STUDYID,DOMAIN,USUBJID,AESEQ,AETERM,AELLT,AELLTCD,AEDECOD,AEPTCD,AEHLT,AEHLTCD,AEHLGT,AEHLGTCD,AECAT,AEBODSYS,AEBDSYCD,AESOC,AESOCCD,AESEV,AESER,AEACN,AEREL,AEOUT,AESTDTC,AEENDTC,AESTDY,AEENDY
ABC,AE,ABC-01-049,1,ELEVATED  GLUCOSE,,,BLOOD GLUCOSE INCREASED,10005557,Carbohydrate tolerance analyses (incl diabetes),10007217,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-28,2007-03-13,52,127
ABC,AE,ABC-01-049,2,ELEVATED TRIGLYCERIDES,,,BLOOD TRIGLYCERIDES INCREASED,10005839,Triglyceride analyses,10044657,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-28,2007-03-13,52,127
ABC,AE,ABC-01-049,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007,2007,,
ABC,AE,ABC-01-049,4,ELEVATED GLUCOSE AND TRIGYCERIDES,,,LABORATORY TEST ABNORMAL,10023547,Investigations NEC,10022892,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-11,2007-03-13,66,127
ABC,AE,ABC-01-049,5,BODY ACHES,,,MUSCULOSKELETAL DISCOMFORT,10053156,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007,2007,,
ABC,AE,ABC-01-050,1,GROIN RASH,,,RASH,10037844,"Rashes, eruptions and exanthems NEC",10052566,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-08,2006-11-15,7,14
ABC,AE,ABC-01-050,2,STUFFY NOSE,,,UPPER RESPIRATORY TRACT CONGESTION,10052252,Upper respiratory tract signs and symptoms,10046313,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-17,2006-12-17,46,46
ABC,AE,ABC-01-051,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-01,2007-01-01,61,61
ABC,AE,ABC-01-051,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-06,2007-03-09,125,128
ABC,AE,ABC-01-051,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-11-12,2007-11-14,376,378
ABC,AE,ABC-01-051,4,FLU,,,INFLUENZA LIKE ILLNESS,10022004,General signs and symptoms NEC,10018072,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-17,2006-11-19,16,18
ABC,AE,ABC-01-051,5,"FLU+COLD SYMPTOMS, SORENESS, VOMITING",,,INFLUENZA LIKE ILLNESS,10022004,General signs and symptoms NEC,10018072,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-20,2006-11-26,19,25
ABC,AE,ABC-01-051,6,TIGHT CHEST/SWOLLEN GLANDS,,,LOWER RESPIRATORY TRACT INFLAMMATION,10057260,Lower respiratory tract inflammatory and immunologic conditions,10024972,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-02,2006-11-08,1,7
ABC,AE,ABC-01-051,7,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-18,2007-03-24,137,143
ABC,AE,ABC-01-052,1,TINGLING WHEN STUDY DRUG IS APPLIED TO SKIN,,,APPLICATION SITE HYPERSENSITIVITY,10063683,Application and instillation site reactions,10003057,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,PROBABLY RELATED,RECOVERED/RESOLVED,2006-12-06,2006-12-11,31,36
ABC,AE,ABC-01-052,2,EXOSTECTOMY LEFT 1ST TARSOMETATARSAL OSTEOPHYLE,,,BONE LESION EXCISION,10005978,Bone therapeutic procedures NEC,10006000,Vascular therapeutic procedures,10003184,GENERAL ADVERSE EVENT,Surgical and medical procedures,10042613,Surgical and medical procedures,10042613,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-22,2006-12-22,47,47
ABC,AE,ABC-01-052,3,NEUTROPENIA,,,NEUTROPENIA,10029354,Neutropenias,10029355,Anaemias nonhaemolytic and marrow depression,10002086,GENERAL ADVERSE EVENT,Blood and lymphatic system disorders,10005329,Blood and lymphatic system disorders,10005329,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-27,2006-11-29,22,24
ABC,AE,ABC-01-055,1,ABNORMAL LABS (NEUTROPHILS),,,LABORATORY TEST ABNORMAL,10023547,Investigations NEC,10022892,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-25,2007-01-26,51,52
ABC,AE,ABC-01-055,2,SKIN IRRITATION AROUND NECK,,,SKIN IRRITATION,10040880,Dermatitis and eczema,10012435,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,DOSE REDUCED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-01-20,2007-02-09,46,66
ABC,AE,ABC-01-055,3,URI WITH SORE THROAT,,,UPPER RESPIRATORY FUNGAL INFECTION,10062219,Fungal infections NEC,10017536,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-23,2007-03-30,108,115
ABC,AE,ABC-01-055,4,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-11,2006-12-15,6,10
ABC,AE,ABC-01-056,1,FEVER,,,BODY TEMPERATURE INCREASED,10005911,Physical examination procedures,10034989,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-26,2006-12-27,29,30
ABC,AE,ABC-01-056,2,SINUS CONGESTION,,,SINUS CONGESTION,10040742,Paranasal sinus disorders (excl infections and neoplasms),10040743,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-01,2007-01-03,35,37
ABC,AE,ABC-01-113,1,LEFT LC TEAR REPAIR,,,SHOULDER OPERATION,10062242,Joint therapeutic procedures,10023221,Vascular therapeutic procedures,10003184,GENERAL ADVERSE EVENT,Surgical and medical procedures,10042613,Surgical and medical procedures,10042613,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-12,2007-04-01,39,118
ABC,AE,ABC-01-114,1,BCC LEFT LEG,,,BASAL CELL CARCINOMA,10004146,Skin neoplasms malignant and unspecified (excl melanoma),10040901,Breast neoplasms benign (incl nipple),10006288,GENERAL ADVERSE EVENT,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-28,2006-12-28,15,15
ABC,AE,ABC-01-114,2,DERMOID CYST,,,DERMOID CYST,10012522,Neoplasms benign site unspecified NEC,10029106,Blood and lymphatic system disorders congenital,10005330,GENERAL ADVERSE EVENT,"Congenital, familial and genetic disorders",10010331,"Congenital, familial and genetic disorders",10010331,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-11,2007-01-24,29,42
ABC,AE,ABC-01-114,3,2 SCC'S LEFT LEG,,,SQUAMOUS CELL CARCINOMA OF SKIN,10041834,Skin neoplasms malignant and unspecified (excl melanoma),10040901,Breast neoplasms benign (incl nipple),10006288,GENERAL ADVERSE EVENT,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",10029104,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-28,2007-02-06,15,55
ABC,AE,ABC-01-114,4,UPSET STOMACH/VOMITING,,,VOMITING,10047700,Nausea and vomiting symptoms,10028817,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-03,2007-01-03,21,21
ABC,AE,ABC-02-034,1,INFLUENZA,,,INFLUENZA,10022000,Influenza viral infections,10022005,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-27,2007-01-03,63,70
ABC,AE,ABC-02-034,2,COLD SYMPTOMS,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-28,2006-11-29,34,35
ABC,AE,ABC-02-035,1,"HYPERTENSION, WORSENING OF",,,HYPERTENSION,10020772,Vascular hypertensive disorders NEC,10020774,Aneurysms and artery dissections,10002363,GENERAL ADVERSE EVENT,Vascular disorders,10047065,Vascular disorders,10047065,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-30,2006-12-28,31,59
ABC,AE,ABC-02-035,2,TYPE II DIABETES,,,INSULIN-REQUIRING TYPE II DIABETES MELLITUS,10049746,Diabetes mellitus (incl subtypes),10012602,Acid-base disorders,10000485,GENERAL ADVERSE EVENT,Metabolism and nutrition disorders,10027433,Metabolism and nutrition disorders,10027433,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2006-12-05,,36,
ABC,AE,ABC-02-036,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-26,2006-12-26,56,56
ABC,AE,ABC-02-036,2,COLD SYMPTOMS,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-02-14,2007-02-19,106,111
ABC,AE,ABC-02-036,3,COLD,,,RHINITIS,10039083,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-10-26,2006-11-03,-6,3
ABC,AE,ABC-02-037,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-16,2006-12-17,46,47
ABC,AE,ABC-02-037,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-06,2007-01-06,67,67
ABC,AE,ABC-02-037,3,SINUS HEADACHE ASSOCIATED WITH SEASONAL ALLERGIES,,,SINUS HEADACHE,10040744,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-17,2006-11-20,17,20
ABC,AE,ABC-02-037,4,SINUS HEADACHE DUE TO WORSENING SEASONAL ALLERGIES,,,SINUS HEADACHE,10040744,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-03,2006-12-03,33,33
ABC,AE,ABC-02-037,5,SINUS HEADACHE DUE TO WORSENING SEASONAL ALLERGIES,,,SINUS HEADACHE,10040744,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-13,2006-12-13,43,43
ABC,AE,ABC-02-037,6,SINUS HEADACHE,,,SINUS HEADACHE,10040744,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-13,2007-01-14,74,75
ABC,AE,ABC-02-037,7,HEADACHE DUE TO WORSENING SEASONAL ALLERGIES,,,SINUS HEADACHE,10040744,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-05,2006-11-12,5,12
ABC,AE,ABC-02-038,1,WORSENING OF ELEVATED BLOOD PRESSURE,,,BLOOD PRESSURE INCREASED,10005750,Vascular tests NEC (incl blood pressure),10047110,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-11,2007-02-07,29,87
ABC,AE,ABC-02-038,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-14,2006-11-14,2,2
ABC,AE,ABC-02-039,1,DIARRHEA,,,DIARRHOEA,10012735,Diarrhoea (excl infective),10012736,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MODERATE,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-11,2006-11-16,-4,2
ABC,AE,ABC-02-039,2,HYPERTENSION,,,HYPERTENSION,10020772,Vascular hypertensive disorders NEC,10020774,Aneurysms and artery dissections,10002363,GENERAL ADVERSE EVENT,Vascular disorders,10047065,Vascular disorders,10047065,SEVERE,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-02-07,2007-03-06,85,112
ABC,AE,ABC-02-039,3,AFEBRILE SINUS CONGESTION,,,SINUS CONGESTION,10040742,Paranasal sinus disorders (excl infections and neoplasms),10040743,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-06,2007-02-16,84,94
ABC,AE,ABC-02-039,4,VOMITING,,,VOMITING,10047700,Nausea and vomiting symptoms,10028817,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-11,2006-11-14,-4,-1
ABC,AE,ABC-02-040,1,SINUS BRADYCARDIA ON ECG,,,SINUS BRADYCARDIA,10040741,Supraventricular arrhythmias,10042600,Cardiac arrhythmias,10007521,GENERAL ADVERSE EVENT,Cardiac disorders,10007541,Cardiac disorders,10007541,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-01-18,2007-03-10,43,94
ABC,AE,ABC-02-110,1,DIARRHEA,,,DIARRHOEA,10012735,Diarrhoea (excl infective),10012736,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-03,2007-01-03,17,17
ABC,AE,ABC-02-110,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-08,2007-01-08,22,22
ABC,AE,ABC-02-110,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-21,2007-01-21,35,35
ABC,AE,ABC-02-110,4,MUSCLE PAIN DUE TO MOVING FURNITURE,,,MUSCLE TIGHTNESS,10049816,Muscle related signs and symptoms NEC,10028326,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-22,2006-12-23,5,6
ABC,AE,ABC-02-110,5,AFEBRILE COLD SYMPTOMS,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-01,2007-02-09,46,54
ABC,AE,ABC-02-112,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-08,2007-01-08,21,21
ABC,AE,ABC-02-112,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-22,2007-01-22,35,35
ABC,AE,ABC-02-112,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-05,2007-02-05,49,49
ABC,AE,ABC-02-112,4,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-02-22,2007-02-22,66,66
ABC,AE,ABC-02-112,5,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-03-08,2007-03-08,80,80
ABC,AE,ABC-03-002,1,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-28,2006-12-30,79,81
ABC,AE,ABC-03-004,1,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-23,2007-01-07,73,88
ABC,AE,ABC-03-089,1,CHEST PAIN,,,CHEST PAIN,10008479,Ischaemic coronary artery disorders,10011085,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MODERATE,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-02-26,2007-02-26,98,98
ABC,AE,ABC-03-089,2,TOOTHACHE,,,TOOTHACHE,10044055,Dental pain and sensation disorders,10044049,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-10,2007-02-11,82,83
ABC,AE,ABC-03-089,3,URINARY TRACT INFECTION,,,URINARY TRACT INFECTION,10046571,Genitourinary tract infections and inflammations NEC,10018191,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-18,2006-11-25,-3,5
ABC,AE,ABC-03-090,1,ITCHING OF UNTREATED AREAS,,,PRURITUS,10037087,Pruritus NEC,10049293,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2006-12-09,,4,
ABC,AE,ABC-03-091,1,BACKACHE,,,BACK PAIN,10003988,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-01-02,2007-01-03,14,15
ABC,AE,ABC-03-091,2,DEPRESSION,,,DEPRESSION,10012378,Depressive disorders,10012401,Adjustment disorders (incl subtypes),10001302,GENERAL ADVERSE EVENT,Psychiatric disorders,10037175,Psychiatric disorders,10037175,MODERATE,N,NOT APPLICABLE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-01-28,,40,
ABC,AE,ABC-03-091,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-12-30,2007-01-01,11,13
ABC,AE,ABC-03-091,4,NECK MUSCLE PAIN,,,NECK PAIN,10028836,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-12-20,2006-12-21,1,2
ABC,AE,ABC-03-091,5,RIGHT SOLE FISSURE,,,SKIN FISSURES,10040849,Dermal and epidermal conditions NEC,10012424,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-02-01,2007-02-14,44,57
ABC,AE,ABC-04-073,1,INFLAMMED CYST UNDER BRA LINE,,,CYST,10011732,Neoplasms benign site unspecified NEC,10029106,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-24,2006-12-31,55,62
ABC,AE,ABC-04-073,2,STIFF NECK,,,MUSCULOSKELETAL STIFFNESS,10052904,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2006-12-21,,52,
ABC,AE,ABC-04-073,3,RUNNY NOSE,,,RHINORRHOEA,10039101,Upper respiratory tract signs and symptoms,10046313,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-21,2006-11-21,22,22
ABC,AE,ABC-04-073,4,CUT ON INDEX FINGER ON LEFT HAND,,,SKIN LACERATION,10058818,Skin injuries NEC,10027699,Bone and joint injuries,10005942,GENERAL ADVERSE EVENT,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-17,2007-01-19,79,81
ABC,AE,ABC-04-075,1,LOW BACK PAIN,,,BACK PAIN,10003988,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-14,2006-11-22,6,14
ABC,AE,ABC-04-075,2,ELEVATED BLOOD PRESSURE,,,BLOOD PRESSURE INCREASED,10005750,Vascular tests NEC (incl blood pressure),10047110,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-12-04,2006-12-19,26,41
ABC,AE,ABC-04-075,3,ORAL THRUSH,,,ORAL CANDIDIASIS,10030963,Candida infections,10007134,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-11,,95,
ABC,AE,ABC-04-075,4,TOOTHACHE,,,TOOTHACHE,10044055,Dental pain and sensation disorders,10044049,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-08,,92,
ABC,AE,ABC-04-075,5,DARK URINE,,,URINE ABNORMALITY,10046607,Urinary abnormalities,10000196,Bladder and bladder neck disorders (excl calculi),10004994,GENERAL ADVERSE EVENT,Renal and urinary disorders,10038359,Renal and urinary disorders,10038359,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-20,2006-12-04,12,26
ABC,AE,ABC-04-075,6,DECREASED 25 HYDROXY VITAMIN D TOTAL,,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-09,,93,
ABC,AE,ABC-04-076,1,VERTIGO,,,VERTIGO,10047340,Inner ear signs and symptoms,10022398,Congenital ear disorders (excl deafness),10010449,GENERAL ADVERSE EVENT,Ear and labyrinth disorders,10013993,Ear and labyrinth disorders,10013993,MODERATE,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-02-02,2007-02-04,80,82
ABC,AE,ABC-04-077,1,INCREASED PARATHYROID,,,PARATHYROID DISORDER,10033942,Parathyroid disorders NEC,10033944,Endocrine and glandular disorders NEC,10052547,GENERAL ADVERSE EVENT,Endocrine disorders,10014698,Endocrine disorders,10014698,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-12,,90,
ABC,AE,ABC-04-077,2,COMMON COLD,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-11-28,2006-12-01,14,17
ABC,AE,ABC-04-077,3,WORSENING 25 HYDROXY VITAMIN D TOTAL,,,VITAMIN D ABNORMAL,10062188,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2006-12-27,,43,
ABC,AE,ABC-04-078,1,COMMON COLD,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-05,2007-03-12,55,90
ABC,AE,ABC-04-078,2,WORSENING OF HYDROXYVITAMIN D TOTAL,,,VITAMIN D ABNORMAL,10062188,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-01-25,,44,
ABC,AE,ABC-04-079,1,DECREASED PARATHYROID HORMONE,,,BLOOD PARATHYROID HORMONE DECREASED,10005702,Parathyroid analyses,10033954,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,PROBABLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-03-14,,87,
ABC,AE,ABC-04-079,2,ASTHMATIC BRONCHITIS,,,NONINFECTIVE BRONCHITIS,10062644,Bronchial conditions NEC,10006429,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-19,2007-01-07,2,21
ABC,AE,ABC-04-080,1,ABSCESSED TOOTH,,,TOOTH ABSCESS,10044016,Dental and periodontal infections and inflammations,10012325,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-31,2007-01-08,11,19
ABC,AE,ABC-04-125,1,STINGING UPON APPLICATION TO BILATERAL KNEES,,,APPLICATION SITE IRRITATION,10003046,Application and instillation site reactions,10003057,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,PROBABLY RELATED,RECOVERED/RESOLVED,2007-01-07,2007-01-07,10,10
ABC,AE,ABC-04-125,2,BRONCHITIS,,,BRONCHITIS,10006451,Lower respiratory tract infections NEC,10024971,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-09,2007-04-01,71,94
ABC,AE,ABC-04-125,3,GASTROENTERITIS,,,GASTROENTERITIS,10017888,Gastric and gastroenteric infections,10017887,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-11,2007-03-12,73,74
ABC,AE,ABC-04-125,4,SKIN LESION SCAPULAR AREA APPEARS CONSISTENT WITH BASEL CELL SKIN CANCER,,,SKIN LESION,10040882,Dermal and epidermal conditions NEC,10012424,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-09,,43,
ABC,AE,ABC-04-125,5,DECREASED HYDROXY VITAMIN D TOTAL,,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-09,,43,
ABC,AE,ABC-04-125,6,"DECREASED VITAMIN D 125, DIHYDROXY",,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-09,,43,
ABC,AE,ABC-04-126,1,DECREASED HYDROXY D TOTAL 25,,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-03-28,2007-04-23,86,112
ABC,AE,ABC-04-127,1,LEFT KNEE OSTEOARTHRITIS,,,OSTEOARTHRITIS,10031161,Osteoarthropathies,10057178,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,SEVERE,Y,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-04-24,2007-04-28,112,116
ABC,AE,ABC-04-127,2,PRODUCTIVE COUGH,,,PRODUCTIVE COUGH,10036790,Coughing and associated symptoms,10011233,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-03,2007-01-04,1,2
ABC,AE,ABC-04-128,1,COMMON COLD,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,UNKNOWN,2006-12-31,,-4,
ABC,AE,ABC-04-129,1,INCREASED BLOOD PRESSURE,,,BLOOD PRESSURE INCREASED,10005750,Vascular tests NEC (incl blood pressure),10047110,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-02-14,2007-03-29,41,84
ABC,AE,ABC-04-129,2,ST SEGMENT CHANGES ON ELECTROCARDIOGRAM,,,ELECTROCARDIOGRAM CHANGE,10061116,ECG investigations,10053104,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,NOT APPLICABLE,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-03-29,2007-04-27,84,113
ABC,AE,ABC-04-129,3,COLD SORE,,,HERPES SIMPLEX,10019948,Herpes viral infections,10019972,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-01-12,2007-02-07,8,34
ABC,AE,ABC-04-129,4,DECREASED HYDROXY VITAMIN D TOTAL,,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-15,,42,
ABC,AE,ABC-04-130,1,DECREASED HYDROXY D TOTAL,,,VITAMIN D DECREASED,10062189,Vitamin analyses,10047598,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-20,,44,
ABC,AE,ABC-04-131,1,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-03-07,2007-03-17,57,67
ABC,AE,ABC-06-065,1,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-08,2006-11-22,1,15
ABC,AE,ABC-06-066,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-22,2006-11-23,9,10
ABC,AE,ABC-06-066,2,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-14,2006-11-28,1,15
ABC,AE,ABC-06-067,1,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-21,2006-12-04,1,14
ABC,AE,ABC-06-068,1,PNEUMONIA,,,PNEUMONIA,10035664,Lower respiratory tract infections NEC,10024971,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-11-30,2006-12-08,9,17
ABC,AE,ABC-06-068,2,SINUS INFECTION,,,SINUSITIS,10040753,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-18,2007-01-27,58,67
ABC,AE,ABC-06-068,3,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-21,2007-01-08,30,48
ABC,AE,ABC-06-070,1,"VOMITING, DIARRHEA - PER SUBJECT, SECONDARY TO ""FOOD POISONING""",,,FOOD POISONING,10016952,Gastrointestinal disorders NEC,10017948,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-15,2007-02-16,79,80
ABC,AE,ABC-06-070,2,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-12-05,2006-12-13,7,15
ABC,AE,ABC-06-071,1,ANXIETY,,,ANXIETY,10002855,Anxiety symptoms,10002869,Adjustment disorders (incl subtypes),10001302,GENERAL ADVERSE EVENT,Psychiatric disorders,10037175,Psychiatric disorders,10037175,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-01-26,,59,
ABC,AE,ABC-06-071,2,MIGRAINE HEADACHE,,,MIGRAINE,10027599,Cerebrovascular and spinal vascular disorders NEC,10008193,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-28,2007-01-29,61,62
ABC,AE,ABC-06-071,3,HEART PALPITATION,,,PALPITATIONS,10033557,Cardiac signs and symptoms NEC,10007609,Cardiac arrhythmias,10007521,GENERAL ADVERSE EVENT,Cardiac disorders,10007541,Cardiac disorders,10007541,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-21,2007-03-21,113,113
ABC,AE,ABC-06-071,4,RASH,,,RASH,10037844,"Rashes, eruptions and exanthems NEC",10052566,Angioedema and urticaria,10002426,GENERAL ADVERSE EVENT,Skin and subcutaneous tissue disorders,10040785,Skin and subcutaneous tissue disorders,10040785,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-12-13,2006-12-28,15,30
ABC,AE,ABC-06-071,5,TOOTHACHE,,,TOOTHACHE,10044055,Dental pain and sensation disorders,10044049,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,MILD,N,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2006-12-02,2006-12-05,4,7
ABC,AE,ABC-06-072,1,STINGING OF PSORIATIC PLAQUES FOR 10 MINUTES POST- APPLICATION,,,APPLICATION SITE IRRITATION,10003046,Application and instillation site reactions,10003057,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,DEFINITELY RELATED,RECOVERED/RESOLVED,2007-01-18,2007-02-28,45,86
ABC,AE,ABC-06-072,2,MYALGIA,,,MYALGIA,10028411,Muscle pains,10028323,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-22,2007-01-26,49,53
ABC,AE,ABC-06-072,3,PAIN FROM FALL ON ICE REQUIRING EMERGENCY ROOM VISIT,,,PAIN,10033371,Pain and discomfort NEC,10033372,Fatal outcomes,10053172,GENERAL ADVERSE EVENT,General disorders and administration site conditions,10018065,General disorders and administration site conditions,10018065,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-04,2007-02-04,62,62
ABC,AE,ABC-06-162,1,HYPOKALEMIA,,,BLOOD POTASSIUM DECREASED,10005724,Mineral and electrolyte analyses,10027637,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-11,2007-01-18,15,22
ABC,AE,ABC-06-162,2,GASTROENTERITIS,,,GASTROENTERITIS,10017888,Gastric and gastroenteric infections,10017887,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-31,2007-01-01,4,5
ABC,AE,ABC-06-162,3,BOWEL OBSTRUCTION,,,INTESTINAL OBSTRUCTION,10022687,Gastrointestinal stenosis and obstruction NEC,10018009,Abdominal hernias and other abdominal wall conditions,10000073,GENERAL ADVERSE EVENT,Gastrointestinal disorders,10017947,Gastrointestinal disorders,10017947,SEVERE,Y,NOT APPLICABLE,NOT RELATED,RECOVERED/RESOLVED,2007-04-06,2007-04-10,100,104
ABC,AE,ABC-06-162,4,UPPER RESPIRATORY INFECTION,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-03-11,2007-03-16,74,79
ABC,AE,ABC-06-163,1,SINUS PAIN/HEADACHE,,,SINUSITIS,10040753,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-19,2007-03-05,43,57
ABC,AE,ABC-07-009,1,BRONCHITIS,,,BRONCHITIS,10006451,Lower respiratory tract infections NEC,10024971,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-18,2007-12-23,62,432
ABC,AE,ABC-07-012,1,COUGH,,,COUGH,10011224,Coughing and associated symptoms,10011233,Bronchial disorders (excl neoplasms),10006436,GENERAL ADVERSE EVENT,"Respiratory, thoracic and mediastinal disorders",10038738,"Respiratory, thoracic and mediastinal disorders",10038738,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-11,2007-01-16,30,35
ABC,AE,ABC-07-016,1,ELEVATED PTH,,,BLOOD PARATHYROID HORMONE INCREASED,10005703,Parathyroid analyses,10033954,Cardiac and vascular investigations (excl enzyme tests),10007512,GENERAL ADVERSE EVENT,Investigations,10022891,Investigations,10022891,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-26,2007-01-08,1,14
ABC,AE,ABC-08-101,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-08,2006-11-08,2,2
ABC,AE,ABC-08-101,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-13,2006-11-13,7,7
ABC,AE,ABC-08-102,1,BACKACHE,,,BACK PAIN,10003988,Musculoskeletal and connective tissue signs and symptoms NEC,10027688,Bone disorders (excl congenital and fractures),10005959,GENERAL ADVERSE EVENT,Musculoskeletal and connective tissue disorders,10028395,Musculoskeletal and connective tissue disorders,10028395,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-14,2006-12-14,36,36
ABC,AE,ABC-08-102,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-09,2006-11-09,1,1
ABC,AE,ABC-08-102,3,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-12-18,2006-12-18,40,40
ABC,AE,ABC-08-102,4,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-12-31,2007-01-24,53,77
ABC,AE,ABC-08-103,1,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-01-10,2007-01-24,63,77
ABC,AE,ABC-08-104,1,GASTROENTERITIS,,,GASTROENTERITIS,10017888,Gastric and gastroenteric infections,10017887,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-02-03,2007-02-08,87,92
ABC,AE,ABC-08-105,1,SPRAINED ANKLE,,,JOINT SPRAIN,10023229,Joint related disorders NEC,10027685,Bone and joint injuries,10005942,GENERAL ADVERSE EVENT,"Injury, poisoning and procedural complications",10022117,"Injury, poisoning and procedural complications",10022117,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,UNKNOWN,2006-12-27,,45,
ABC,AE,ABC-08-106,1,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-12-04,2006-12-04,21,21
ABC,AE,ABC-08-106,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-12-09,2006-12-09,26,26
ABC,AE,ABC-08-106,3,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2006-11-17,2006-12-17,4,34
ABC,AE,ABC-08-106,4,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,POSSIBLY RELATED,RECOVERED/RESOLVED,2007-02-19,2007-02-26,98,105
ABC,AE,ABC-08-108,1,URI,,,UPPER RESPIRATORY TRACT INFECTION,10046306,Upper respiratory tract infections NEC,10045573,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-26,,5,
ABC,AE,ABC-08-108,2,UTI,,,URINARY TRACT INFECTION,10046571,Genitourinary tract infections and inflammations NEC,10018191,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,UNKNOWN,2006-12-22,,1,
ABC,AE,ABC-09-139,1,INSOMNIA,,,INSOMNIA,10022437,Disturbances in initiating and maintaining sleep,10013510,Adjustment disorders (incl subtypes),10001302,GENERAL ADVERSE EVENT,Psychiatric disorders,10037175,Psychiatric disorders,10037175,MILD,N,DOSE NOT CHANGED,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-13,,85,
ABC,AE,ABC-09-139,2,COMMON COLD,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-11,2007-01-18,52,59
ABC,AE,ABC-09-139,3,COMMON COLD,,,RESPIRATORY TRACT INFECTION,10062352,Infections NEC,10021902,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MODERATE,N,NOT APPLICABLE,NOT RELATED,NOT RECOVERED/NOT RESOLVED,2007-02-14,,86,
ABC,AE,ABC-09-140,1,ABSCESS (LEFT BREAST),,,BREAST ABSCESS,10006171,Breast infections,10006261,Ancillary infectious topics,10002252,GENERAL ADVERSE EVENT,Infections and infestations,10021881,Infections and infestations,10021881,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2007-01-19,2007-01-21,53,55
ABC,AE,ABC-09-140,2,HEADACHE,,,HEADACHE,10019211,Headaches NEC,10019233,Central nervous system infections and inflammations,10007951,GENERAL ADVERSE EVENT,Nervous system disorders,10029205,Nervous system disorders,10029205,MILD,N,DOSE NOT CHANGED,NOT RELATED,RECOVERED/RESOLVED,2006-12-04,2006-12-04,7,7
