STUDYID,USUBJID,SUBJID,SITEID,TRTP,TRTPN,TRTA,TRTAN,RANDFL,SAFFL,MITTFL,PPROTFL,TRTSDT,TRTEDT,AESEQ,AESEV,AESEVN,AEREL,AREL,AEACN,AACN,AESER,ASER,AECAT,AESTDTC,AETERM,AEDECOD,AEPTCD,AESOC,AESOCCD,AEBODSYS,AEBDSYCD,AEHLT,AEHLTCD,AEHLGT,AEHLGTCD,AESTDY,ASTDT,ASTDY,ASTDTF,AEENDTC,AEENDY,AENDT,AENDY,AENDTF,ADURN,AOCCFL,AOCCSFL,AOCCPFL,AOCCIFL,AOCCSIFL,AOCCPIFL,AOCCRLFL,AOCCDSFL,AOCCSRFL,AOCCSVFL
BBC,BBC-10-042,042,10,ARM C,3,ARM C,3,Y,Y,Y,Y,10JAN2007,13APR2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-05,FLU,INFLUENZA LIKE ILLNESS,10022004,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,General signs and symptoms NEC,10018072,Fatal outcomes,10053172,27,05FEB2007,27,,2007-02-08,30,08FEB2007,30,,4,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-10-043,043,10,ARM A,1,ARM A,1,Y,Y,Y,Y,09FEB2007,03MAY2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-22,LIGHTHEADNESS,DIZZINESS,10013573,Nervous system disorders,10029205,Nervous system disorders,10029205,Cardiac signs and symptoms NEC,10007609,Central nervous system infections and inflammations,10007951,14,22FEB2007,14,,2007-02-22,14,22FEB2007,14,,1,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-10-043,043,10,ARM A,1,ARM A,1,Y,Y,Y,Y,09FEB2007,03MAY2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-03-15,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,35,15MAR2007,35,,2007-03-15,35,15MAR2007,35,,1,,,Y,,,Y,,,,
BBC,BBC-10-043,043,10,ARM A,1,ARM A,1,Y,Y,Y,Y,09FEB2007,03MAY2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-04-10,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,61,10APR2007,61,,2007-04-10,61,10APR2007,61,,1,,,,,,,,,,
BBC,BBC-10-043,043,10,ARM A,1,ARM A,1,Y,Y,Y,Y,09FEB2007,03MAY2007,4,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-04-30,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,81,30APR2007,81,,2007-04-30,81,30APR2007,81,,1,,,,,,,,,,
BBC,BBC-10-043,043,10,ARM A,1,ARM A,1,Y,Y,Y,Y,09FEB2007,03MAY2007,5,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-04-11,CRAMPS,HEAT CRAMPS,10019330,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,Heat injuries (excl thermal burns),10019338,Bone and joint injuries,10005942,62,11APR2007,62,,2007-04-12,63,12APR2007,63,,2,,Y,Y,,Y,Y,,,,
BBC,BBC-10-145,145,10,ARM A,1,ARM A,1,Y,Y,Y,N,08DEC2006,30MAR2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-20,HYPERTRIGLYCERIDEMIA,BLOOD TRIGLYCERIDES INCREASED,10005839,Investigations,10022891,Investigations,10022891,Triglyceride analyses,10044657,Cardiac and vascular investigations (excl enzyme tests),10007512,13,20DEC2006,13,,,,,,,,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-10-145,145,10,ARM A,1,ARM A,1,Y,Y,Y,N,08DEC2006,30MAR2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-03,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,58,03FEB2007,58,,2007-02-04,59,04FEB2007,59,,2,,Y,Y,,Y,Y,,,,
BBC,BBC-10-145,145,10,ARM A,1,ARM A,1,Y,Y,Y,N,08DEC2006,30MAR2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-10,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,65,10FEB2007,65,,2007-02-10,65,10FEB2007,65,,1,,,,,,,,,,
BBC,BBC-10-145,145,10,ARM A,1,ARM A,1,Y,Y,Y,N,08DEC2006,30MAR2007,4,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-03,STOMACH FLU / UPSET,STOMACH DISCOMFORT,10042101,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Gastrointestinal signs and symptoms NEC,10027678,Abdominal hernias and other abdominal wall conditions,10000073,58,03FEB2007,58,,2007-02-04,59,04FEB2007,59,,2,,Y,Y,,Y,Y,,,,
BBC,BBC-10-145,145,10,ARM A,1,ARM A,1,Y,Y,Y,N,08DEC2006,30MAR2007,5,MILD,1,NOT RELATED,NOT RELATED,NOT APPLICABLE,NOT APPLICABLE,N,N,GENERAL ADVERSE EVENT,2007-03-30,LOW TOTAL 25 - HYDROXY D,VITAMIN D DECREASED,10062189,Investigations,10022891,Investigations,10022891,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,113,30MAR2007,113,,,,,,,,,,Y,,,Y,,,,
BBC,BBC-10-148,148,10,ARM B,2,ARM B,2,Y,Y,Y,Y,12DEC2006,07MAR2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-03,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,23,03JAN2007,23,,2007-01-03,23,03JAN2007,23,,1,,,,,,,,,,
BBC,BBC-10-148,148,10,ARM B,2,ARM B,2,Y,Y,Y,Y,12DEC2006,07MAR2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-14,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,3,14DEC2006,3,,2006-12-14,3,14DEC2006,3,,1,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-10-148,148,10,ARM B,2,ARM B,2,Y,Y,Y,Y,12DEC2006,07MAR2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-18,SINUSITIS,SINUSITIS,10040753,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,38,18JAN2007,38,,2007-01-23,43,23JAN2007,43,,6,,Y,Y,,Y,Y,,,,
BBC,BBC-11-094,094,11,ARM A,1,ARM A,1,Y,Y,Y,Y,08NOV2006,06FEB2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-27,PAIN AT BIOPSY SITE,PROCEDURAL PAIN,10064882,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,Non-site specific procedural complications,10029559,Bone and joint injuries,10005942,20,27NOV2006,20,,2006-12-18,41,18DEC2006,41,,22,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-11-094,094,11,ARM A,1,ARM A,1,Y,Y,Y,Y,08NOV2006,06FEB2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-27,INFECTION AT BIOPSY SITE,WOUND INFECTION,10048038,Infections and infestations,10021881,Infections and infestations,10021881,Infections NEC,10021902,Ancillary infectious topics,10002252,20,27NOV2006,20,,2006-11-30,23,30NOV2006,23,,4,,Y,Y,,Y,Y,,,,
BBC,BBC-11-095,095,11,ARM C,3,ARM C,3,Y,Y,Y,Y,10NOV2006,31JAN2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-05,RT. THUMB NAIL INFECTION,NAIL INFECTION,10061304,Infections and infestations,10021881,Infections and infestations,10021881,Skin structures and soft tissue infections,10040786,Ancillary infectious topics,10002252,26,05DEC2006,26,,2007-02-16,99,16FEB2007,99,,74,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-11-096,096,11,ARM D,4,ARM D,4,Y,Y,Y,N,27NOV2006,05MAR2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE REDUCED,DOSE REDUCED,N,N,GENERAL ADVERSE EVENT,2006-02-21,TORE CALF MUSCLE,MUSCLE INJURY,10028314,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,"Muscle, tendon and ligament injuries",10028288,Bone and joint injuries,10005942,-279,21FEB2006,-279,,2007-04-19,144,19APR2007,144,,423,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-11-096,096,11,ARM D,4,ARM D,4,Y,Y,Y,N,27NOV2006,05MAR2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-23,CONGESTION,UPPER RESPIRATORY TRACT CONGESTION,10052252,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Upper respiratory tract signs and symptoms,10046313,Bronchial disorders (excl neoplasms),10006436,27,23DEC2006,27,,2006-12-26,30,26DEC2006,30,,4,,Y,Y,,Y,Y,,,,
BBC,BBC-11-097,097,11,ARM A,1,ARM A,1,Y,Y,Y,N,28NOV2006,20FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,NOT APPLICABLE,NOT APPLICABLE,N,N,GENERAL ADVERSE EVENT,2007-01-05,KNEE PAIN,PAIN IN EXTREMITY,10033425,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,39,05JAN2007,39,,2007-01-10,44,10JAN2007,44,,6,,Y,Y,,Y,Y,,,,
BBC,BBC-11-097,097,11,ARM A,1,ARM A,1,Y,Y,Y,N,28NOV2006,20FEB2007,2,MILD,1,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-29,COLD SYMPTOMS,RESPIRATORY TRACT INFECTION,10062352,Infections and infestations,10021881,Infections and infestations,10021881,Infections NEC,10021902,Ancillary infectious topics,10002252,2,29NOV2006,2,,2006-12-12,15,12DEC2006,15,,14,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-11-098,098,11,ARM C,3,ARM C,3,Y,Y,Y,Y,04DEC2006,26FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-18,UPPER RESPIRATORY INFECTION,UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,77,18FEB2007,77,,2007-02-26,85,26FEB2007,85,,9,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-12-058,058,12,ARM A,1,ARM A,1,Y,Y,Y,Y,15NOV2006,06FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,NOT APPLICABLE,NOT APPLICABLE,N,N,GENERAL ADVERSE EVENT,2007-02-09,UPPER LEFT LATERAL BACK PUSTULE WITH PAIN,RASH PUSTULAR,10037888,Infections and infestations,10021881,Infections and infestations,10021881,Pustular conditions,10037573,Ancillary infectious topics,10002252,87,09FEB2007,87,,2007-03-02,108,02MAR2007,108,,22,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-12-059,059,12,ARM D,4,ARM D,4,Y,Y,Y,N,17NOV2006,07FEB2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-29,PRURITIS (INCREASED),PRURITUS,10037087,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Pruritus NEC,10049293,Angioedema and urticaria,10002426,43,29DEC2006,43,,2007-01-12,57,12JAN2007,57,,15,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-12-060,060,12,ARM C,3,ARM C,3,Y,Y,Y,Y,06DEC2006,27FEB2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02,BRONCHITIS,BRONCHITIS,10006451,Infections and infestations,10021881,Infections and infestations,10021881,Lower respiratory tract infections NEC,10024971,Ancillary infectious topics,10002252,,01FEB2007,58,D,2007-02,,01FEB2007,58,D,1,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-12-061,061,12,ARM B,2,ARM B,2,Y,Y,Y,N,04JAN2007,27MAR2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-16,ANGULAR CHEILITIS,CHEILITIS,10008417,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Dermal and epidermal conditions NEC,10012424,Abdominal hernias and other abdominal wall conditions,10000073,44,16FEB2007,44,,2007-05-01,118,01MAY2007,118,,75,,Y,Y,,Y,Y,,,,
BBC,BBC-12-061,061,12,ARM B,2,ARM B,2,Y,Y,Y,N,04JAN2007,27MAR2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-31,LAPROSCOPIC CHOLECYSTECTOMY,CHOLECYSTECTOMY,10008611,Surgical and medical procedures,10042613,Surgical and medical procedures,10042613,Biliary tract and gallbladder therapeutic procedures,10004675,Vascular therapeutic procedures,10003184,28,31JAN2007,28,,2007-01-31,28,31JAN2007,28,,1,,Y,Y,,Y,Y,,,,
BBC,BBC-12-061,061,12,ARM B,2,ARM B,2,Y,Y,Y,N,04JAN2007,27MAR2007,3,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-15,GALLBLADDER SPASMS,GALLBLADDER DISORDER,10017626,Hepatobiliary disorders,10019805,Hepatobiliary disorders,10019805,Gallbladder disorders NEC,10017629,Bile duct disorders,10004606,-20,15DEC2006,-20,,2007-01-15,12,15JAN2007,12,,32,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-12-063,063,12,ARM C,3,ARM C,3,Y,Y,Y,Y,23JAN2007,16APR2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-31,BRONCHITIS,BRONCHITIS,10006451,Infections and infestations,10021881,Infections and infestations,10021881,Lower respiratory tract infections NEC,10024971,Ancillary infectious topics,10002252,-23,31DEC2006,-23,,2007-01-25,3,25JAN2007,3,,26,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-025,025,13,ARM A,1,ARM A,1,Y,Y,Y,N,24OCT2006,03JAN2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-04,SWELLING - LEFT KNEE,JOINT SWELLING,10023232,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,Joint related signs and symptoms,10023226,Bone disorders (excl congenital and fractures),10005959,73,04JAN2007,73,,2007-02-01,101,01FEB2007,101,,29,,,Y,,,Y,,,,
BBC,BBC-13-025,025,13,ARM A,1,ARM A,1,Y,Y,Y,N,24OCT2006,03JAN2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-03,MUSCLE SORENESS RELATED TO MOTORCYCLE ACCIDENT,MYALGIA,10028411,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,Muscle pains,10028323,Bone disorders (excl congenital and fractures),10005959,72,03JAN2007,72,,2007-01-27,96,27JAN2007,96,,25,,Y,Y,,Y,Y,,,,
BBC,BBC-13-025,025,13,ARM A,1,ARM A,1,Y,Y,Y,N,24OCT2006,03JAN2007,3,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-01,COLD,RHINITIS,10039083,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,70,01JAN2007,70,,2007-01-04,73,04JAN2007,73,,4,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-026,026,13,ARM B,2,ARM B,2,Y,Y,Y,Y,02NOV2006,24JAN2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-02,KERATOTIC LESION REMOVAL,SKIN LESION EXCISION,10062250,Surgical and medical procedures,10042613,Surgical and medical procedures,10042613,Skin lesion excisions,10040885,Vascular therapeutic procedures,10003184,1,02NOV2006,1,,2006-11-02,1,02NOV2006,1,,1,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-027,027,13,ARM C,3,ARM C,3,Y,Y,Y,N,02NOV2006,24JAN2007,1,MILD,1,PROBABLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-02,BURNING,BURNING SENSATION,10006784,Nervous system disorders,10029205,Nervous system disorders,10029205,Paraesthesias and dysaesthesias,10033788,Central nervous system infections and inflammations,10007951,1,02NOV2006,1,,2006-12-19,48,19DEC2006,48,,48,Y,Y,Y,,Y,Y,Y,,,
BBC,BBC-13-027,027,13,ARM C,3,ARM C,3,Y,Y,Y,N,02NOV2006,24JAN2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-22,MENSTRUAL CRAMPS,MENSTRUAL DISCOMFORT,10056344,Reproductive system and breast disorders,10038604,Reproductive system and breast disorders,10038604,Menstruation and uterine bleeding NEC,10027335,Breast disorders,10006232,21,22NOV2006,21,,2006-11-28,27,28NOV2006,27,,7,,Y,Y,,Y,Y,,,,
BBC,BBC-13-027,027,13,ARM C,3,ARM C,3,Y,Y,Y,N,02NOV2006,24JAN2007,3,MODERATE,2,PROBABLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-02,INCREASED ITCHING,PRURITUS,10037087,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Pruritus NEC,10049293,Angioedema and urticaria,10002426,1,02NOV2006,1,,2006-12-19,48,19DEC2006,48,,48,,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-028,028,13,ARM D,4,ARM D,4,Y,Y,Y,Y,07NOV2006,29JAN2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-31,COUGH,COUGH,10011224,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Coughing and associated symptoms,10011233,Bronchial disorders (excl neoplasms),10006436,55,31DEC2006,55,,2007-01-04,59,04JAN2007,59,,5,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-031,031,13,ARM A,1,ARM A,1,Y,Y,Y,Y,21NOV2006,12FEB2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-29,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,9,29NOV2006,9,,2006-11-29,9,29NOV2006,9,,1,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-031,031,13,ARM A,1,ARM A,1,Y,Y,Y,Y,21NOV2006,12FEB2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-29,COLD,UPPER RESPIRATORY FUNGAL INFECTION,10062219,Infections and infestations,10021881,Infections and infestations,10021881,Fungal infections NEC,10017536,Ancillary infectious topics,10002252,9,29NOV2006,9,,2006-12-03,13,03DEC2006,13,,5,,Y,Y,,Y,Y,,,,
BBC,BBC-13-141,141,13,ARM D,4,ARM D,4,Y,Y,N,N,21NOV2006,24NOV2006,1,SEVERE,3,PROBABLY RELATED,RELATED,DRUG WITHDRAWN,DRUG WITHDRAWN,N,N,GENERAL ADVERSE EVENT,2006-11-21,BURNING,BURNING SENSATION,10006784,Nervous system disorders,10029205,Nervous system disorders,10029205,Paraesthesias and dysaesthesias,10033788,Central nervous system infections and inflammations,10007951,1,21NOV2006,1,,2006-11-26,6,26NOV2006,6,,6,Y,Y,Y,Y,Y,Y,Y,Y,,Y
BBC,BBC-13-141,141,13,ARM D,4,ARM D,4,Y,Y,N,N,21NOV2006,24NOV2006,2,MODERATE,2,PROBABLY RELATED,RELATED,DRUG WITHDRAWN,DRUG WITHDRAWN,N,N,GENERAL ADVERSE EVENT,2006-11-21,INCREASED ITCHING,PRURITUS,10037087,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Pruritus NEC,10049293,Angioedema and urticaria,10002426,1,21NOV2006,1,,2006-11-26,6,26NOV2006,6,,6,,Y,Y,,Y,Y,,,,
BBC,BBC-13-141,141,13,ARM D,4,ARM D,4,Y,Y,N,N,21NOV2006,24NOV2006,3,MODERATE,2,PROBABLY RELATED,RELATED,DRUG WITHDRAWN,DRUG WITHDRAWN,N,N,GENERAL ADVERSE EVENT,2006-11-21,INCREASED DRYNESS,SKIN DISCOMFORT,10040830,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Dermal and epidermal conditions NEC,10012424,Angioedema and urticaria,10002426,1,21NOV2006,1,,2006-11-26,6,26NOV2006,6,,6,,,Y,,,Y,,,,
BBC,BBC-13-143,143,13,ARM B,2,ARM B,2,Y,Y,Y,Y,19DEC2006,13MAR2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-13,COUGH,COUGH,10011224,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Coughing and associated symptoms,10011233,Bronchial disorders (excl neoplasms),10006436,26,13JAN2007,26,,2007-01-15,28,15JAN2007,28,,3,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-13-143,143,13,ARM B,2,ARM B,2,Y,Y,Y,Y,19DEC2006,13MAR2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-29,KNEE PAIN,PAIN IN EXTREMITY,10033425,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,42,29JAN2007,42,,2007-03-15,87,15MAR2007,87,,46,,Y,Y,,Y,Y,,,,
BBC,BBC-14-083,083,14,ARM C,3,ARM C,3,Y,Y,Y,N,14NOV2006,14FEB2007,1,MODERATE,2,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-11-16,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,3,16NOV2006,3,,2006-11-16,3,16NOV2006,3,,1,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-14-083,083,14,ARM C,3,ARM C,3,Y,Y,Y,N,14NOV2006,14FEB2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-30,UPPER RESPIRATORY INFECTION,UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,47,30DEC2006,47,,2007-01-04,52,04JAN2007,52,,6,,Y,Y,,Y,Y,,,,
BBC,BBC-14-084,084,14,ARM A,1,ARM A,1,Y,Y,Y,Y,14NOV2006,06FEB2007,1,MILD,1,POSSIBLY RELATED,RELATED,DOSE REDUCED,DOSE REDUCED,N,N,GENERAL ADVERSE EVENT,2006-12-23,DIARRHEA,DIARRHOEA,10012735,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Diarrhoea (excl infective),10012736,Abdominal hernias and other abdominal wall conditions,10000073,40,23DEC2006,40,,2006-12-24,41,24DEC2006,41,,2,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-14-084,084,14,ARM A,1,ARM A,1,Y,Y,Y,Y,14NOV2006,06FEB2007,2,MILD,1,POSSIBLY RELATED,RELATED,DOSE REDUCED,DOSE REDUCED,N,N,GENERAL ADVERSE EVENT,2006-12-23,NASAL CONGESTION,NASAL CONGESTION,10028735,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Nasal congestion and inflammations,10028736,Bronchial disorders (excl neoplasms),10006436,40,23DEC2006,40,,2006-12-24,41,24DEC2006,41,,2,,Y,Y,,Y,Y,,,,
BBC,BBC-14-087,087,14,ARM D,4,ARM D,4,Y,Y,Y,Y,16NOV2006,07FEB2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-13,ACUTE SINUS INFECTION,SINUSITIS,10040753,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,28,13DEC2006,28,,2006-12-21,36,21DEC2006,36,,9,,,Y,,,Y,,,,
BBC,BBC-14-087,087,14,ARM D,4,ARM D,4,Y,Y,Y,Y,16NOV2006,07FEB2007,2,MODERATE,2,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-02,TINEA PEDIS,TINEA PEDIS,10043873,Infections and infestations,10021881,Infections and infestations,10021881,Skin and subcutaneous tissue fungal infections,10040791,Ancillary infectious topics,10002252,17,02DEC2006,17,,2007-01-01,47,01JAN2007,47,,31,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-14-088,088,14,ARM B,2,ARM B,2,Y,Y,Y,Y,20NOV2006,12FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-07,FALL (X2) SECONDARY TO SLIPPING,FALL,10016173,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,Non-site specific injuries NEC,10029511,Bone and joint injuries,10005942,18,07DEC2006,18,,2006-12-07,18,07DEC2006,18,,1,,Y,Y,,Y,Y,,,,
BBC,BBC-14-088,088,14,ARM B,2,ARM B,2,Y,Y,Y,Y,20NOV2006,12FEB2007,2,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-10-31,URINARY TRACT INFECTION,URINARY TRACT INFECTION,10046571,Infections and infestations,10021881,Infections and infestations,10021881,Genitourinary tract infections and inflammations NEC,10018191,Ancillary infectious topics,10002252,-20,31OCT2006,-20,,2006-12-04,15,04DEC2006,15,,35,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-14-117,117,14,ARM A,1,ARM A,1,Y,Y,Y,Y,20NOV2006,14FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-31,TOOTHACHE,TOOTHACHE,10044055,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,Dental pain and sensation disorders,10044049,Abdominal hernias and other abdominal wall conditions,10000073,42,31DEC2006,42,,2007-01-10,52,10JAN2007,52,,11,,Y,Y,,Y,Y,,,,
BBC,BBC-14-117,117,14,ARM A,1,ARM A,1,Y,Y,Y,Y,20NOV2006,14FEB2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2006-12-03,UPPER RESPIRATORY INFECTION,UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,14,03DEC2006,14,,2006-12-07,18,07DEC2006,18,,5,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-14-123,123,14,ARM A,1,ARM A,1,Y,Y,Y,Y,19DEC2006,12MAR2007,1,MODERATE,2,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-03,LOW POTASSIUM,BLOOD POTASSIUM DECREASED,10005724,Investigations,10022891,Investigations,10022891,Mineral and electrolyte analyses,10027637,Cardiac and vascular investigations (excl enzyme tests),10007512,16,03JAN2007,16,,2007-03-13,85,13MAR2007,85,,70,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-14-124,124,14,ARM B,2,ARM B,2,Y,Y,Y,Y,28DEC2006,21MAR2007,1,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-02,ACUTE PARONYCHIA S/P TRAUMA,PARONYCHIA,10034016,Infections and infestations,10021881,Infections and infestations,10021881,Skin structures and soft tissue infections,10040786,Ancillary infectious topics,10002252,6,02JAN2007,6,,2007-01-15,19,15JAN2007,19,,14,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-15-153,153,15,ARM D,4,ARM D,4,Y,Y,Y,N,04JAN2007,17FEB2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-27,BACK PAIN,BACK PAIN,10003988,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,24,27JAN2007,24,,2007-01-28,25,28JAN2007,25,,2,,Y,Y,,Y,Y,,,,
BBC,BBC-15-153,153,15,ARM D,4,ARM D,4,Y,Y,Y,N,04JAN2007,17FEB2007,2,MILD,1,POSSIBLY RELATED,RELATED,DRUG WITHDRAWN,DRUG WITHDRAWN,N,N,GENERAL ADVERSE EVENT,2007-02-10,INCREASED ITCHING,PRURITUS,10037087,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Pruritus NEC,10049293,Angioedema and urticaria,10002426,38,10FEB2007,38,,2007-03,,01MAR2007,57,D,20,,Y,Y,,Y,Y,Y,Y,,
BBC,BBC-15-153,153,15,ARM D,4,ARM D,4,Y,Y,Y,N,04JAN2007,17FEB2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-14,SINUS CONGESTION,SINUS CONGESTION,10040742,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Paranasal sinus disorders (excl infections and neoplasms),10040743,Bronchial disorders (excl neoplasms),10006436,11,14JAN2007,11,,2007-01-15,12,15JAN2007,12,,2,Y,Y,Y,,Y,Y,,,,
BBC,BBC-15-153,153,15,ARM D,4,ARM D,4,Y,Y,Y,N,04JAN2007,17FEB2007,4,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-16,URINARY TRACT INFECTION,URINARY TRACT INFECTION,10046571,Infections and infestations,10021881,Infections and infestations,10021881,Genitourinary tract infections and inflammations NEC,10018191,Ancillary infectious topics,10002252,13,16JAN2007,13,,2007-01-17,14,17JAN2007,14,,2,,Y,Y,Y,Y,Y,,,,
BBC,BBC-15-155,155,15,ARM A,1,ARM A,1,Y,Y,Y,Y,11JAN2007,05APR2007,1,MILD,1,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-15,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,5,15JAN2007,5,,2007-01-15,5,15JAN2007,5,,1,Y,Y,Y,Y,Y,Y,Y,,,
BBC,BBC-15-155,155,15,ARM A,1,ARM A,1,Y,Y,Y,Y,11JAN2007,05APR2007,2,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-20,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,41,20FEB2007,41,,2007-02-20,41,20FEB2007,41,,1,,,,,,,,,,
BBC,BBC-15-155,155,15,ARM A,1,ARM A,1,Y,Y,Y,Y,11JAN2007,05APR2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-03-02,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,51,02MAR2007,51,,2007-03-02,51,02MAR2007,51,,1,,,,,,,,,,
BBC,BBC-15-155,155,15,ARM A,1,ARM A,1,Y,Y,Y,Y,11JAN2007,05APR2007,4,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-03-18,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,67,18MAR2007,67,,2007-03-18,67,18MAR2007,67,,1,,,,,,,,,,
BBC,BBC-15-155,155,15,ARM A,1,ARM A,1,Y,Y,Y,Y,11JAN2007,05APR2007,5,MILD,1,NOT RELATED,NOT RELATED,NOT APPLICABLE,NOT APPLICABLE,N,N,GENERAL ADVERSE EVENT,2007-04-15,HEADACHE,HEADACHE,10019211,Nervous system disorders,10029205,Nervous system disorders,10029205,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,95,15APR2007,95,,2007-04-15,95,15APR2007,95,,1,,,,,,,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,1,MILD,1,PROBABLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-14,ERYTHEMA ON PLAQUES,APPLICATION SITE ERYTHEMA,10003041,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,Application and instillation site reactions,10003057,Fatal outcomes,10053172,4,14JAN2007,4,,,,,,,,Y,Y,Y,,Y,Y,Y,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,2,MILD,1,POSSIBLY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-19,ERYTHEMA PATCHES ON B/LT HANDS,ERYTHEMA,10015150,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Erythemas,10015151,Angioedema and urticaria,10002426,9,19JAN2007,9,,,,,,,,,,Y,,,Y,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,3,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-03-07,ITCHING REDNESS ON BOTTOMS OF BOTH FEET,ERYTHEMA,10015150,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Erythemas,10015151,Angioedema and urticaria,10002426,56,07MAR2007,56,,2007-03-10,59,10MAR2007,59,,4,,,,,,,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,4,MILD,1,DEFINITELY RELATED,RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-17,TINGLE / BURN SENSATION AT PLAQUE SITES,SKIN DISCOMFORT,10040830,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,Dermal and epidermal conditions NEC,10012424,Angioedema and urticaria,10002426,7,17JAN2007,7,,2007-02-23,44,23FEB2007,44,,38,,Y,Y,,Y,Y,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,6,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-03-24,"COLD (SORE THROAT, COUGH)",UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,73,24MAR2007,73,,,,,,,,,,,,,,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,5,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-02-21,HEAD COLD/SORE SCRATCHY THROAT,UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,42,21FEB2007,42,,2007-02-28,49,28FEB2007,49,,8,,,Y,,,Y,,,,
BBC,BBC-15-156,156,15,ARM B,2,ARM B,2,Y,Y,Y,N,11JAN2007,05APR2007,7,MODERATE,2,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-18,BLADDER INFECTION (URINARY),URINARY TRACT INFECTION,10046571,Infections and infestations,10021881,Infections and infestations,10021881,Genitourinary tract infections and inflammations NEC,10018191,Ancillary infectious topics,10002252,8,18JAN2007,8,,2007-02-28,49,28FEB2007,49,,42,,Y,Y,Y,Y,Y,,,,
BBC,BBC-16-046,046,16,ARM D,4,ARM D,4,Y,Y,Y,N,28DEC2006,27JAN2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-22,SCIATIC NERVE PAIN,SCIATICA,10039674,Nervous system disorders,10029205,Nervous system disorders,10029205,Intervertebral disc disorders NEC,10022635,Central nervous system infections and inflammations,10007951,26,22JAN2007,26,,2007-01-29,33,29JAN2007,33,,8,Y,Y,Y,Y,Y,Y,,,,
BBC,BBC-16-160,160,16,ARM D,4,ARM D,4,Y,Y,Y,Y,28DEC2006,19MAR2007,1,MILD,1,NOT RELATED,NOT RELATED,DOSE NOT CHANGED,DOSE NOT CHANGED,N,N,GENERAL ADVERSE EVENT,2007-01-21,SORE THROAT,THROAT IRRITATION,10043521,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,Oral soft tissue pain and paraesthesia,10031019,Bronchial disorders (excl neoplasms),10006436,25,21JAN2007,25,,2007-01-21,25,21JAN2007,25,,1,,Y,Y,,Y,Y,,,,
BBC,BBC-16-160,160,16,ARM D,4,ARM D,4,Y,Y,Y,Y,28DEC2006,19MAR2007,2,MILD,1,NOT RELATED,NOT RELATED,NOT APPLICABLE,NOT APPLICABLE,N,N,GENERAL ADVERSE EVENT,2006-12-28,URI,UPPER RESPIRATORY TRACT INFECTION,10046306,Infections and infestations,10021881,Infections and infestations,10021881,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,1,28DEC2006,1,,2007-01-01,5,01JAN2007,5,,5,Y,Y,Y,Y,Y,Y,,,,
