.ucsf.edu/docs/ymjf0226" ]
null
null
7
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null
ymjf0226_7.png
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{ "answers": [ { "answer_end": [ 8 ], "answer_start": [ 6 ], "text": [ "Bladder toxicity monitoring" ] }, { "answer_end": [ 24 ], "answer_start": [ 20 ], "text": [ "To investigate appropriate monitoring methods" ] } ], "question": [ "What is the second strategy for FDA response?", "What is the second purpose of 'bladder toxicity monitoring'?" ], "question_id": [ 50979, 50984 ] }
[ "Basic", "Strategy", "for", "FDA", "Response(2)", "2.", "Bladder", "toxicity", "monitoring", "-", "To", "find", "a", "good", "rationale", "for", "not", "conducting", "monitoring", "-", "To", "investigate", "appropriate", "monitoring", "methods", ".", "There", "is", "an", "option", "to", "accept", "the", "FDA", "suggestion", "if", "this", "satisfies", "FDA", "and", "allows", "us", "to", "keep", "the", "current", "label", "wording", "August", "12", "-", "13,", "2002", "4", "Confidential", "-", "Subject", "to", "Protective", "Order", "TAK-THOMCL-00019738", "Produced", "in", "MDL", "or", "Source:", "https://www.indup0452-00004s.ucsf.edu/docs/ymjf0226" ]
null
null
4
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{ "answers": [ { "answer_end": [ 81 ], "answer_start": [ 74 ], "text": [ "$0.17 / 30 mg or Takeda's cost from site of lowest cost" ] }, { "answer_end": [ 102, 104 ], "answer_start": [ 102, 102 ], "text": [ "50%", "50% royalty adjustment" ] }, { "answer_end": [ 58, 58, 55 ], "answer_start": [ 53, 53, 53 ], "text": [ "Split of 70/30 (Lilly in Exclusive)", "split of 70/30 (Lilly in exclusive)", "Split of 70/30" ] }, { "answer_end": [ 61 ], "answer_start": [ 59 ], "text": [ "50/50 in Semi-exclusive" ] } ], "question": [ "What is the floor supply price?", "What is the royalty adjustment if generic enters the market ?", "what is the promotional trails data usage for( Lilly in exclusive) ?", "What is the promotional trials data usage for (semi exclusive)?" ], "question_id": [ 1320, 1321, 1322, 1324 ] }
[ "Overview", "of", "Major", "Contract", "Terms", "Promotional", "Samples", "At", "Cost", "New", "Indications/Line", "Extension", "Takeda", "must", "offer", "to", "Lilly", "If", "Lilly", "agrees,", "then", "cost", "sharing", "based", "on", "expected", "benefit\"", "If", "Lilly", "disagrees,", "Takeda", "/", "Lilly", "agree", "on", "any", "damages", "due", "Lilly", "Promotional", "Trials", "Data", "Usage", "Both", "parties", "can", "gain", "access", "to", "each", "others", "trial", "data", "Split", "of", "70/30", "(Lilly", "in", "Exclusive)", "50/50", "in", "Semi-exclusive", "Sub-license", "Right", "to", "sub-license", "with", "Takeda's", "consent", "Floor", "Supply", "Price", "50.17", "/", "30mg", "or", "Takeda's", "Cost", "from", "site", "of", "lowest", "cost", "Overview", "of", "Major", "Contract", "Terms", "Termination", "Right", "to", "terminate", "in", "specific", "markets", "if", "significant", "events", "occur", "Generic", "Entry", "Adjustment", "50%", "royalty", "adjustment", "if", "generic", "enters", "the", "market", "and", "causes", "sales", "decline", "of", "25%", "Intellectual", "Property", "Fakeda", "owns", "all", "5", "Confidential", "-", "Subject", "to", "Protective", "Order", "LLY-RANSOM-00002627", "Source:", "https://www.indup5350-00005", "ts.ucsf.edu/docs/trjf0226" ]
null
null
5
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{ "answers": [ { "answer_end": [ 18, 19 ], "answer_start": [ 18, 18 ], "text": [ "20", "20 countries" ] }, { "answer_end": [ 48, 48 ], "answer_start": [ 46, 46 ], "text": [ "30% SUPPLY PRICE", "30% supply price" ] }, { "answer_end": [ 12, 12, 11 ], "answer_start": [ 9, 11, 11 ], "text": [ "in approximately 60 countries", "60 COUNTRIES", "60" ] } ], "question": [ "Semi exclusive rights in how many countries?", "What percent is the Supply Price / Royalty Rate?", "In how many countires, license to Exclusive rights are provided?" ], "question_id": [ 1273, 1276, 1279 ] }
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null
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{ "answers": [ { "answer_end": [ 0, 0 ], "answer_start": [ 0, 0 ], "text": [ "CSF'S AND MARKETING OBJECTIVES", "CSF's and Marketing Objectives" ] } ], "question": [ "What is the title mentioned in this document?" ], "question_id": [ 1323 ] }
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null
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