PUB_ID,VISIT,AEPAGENUM,AEDIAG,AEMDVER,AESOC,AEMDRA,LL_NAME,HL_NAME,HLG_NAME,AEONDT_DSP,AEONDATE,AESEVE,AESEVE_TXT,AEREL,AEREL_TXT,AEDRAD,AEDRADC,AEOUTC,AEOUTCC,AEOCDT_DSP,AEOCDATE,AETREATMENT,AEICH,AEICHC,AEDAIDS,AEDAIDSC,AEVISIT,AESAERCT,AESAERCTC
114-034,6001,1,Decreased Hgb,22.1,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),11JUL2017,11JUL2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,7,No,No
114-091,6001,1,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04JUN2017,04JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUN2017,07JUN2017,Medication,No,No,No,No,3,No,No
114-078,6002,2,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,02APR2017,02APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13APR2017,13APR2017,Medication,No,No,No,No,2,No,No
114-078,6003,3,Upper respiratory tract infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,MAY2017,15MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,MAY2017,15MAY2017,None,No,No,No,No,5,No,No
114-078,6004,4,ingrown toenails (bilateral great toes),22.1,Skin and subcutaneous tissue disorders,Ingrowing nail,Ingrown toe nail,Nail and nail bed conditions (excl infections and infestations),Skin appendage conditions,JUN2017,15JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,JUL2017,15JUL2017,"Medication, Procedure/Surgery",No,No,No,No,5,No,No
114-078,6005,5,chest discomfort likely due to gastric reflux,22.1,Gastrointestinal disorders,Duodenogastric reflux,Duodenogastric reflux,Gastrointestinal atonic and hypomotility disorders NEC,Gastrointestinal motility and defaecation conditions,26JUL2017,26JUL2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26JUL2017,26JUL2017,None,No,No,No,No,7,No,No
114-078,6006,6,bacterial vaginosis,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,03AUG2017,03AUG2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14AUG2017,14AUG2017,Medication,No,No,No,No,7,No,No
114-078,6007,7,"ingrown toenail, left great toe",22.1,Skin and subcutaneous tissue disorders,Ingrowing nail,Ingrown toe nail,Nail and nail bed conditions (excl infections and infestations),Skin appendage conditions,AUG2017,15AUG2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,DEC2017,15DEC2017,None,No,No,No,No,8,No,No
114-078,6008,8,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,23JAN2018,23JAN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,9,No,No
114-042,6001,1,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08APR2017,08APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15APR2017,15APR2017,None,No,No,No,No,4,No,No
114-042,6002,2,Hematuria,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,10APR2017,10APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,24APR2017,24APR2017,None,No,No,No,No,4,No,No
114-042,6003,3,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,21APR2017,21APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAY2017,01MAY2017,Medication,No,No,No,No,4.1,No,No
114-042,6004,4,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,02OCT2017,02OCT2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06OCT2017,06OCT2017,None,No,No,No,No,8,No,No
114-042,6005,5,headache,22.1,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,01SEP2017,01SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15MAR2018,15MAR2018,None,No,No,No,No,8,No,No
114-042,6006,6,Fatigue,22.1,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,23NOV2017,23NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30MAY2018,30MAY2018,None,No,No,No,No,8,No,No
114-042,6007,7,Joint Aches,22.1,Musculoskeletal and connective tissue disorders,Arthralgia,Joint ache,Joint related signs and symptoms,Joint disorders,23NOV2017,23NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09AUG2018,09AUG2018,None,No,No,No,No,8,No,No
114-042,6008,8,Photophobia to Light at night,22.1,Eye disorders,Photophobia,Photophobia,Ocular sensation disorders,Ocular sensory symptoms NEC,23NOV2017,23NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,MAY2018,15MAY2018,None,No,No,No,No,8,No,No
114-042,6009,9,Trouble Sleeping,22.1,Psychiatric disorders,Insomnia,Difficulty sleeping,Disturbances in initiating and maintaining sleep,Sleep disorders and disturbances,23NOV2017,23NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,8,No,No
114-042,6010,10,Chronic Vaginal Bleeding,22.1,Reproductive system and breast disorders,Vaginal haemorrhage,Vaginal bleeding,Vulvovaginal disorders NEC,Vulvovaginal disorders (excl infections and inflammations),23NOV2017,23NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,JUL2018,15JUL2018,None,No,No,No,No,8,No,No
114-048,6001,1,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,DEC2017,15DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,DEC2017,15DEC2017,Medication,No,No,No,No,9,No,No
114-057,6001,1,lightheadedness,22.1,Nervous system disorders,Dizziness,Lightheadedness,Neurological signs and symptoms NEC,Neurological disorders NEC,01MAY2017,01MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAY2017,01MAY2017,None,No,No,No,No,2,No,No
114-009,6001,1,Viral syndrome,22.1,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,18OCT2017,18OCT2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21OCT2017,21OCT2017,None,No,No,No,No,5.1,No,No
114-020,6001,1,URI,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27FEB2018,27FEB2018,Mild,Mild,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,07MAR2018,07MAR2018,None,No,No,No,No,5,No,No
114-084,6001,1,pressumed hemorroid anal lession,22.1,Gastrointestinal disorders,Haemorrhoids,Hemorrhoids,Haemorrhoids and gastrointestinal varices (excl oesophageal),Gastrointestinal vascular conditions,06NOV2017,06NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,4,No,No
114-083,6001,1,DENTAL CARIES,22.1,Gastrointestinal disorders,Dental caries,Dental caries,Dental and periodontal infections and inflammations,Dental and gingival conditions,04AUG2017,04AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,11AUG2017,11AUG2017,None,No,No,No,No,4,No,No
114-062,6001,1,ACUTE DIARRHEAL DISEASE,22.1,Gastrointestinal disorders,Diarrhoea,Acute diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,09AUG2017,09AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,13AUG2017,13AUG2017,Medication,No,No,No,No,3,No,No
114-062,6002,2,HEMATURIA,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,18AUG2017,18AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,24NOV2017,24NOV2017,None,No,No,No,No,4,No,No
114-062,6003,3,ACUTE BRONCHITIS,22.1,Infections and infestations,Bronchitis,Acute bronchitis,Lower respiratory tract and lung infections,Infections - pathogen unspecified,02SEP2017,02SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,11SEP2017,11SEP2017,Medication,No,No,No,No,4.1,No,No
114-062,6004,4,HEMATURIA,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,24NOV2017,24NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01DEC2017,01DEC2017,None,No,No,No,No,5,No,No
114-062,6005,5,HEMATURIA,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,07DEC2017,07DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02FEB2018,02FEB2018,None,No,No,No,No,7,No,No
114-062,6006,6,INCREASED OF AST,22.1,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,15FEB2018,15FEB2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06MAR2018,06MAR2018,None,No,No,No,No,8,No,No
114-062,6007,7,ATOPIC DERMATITIS,22.1,Skin and subcutaneous tissue disorders,Dermatitis atopic,Atopic dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,01MAR2018,01MAR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15JUN2018,15JUN2018,Medication,No,No,No,No,9,No,No
114-067,6002,2,BACTERIAL VAGINOSIS,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,16JAN2018,16JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06FEB2018,06FEB2018,Medication,No,No,No,No,5,No,No
114-095,6001,1,RENAL STONE,22.1,Renal and urinary disorders,Nephrolithiasis,Renal stone,Renal lithiasis,Urolithiases,27DEC2017,27DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,7,No,No
114-069,6001,1,BACTERIAL URINARY TRACT INFECTION,22.1,Infections and infestations,Urinary tract infection bacterial,Urinary tract infection bacterial,Bacterial infections NEC,Bacterial infectious disorders,29JAN2018,29JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16APR2018,16APR2018,None,No,No,No,No,7,No,No
114-064,6001,1,Elevated AST,22.1,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,19SEP2017,19SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01NOV2017,01NOV2017,None,No,No,No,No,8,No,No
114-064,6002,2,Elevated ALT,22.1,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,19SEP2017,19SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01NOV2017,01NOV2017,None,No,No,No,No,8,No,No
114-082,6001,1,Oral Apthous ulcer,22.1,Gastrointestinal disorders,Aphthous ulcer,Ulcer aphthous oral,Stomatitis and ulceration,Oral soft tissue conditions,29MAR2017,29MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02APR2017,02APR2017,None,No,No,No,No,2.1,No,No
114-082,6002,2,Vulvar Dermatitis,22.1,Skin and subcutaneous tissue disorders,Dermatitis,Dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,29MAR2017,29MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11APR2017,11APR2017,None,No,No,No,No,2.1,No,No
114-060,6001,1,Open non displaced fracture to right proximal phalanx,22.1,"Injury, poisoning and procedural complications",Hand fracture,Fractured finger,Limb fractures and dislocations,Bone and joint injuries,17JUL2017,17JUL2017,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,19SEP2017,19SEP2017,"Medication, Procedure/Surgery",No,No,No,No,5,No,No
114-054,6001,1,abdominal pain,22.1,Gastrointestinal disorders,Abdominal pain,Abdominal pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,09JUN2018,09JUN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09JUN2018,09JUN2018,Medication,No,No,No,No,9,No,No
114-054,6002,2,acute allergic reaction,22.1,Immune system disorders,Hypersensitivity,Acute allergic reaction,Allergic conditions NEC,Allergic conditions,09JUN2018,09JUN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12JUN2018,12JUN2018,Medication,No,No,No,No,9,No,No