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
108-331,6010,10,Dyspnea,23.0,"Respiratory, thoracic and mediastinal disorders",Dyspnoea,Dyspnea,Breathing abnormalities,Respiratory disorders NEC,29MAR2017,29MAR2017,Mild,Mild,Related,Related,Held,Held,Resolved,Resolved,30MAR2017,30MAR2017,None,No,No,No,No,4,No,No
108-029,6001,1,Dizziness,23.0,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,25SEP2017,25SEP2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,26SEP2017,26SEP2017,None,No,No,No,No,5,No,No
108-107,6001,1,Decreased hemoglobin,23.0,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),06NOV2017,06NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22DEC2017,22DEC2017,None,No,No,No,No,5,No,No
108-107,6002,2,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,19DEC2017,19DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,25DEC2017,25DEC2017,Medication,No,No,No,No,7,No,No
108-107,6003,3,Decreased Lymphocytes,23.0,Investigations,Lymphocyte count decreased,Lymphocyte count decreased,White blood cell analyses,Haematology investigations (incl blood groups),22DEC2017,22DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,7,No,No
108-022,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20NOV2017,20NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,19FEB2018,19FEB2018,Medication,No,No,No,No,3,No,No
108-022,6002,2,Otitis Externa,23.0,Infections and infestations,Otitis externa,Otitis externa,Ear infections,Infections - pathogen unspecified,11DEC2017,11DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,20DEC2017,20DEC2017,None,No,No,No,No,4,No,No
108-022,6003,3,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,27DEC2017,27DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JAN2018,30JAN2018,None,No,No,No,No,5,No,No
108-076,6001,1,Decreased platelet count,23.0,Investigations,Platelet count decreased,Platelet count decreased,Platelet analyses,Haematology investigations (incl blood groups),15MAY2018,15MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19JUL2018,19JUL2018,None,No,No,No,No,5,No,No
108-076,6002,2,Elevated BP,23.0,Investigations,Blood pressure increased,Elevated BP,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),19JUL2018,19JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,12SEP2018,12SEP2018,None,No,No,No,No,7,No,No
108-076,6003,3,Elevated BP,23.0,Investigations,Blood pressure increased,Elevated BP,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),19SEP2018,19SEP2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26SEP2018,26SEP2018,None,No,No,No,No,9,No,No
108-502,6001,1,Right Knee Pain,23.0,Musculoskeletal and connective tissue disorders,Arthralgia,Knee pain,Joint related signs and symptoms,Joint disorders,22MAY2018,22MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02JUN2018,02JUN2018,None,No,No,No,No,3,No,No
108-502,6002,2,Pruritic Rash to Left Antecubital,23.0,Skin and subcutaneous tissue disorders,Rash pruritic,Pruritic rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,28MAY2018,28MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21JUN2018,21JUN2018,Medication,No,No,No,No,3,No,No
108-502,6003,3,Left knee pain,23.0,Musculoskeletal and connective tissue disorders,Arthralgia,Knee pain,Joint related signs and symptoms,Joint disorders,18JUN2018,18JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUN2018,25JUN2018,None,No,No,No,No,5,No,No
108-502,6004,4,Iron deficiency anemia,23.0,Blood and lymphatic system disorders,Iron deficiency anaemia,Iron deficiency anemia,Anaemia deficiencies,Anaemias nonhaemolytic and marrow depression,27JUN2018,27JUN2018,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,5,No,No
108-502,6005,5,Seasonal Allergies,23.0,Immune system disorders,Seasonal allergy,Seasonal allergy,Atopic disorders,Allergic conditions,22OCT2018,22OCT2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29OCT2018,29OCT2018,Medication,No,No,No,No,9,No,No
108-053,6001,1,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,02MAR2017,02MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13MAR2017,13MAR2017,Medication,No,No,No,No,5,No,No
108-111,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10APR2017,10APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21APR2017,21APR2017,Medication,No,No,No,No,6,No,No
108-295,6001,1,back strain,23.0,"Injury, poisoning and procedural complications",Muscle strain,Back strain,"Muscle, tendon and ligament injuries",Injuries NEC,23JUN2017,23JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26JUN2017,26JUN2017,Medication,No,No,No,No,5,No,No
108-295,6002,2,Pneumonia,23.0,Infections and infestations,Pneumonia,Pneumonia,Lower respiratory tract and lung infections,Infections - pathogen unspecified,15NOV2017,15NOV2017,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,08DEC2017,08DEC2017,"Medication, New/Prolonged Hospitalization, Other",Yes,Yes,Yes,Yes,7.1,No,No
108-154,6001,1,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15JUL2017,15JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30AUG2017,30AUG2017,None,No,No,No,No,5,No,No
108-106,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,16SEP2017,16SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19SEP2017,19SEP2017,Medication,No,No,No,No,7,No,No
108-155,6001,1,Localized maculopapular rash on left neck,23.0,Skin and subcutaneous tissue disorders,Rash maculo-papular,Localized maculopapular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,14JUN2017,14JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18JUL2017,18JUL2017,Medication,No,No,No,No,3,No,No
108-448,6001,1,Anxiety Exacerbation,23.0,Psychiatric disorders,Anxiety,Exacerbation of anxiety,Anxiety symptoms,Anxiety disorders and symptoms,OCT2017,15OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,OCT2017,15OCT2017,Other,No,No,No,No,8,No,No
108-448,6002,2,Depression Exacerbation,23.0,Psychiatric disorders,Depression,Depression aggravated,Depressive disorders,Depressed mood disorders and disturbances,OCT2017,15OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,OCT2017,15OCT2017,Other,No,No,No,No,8,No,No
108-448,6003,3,Gastroesophageal Reflux Disease Exacerbation,23.0,Gastrointestinal disorders,Gastrooesophageal reflux disease,Gastroesophageal reflux disease,Gastrointestinal atonic and hypomotility disorders NEC,Gastrointestinal motility and defaecation conditions,OCT2017,15OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,APR2018,15APR2018,Medication,No,No,No,No,8,No,No
108-448,6004,4,Vomiting,23.0,Gastrointestinal disorders,Vomiting,Vomiting,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,OCT2017,15OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,OCT2017,15OCT2017,None,No,No,No,No,8,No,No
108-448,6005,5,Nausea,23.0,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,OCT2017,15OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,FEB2018,15FEB2018,Medication,No,No,No,No,8,No,No
108-066,6001,1,Diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,22OCT2017,22OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22OCT2017,22OCT2017,None,No,No,No,No,7,No,No
108-512,6001,1,viral illness,23.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,20JAN2018,20JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28JAN2018,28JAN2018,None,No,No,No,No,10.1,No,No
108-494,6001,1,Pruritis at right arm injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,04JAN2018,04JAN2018,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,10JAN2018,10JAN2018,None,No,No,No,No,9,No,No
108-332,6001,1,neck strain,23.0,"Injury, poisoning and procedural complications",Muscle strain,Neck strain,"Muscle, tendon and ligament injuries",Injuries NEC,04JAN2018,04JAN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,05JAN2018,05JAN2018,Medication,No,No,No,No,9,No,No
108-018,6001,1,Gastroenteritis,23.0,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,31JAN2018,31JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02FEB2018,02FEB2018,None,No,No,No,No,10,No,No
108-018,6002,2,Increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,05FEB2018,05FEB2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11APR2018,11APR2018,None,No,No,No,No,10,No,No
108-426,6001,1,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04NOV2017,04NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13NOV2017,13NOV2017,Medication,No,No,No,No,4,No,No
108-426,6002,2,Left ankle sprain,23.0,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,04FEB2018,04FEB2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03APR2018,03APR2018,Other,No,No,No,No,8,No,No
108-110,6001,1,VIRAL ILLNESS,23.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,14DEC2017,14DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,27DEC2017,27DEC2017,Medication,No,No,No,No,3,No,No
108-110,6002,2,Increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,12MAR2018,12MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14MAY2018,14MAY2018,None,No,No,No,No,7,No,No
108-039,6001,1,decreased platelets,23.0,Investigations,Platelet count decreased,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),11JAN2018,11JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,24JAN2018,24JAN2018,None,No,No,No,No,3,No,No
108-039,6002,2,Increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,11JAN2018,11JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,18JAN2018,18JAN2018,None,No,No,No,No,3,No,No
108-039,6003,3,Increased ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,11JAN2018,11JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,18JAN2018,18JAN2018,None,No,No,No,No,3,No,No
108-039,6004,4,Increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,18JAN2018,18JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,29JAN2018,29JAN2018,None,No,No,No,No,3.1,No,No
108-039,6005,5,Increased ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,18JAN2018,18JAN2018,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,31JAN2018,31JAN2018,None,No,No,No,No,3.1,No,No
108-039,6007,7,Mononucleosis,23.0,Infections and infestations,Infectious mononucleosis,Mononucleosis,Epstein-Barr viral infections,Viral infectious disorders,18JAN2018,18JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,31JAN2018,31JAN2018,None,No,No,No,No,3.2,No,No
108-493,6001,1,Increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,15OCT2018,15OCT2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22JAN2019,22JAN2019,None,No,No,No,No,10,No,No
108-141,6001,1,Back Pain,23.0,Musculoskeletal and connective tissue disorders,Back pain,Back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,25JAN2017,25JAN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JAN2017,25JAN2017,Medication,No,No,No,No,4,No,No
108-141,6002,2,Left wrist tendonitis,23.0,Musculoskeletal and connective tissue disorders,Tendonitis,Tendonitis,Tendon disorders,"Tendon, ligament and cartilage disorders",01MAR2017,01MAR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,31MAR2017,31MAR2017,"Medication, Other",No,No,No,No,7,No,No
108-141,6003,3,Right tendonitis,23.0,Musculoskeletal and connective tissue disorders,Tendonitis,Tendonitis,Tendon disorders,"Tendon, ligament and cartilage disorders",28MAY2017,28MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15AUG2017,15AUG2017,Medication,No,No,No,No,8,No,No
108-031,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08MAR2017,08MAR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,11MAR2017,11MAR2017,Medication,No,No,No,No,3,No,No
108-474,6001,1,"Pruritis (on right arm, area around bicep)",23.0,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,03JUN2017,03JUN2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,05JUN2017,05JUN2017,None,No,No,No,No,4,No,No
108-459,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05DEC2017,05DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13DEC2017,13DEC2017,Medication,No,No,No,No,8,No,No
108-225,6001,1,Poison Ivy Dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis contact,Poison ivy rash,Dermatitis and eczema,Epidermal and dermal conditions,08AUG2017,08AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05SEP2017,05SEP2017,None,No,No,No,No,5,No,No
108-225,6002,2,Dizziness,23.0,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,11OCT2017,11OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13OCT2017,13OCT2017,None,No,No,No,No,6,No,No
108-152,6001,1,Dizziness,23.0,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,12JUL2017,12JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13JUL2017,13JUL2017,None,No,No,No,No,2,No,No
108-152,6002,2,Hot flashes,23.0,Vascular disorders,Hot flush,Hot flashes,Peripheral vascular disorders NEC,Vascular disorders NEC,12JUL2017,12JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14JUL2017,14JUL2017,None,No,No,No,No,2,No,No
108-152,6003,3,Dizziness,23.0,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,12OCT2017,12OCT2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,13OCT2017,13OCT2017,None,No,No,No,No,6,No,No
108-152,6005,5,increased AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,10JAN2018,10JAN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11APR2018,11APR2018,None,No,No,No,No,10,No,No
108-401,6001,1,Fever,23.0,General disorders and administration site conditions,Pyrexia,Fever,Febrile disorders,Body temperature conditions,11OCT2017,11OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11OCT2017,11OCT2017,None,No,No,No,No,6,No,No
108-207,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05SEP2017,05SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16SEP2017,16SEP2017,None,No,No,No,No,3,No,No
108-385,6001,1,Left Foot Injury,23.0,"Injury, poisoning and procedural complications",Limb injury,Foot injury,Site specific injuries NEC,Injuries NEC,30NOV2017,30NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,20DEC2017,20DEC2017,Medication,No,No,No,No,7,No,No
108-150,6001,1,Right ear infection,23.0,Infections and infestations,Ear infection,Ear infection,Ear infections,Infections - pathogen unspecified,28DEC2017,28DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,06JAN2018,06JAN2018,Medication,No,No,No,No,8,No,No
108-150,6002,2,Nausea,23.0,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,22FEB2018,22FEB2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24FEB2018,24FEB2018,None,No,No,No,No,10,No,No
108-125,6001,1,R UQ Abdominal Pain,23.0,Gastrointestinal disorders,Abdominal pain upper,Upper abdominal pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,17NOV2017,17NOV2017,Moderate,Moderate,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,10DEC2017,10DEC2017,None,No,No,No,No,4,No,No
108-506,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24OCT2017,24OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31OCT2017,31OCT2017,Medication,No,No,No,No,2,No,No
108-506,6002,2,Cellulitis of Right Foot,23.0,Infections and infestations,Cellulitis,Cellulitis of foot,Bacterial infections NEC,Bacterial infectious disorders,17NOV2017,17NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26NOV2017,26NOV2017,Medication,No,No,No,No,5,No,No
108-506,6003,3,diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,19JAN2018,19JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19JAN2018,19JAN2018,None,No,No,No,No,7,No,No
108-490,6001,1,Elevated creatinine level,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,16MAY2018,16MAY2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,23MAY2018,23MAY2018,None,No,No,No,No,10,No,No
108-254,6001,1,Increased Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,06SEP2018,06SEP2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,None,No,No,No,No,10,No,No
108-251,6001,1,increased creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,02MAY2018,02MAY2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03JUL2018,03JUL2018,None,No,No,No,No,5,No,No
108-251,6002,2,Vaginal Candidiasis,23.0,Infections and infestations,Vulvovaginal candidiasis,Vaginal candidiasis,Candida infections,Fungal infectious disorders,01SEP2018,01SEP2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,03SEP2018,03SEP2018,Medication,No,No,No,No,9,No,No
108-310,6001,1,Furuncle,23.0,Infections and infestations,Furuncle,Furuncle,Staphylococcal infections,Bacterial infectious disorders,11JUN2018,11JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,18JUN2018,18JUN2018,Medication,No,No,No,No,7,No,No
108-305,6001,1,nasal bridge pain,23.0,"Injury, poisoning and procedural complications",Nasal injury,Nasal injury,Site specific injuries NEC,Injuries NEC,15APR2018,15APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15APR2018,15APR2018,Medication,No,No,No,No,4,No,No
108-467,6001,1,"xeroderma, face (left cheek)",23.0,Skin and subcutaneous tissue disorders,Xeroderma,Xeroderma,Ichthyoses,Cornification and dystrophic skin disorders,27JUN2017,27JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21JUL2017,21JUL2017,None,No,No,No,No,6,No,No
108-467,6002,2,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27SEP2017,27SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06OCT2017,06OCT2017,Medication,No,No,No,No,8,No,No
108-467,6003,3,conjunctivitis,23.0,Infections and infestations,Conjunctivitis,Conjunctivitis,Eye and eyelid infections,Infections - pathogen unspecified,AUG2017,15AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,AUG2017,15AUG2017,Medication,No,No,No,No,8,No,No
108-467,6004,4,neck pain,23.0,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,14OCT2017,14OCT2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,23OCT2017,23OCT2017,Medication,No,No,No,No,10,No,No
108-467,6008,8,symptomatic genitourinary chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,29MAR2018,29MAR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,13APR2018,13APR2018,Medication,No,No,No,No,12,No,No
108-524,6002,2,headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,16MAY2017,16MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,27MAY2017,27MAY2017,None,No,No,No,No,4,No,No
108-524,6004,4,"abnormal pap smear, LSIL",23.0,Reproductive system and breast disorders,Cervical dysplasia,LSIL,Cervix disorders NEC,Cervix disorders (excl infections and inflammations),22MAY2017,22MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07AUG2017,07AUG2017,Procedure/Surgery,No,No,No,No,5,No,No
108-524,6005,5,bilateral neck pain,23.0,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,30JUN2017,30JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,09OCT2017,09OCT2017,"Medication, Other",No,No,No,No,6,No,No
108-524,6006,6,irregular menses,23.0,Reproductive system and breast disorders,Menstruation irregular,Menses irregular,Menstruation and uterine bleeding NEC,Menstrual cycle and uterine bleeding disorders,23JUL2017,23JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,SEP2017,15SEP2017,None,No,No,No,No,7,No,No
108-524,6007,7,right upper extremity pain,23.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Pain in upper extremities,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,26APR2017,26APR2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,27APR2017,27APR2017,Medication,No,No,No,No,2,No,No
108-524,6008,8,right upper extremity pain,23.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Pain in upper extremities,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,23MAY2017,23MAY2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,24MAY2017,24MAY2017,None,No,No,No,No,4,No,No
108-077,6001,1,dental cavity,23.0,Gastrointestinal disorders,Dental caries,Dental cavity,Dental and periodontal infections and inflammations,Dental and gingival conditions,20MAY2017,20MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30MAY2017,30MAY2017,"Medication, Procedure/Surgery",No,No,No,No,3,No,No
108-077,6002,2,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24JUN2017,24JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,09JUL2017,09JUL2017,Medication,No,No,No,No,5,No,No
108-077,6003,3,Neck soreness,23.0,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,02AUG2017,02AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03AUG2017,03AUG2017,Medication,No,No,No,No,6,No,No
108-077,6004,4,Left Shoulder Pain,23.0,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,01SEP2017,01SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01OCT2017,01OCT2017,Medication,No,No,No,No,8,No,No
108-514,6001,1,sore throat,23.0,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,19JUL2017,19JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21JUL2017,21JUL2017,None,No,No,No,No,3,No,No
108-514,6002,2,burning of eyes,23.0,Eye disorders,Eye irritation,Burning eyes,"Ocular infections, inflammations and associated manifestations","Ocular infections, irritations and inflammations",03AUG2017,03AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04AUG2017,04AUG2017,None,No,No,No,No,4,No,No
108-019,6001,1,athletes feet (bilateral),23.0,Infections and infestations,Tinea pedis,Athlete's foot,Tinea infections,Fungal infectious disorders,17AUG2017,17AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25AUG2017,25AUG2017,Medication,No,No,No,No,4,No,No
108-019,6002,2,Asthma,23.0,"Respiratory, thoracic and mediastinal disorders",Asthma,Asthma,Bronchospasm and obstruction,Bronchial disorders (excl neoplasms),SEP2017,15SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,6,No,No
108-019,6003,3,tinea corporis,23.0,Infections and infestations,Body tinea,Tinea corporis,Tinea infections,Fungal infectious disorders,19OCT2017,19OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28OCT2017,28OCT2017,Medication,No,No,No,No,6,No,No
108-304,6001,1,Vasovagal Reaction Immediately post vaccination,23.0,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,11DEC2017,11DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11DEC2017,11DEC2017,None,No,No,No,No,2,No,No
108-304,6002,2,headaches,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,22DEC2017,22DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,23DEC2017,23DEC2017,None,No,No,No,No,3,No,No
108-304,6003,3,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,03JAN2018,03JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08JAN2018,08JAN2018,Medication,No,No,No,No,4,No,No
108-304,6004,4,Lichen simplex chronicus,23.0,Skin and subcutaneous tissue disorders,Neurodermatitis,Lichen simplex chronicus,Dermatitis and eczema,Epidermal and dermal conditions,15MAR2018,15MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAY2018,15MAY2018,Medication,No,No,No,No,8,No,No
108-354,6001,1,upper respiratory infection,23.0,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,No change,No change,Resolved,Resolved,28JAN2018,28JAN2018,Medication,No,No,No,No,4,No,No
108-354,6003,3,2.5cm X 2.5cm area of swelling upper anterior area of left shoulder (Diagnosed as LIPOMA on 7/2/18),23.0,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Lipoma,Lipoma,Soft tissue neoplasms benign NEC,Soft tissue neoplasms benign,26JUN2018,26JUN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26OCT2018,26OCT2018,None,No,No,No,No,9,No,No
108-308,6001,1,Vaginal Itching,23.0,Reproductive system and breast disorders,Vulvovaginal pruritus,Vaginal itching,Vulvovaginal signs and symptoms,Vulvovaginal disorders (excl infections and inflammations),05APR2018,05APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08APR2018,08APR2018,None,No,No,No,No,4,No,No
108-308,6002,2,Sharp Generalized Stomach Pain,23.0,Gastrointestinal disorders,Abdominal pain upper,Stomach pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,18APR2018,18APR2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18APR2018,18APR2018,Medication,No,No,No,No,4,No,No
108-308,6003,3,Hot Flashes,23.0,Vascular disorders,Hot flush,Hot flashes,Peripheral vascular disorders NEC,Vascular disorders NEC,18APR2018,18APR2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18APR2018,18APR2018,Medication,No,No,No,No,4,No,No
108-308,6004,4,Asymptomatic bacterial vaginosis,23.0,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,17SEP2018,17SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14OCT2018,14OCT2018,"Medication, Other",No,No,No,No,10,No,No
108-204,6001,1,"tinea corporis, right pointer finger",23.0,Infections and infestations,Body tinea,Tinea corporis,Tinea infections,Fungal infectious disorders,12JUN2018,12JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUN2018,25JUN2018,Medication,No,No,No,No,6,No,No
108-204,6002,2,eczema-bilateral hands,23.0,Skin and subcutaneous tissue disorders,Eczema,Eczema,Dermatitis and eczema,Epidermal and dermal conditions,AUG2018,15AUG2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15NOV2018,15NOV2018,Medication,No,No,No,No,8,No,No
108-204,6003,3,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,14SEP2018,14SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,05OCT2018,05OCT2018,Medication,No,No,No,No,9,No,No
108-443,6001,1,Striated Erythematous Rash Bilateral anterior Axilla,23.0,Skin and subcutaneous tissue disorders,Rash erythematous,Erythematous rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,10APR2018,10APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10OCT2018,10OCT2018,None,No,No,No,No,3,No,No
108-443,6002,2,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20JUN2018,20JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUN2018,30JUN2018,Medication,No,No,No,No,5,No,No
108-443,6003,3,upper back pain,23.0,Musculoskeletal and connective tissue disorders,Back pain,Upper back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,07JUN2018,07JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,29JUN2018,29JUN2018,Medication,No,No,No,No,6,No,No
108-518,6001,1,upper respiratory symptoms,23.0,"Respiratory, thoracic and mediastinal disorders",Respiratory symptom,Upper respiratory symptom,Respiratory signs and symptoms NEC,Respiratory tract signs and symptoms,18APR2018,18APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,29APR2018,29APR2018,Medication,No,No,No,No,2,No,No
108-518,6002,2,"Injection site itching, right deltoid (anterior)",23.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,10MAY2018,10MAY2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,13MAY2018,13MAY2018,Other,No,No,No,No,4,No,No
108-518,6003,3,"injection site warmth, right deltoid (anterior)",23.0,General disorders and administration site conditions,Injection site warmth,Injection site warmth,Injection site reactions,Administration site reactions,10MAY2018,10MAY2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,13MAY2018,13MAY2018,Other,No,No,No,No,4,No,No
108-011,6001,1,"cat bite, right hand",23.0,"Injury, poisoning and procedural complications",Animal bite,Cat bite,Non-site specific injuries NEC,Injuries NEC,03MAY2018,03MAY2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12JUN2018,12JUN2018,"Medication, Other",No,No,No,No,2,No,No
108-253,6001,1,diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,03MAY2018,03MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03MAY2018,03MAY2018,None,No,No,No,No,2,No,No
108-253,6002,2,abdominal pain,23.0,Gastrointestinal disorders,Abdominal pain,Abdominal pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,05MAY2018,05MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05MAY2018,05MAY2018,None,No,No,No,No,2,No,No
108-253,6003,3,night sweats,23.0,Skin and subcutaneous tissue disorders,Night sweats,Night sweats,Apocrine and eccrine gland disorders,Skin appendage conditions,06MAY2018,06MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08MAY2018,08MAY2018,None,No,No,No,No,3,No,No
108-253,6004,4,night sweats,23.0,Skin and subcutaneous tissue disorders,Night sweats,Night sweats,Apocrine and eccrine gland disorders,Skin appendage conditions,06JUN2018,06JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUN2018,07JUN2018,None,No,No,No,No,4,No,No
108-253,6005,5,"intermittent periods of cold hands, bilaterally",23.0,Vascular disorders,Peripheral coldness,Cold hands,"Peripheral vasoconstriction, necrosis and vascular insufficiency","Arteriosclerosis, stenosis, vascular insufficiency and necrosis",20MAY2018,20MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JUL2018,06JUL2018,None,No,No,No,No,5,No,No
108-253,6006,6,R shoulder pain,23.0,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,01AUG2018,01AUG2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02AUG2018,02AUG2018,None,No,No,No,No,6,No,No
108-253,6007,7,diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,01AUG2018,01AUG2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,02AUG2018,02AUG2018,None,No,No,No,No,6,No,No
108-253,6008,8,decreased appetite,23.0,Metabolism and nutrition disorders,Decreased appetite,Decreased appetite,Appetite disorders,Appetite and general nutritional disorders,01AUG2018,01AUG2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,02AUG2018,02AUG2018,None,No,No,No,No,6,No,No
108-253,6009,9,Mild uncomplicated dermatitis of right and left deltoids,23.0,Skin and subcutaneous tissue disorders,Dermatitis,Dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,10SEP2018,10SEP2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01DEC2018,01DEC2018,Medication,No,No,No,No,8,No,No
108-253,6010,10,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,07OCT2018,07OCT2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20OCT2018,20OCT2018,Medication,No,No,No,No,8,No,No
108-253,6011,11,loose stool,23.0,Gastrointestinal disorders,Diarrhoea,Loose stools,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,11OCT2018,11OCT2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11OCT2018,11OCT2018,None,No,No,No,No,8,No,No
108-253,6012,12,Vomiting,23.0,Gastrointestinal disorders,Vomiting,Vomiting,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,20OCT2018,20OCT2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20OCT2018,20OCT2018,None,No,No,No,No,10,No,No
108-253,6013,13,Diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,25OCT2018,25OCT2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,25OCT2018,25OCT2018,None,No,No,No,No,10,No,No
108-122,6003,3,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,23JUN2018,23JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUN2018,25JUN2018,Medication,No,No,No,No,5,No,No
108-122,6004,4,Elevated AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,27JUN2018,27JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUL2018,25JUL2018,None,No,No,No,No,5,No,No
108-122,6005,5,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,27JUN2018,27JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUL2018,25JUL2018,None,No,No,No,No,5,No,No
108-129,6001,1,Chemical Burn left calf area,23.0,"Injury, poisoning and procedural complications",Chemical burn of skin,Chemical burn of skin,Chemical injuries,"Exposures, chemical injuries and poisoning",06AUG2018,06AUG2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,09AUG2018,09AUG2018,Medication,No,No,No,No,4,No,No
108-129,6002,2,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,16DEC2018,16DEC2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,19DEC2018,19DEC2018,None,No,No,No,No,10,No,No
108-129,6003,3,Vasovagal reaction,23.0,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,19DEC2018,19DEC2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,19DEC2018,19DEC2018,None,No,No,No,No,10,No,No
108-069,6001,1,mass (right lower leg - anterior compartment),23.0,Musculoskeletal and connective tissue disorders,Limb mass,Limb mass,Musculoskeletal and connective tissue conditions NEC,Musculoskeletal and connective tissue disorders NEC,31AUG2018,31AUG2018,Mild,Mild,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,Other,No,No,No,No,6,No,No
108-069,6002,2,Nausea,23.0,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,08JAN2019,08JAN2019,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,10JAN2019,10JAN2019,None,No,No,No,No,10,No,No
108-069,6003,3,Vasovagal reaction,23.0,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,09JAN2019,09JAN2019,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09JAN2019,09JAN2019,None,No,No,No,No,10,No,No
108-069,6004,4,Depression,23.0,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,10JAN2019,10JAN2019,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,11,No,No
108-382,6001,1,abdominal pain,23.0,Gastrointestinal disorders,Abdominal pain,Abdominal pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,12AUG2018,12AUG2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14AUG2018,14AUG2018,Medication,No,No,No,No,4,No,No
108-272,6001,1,Right injection site pruritus,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,18FEB2017,18FEB2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,21FEB2017,21FEB2017,None,No,No,No,No,4.1,No,No
108-272,6003,3,Right scapula/trapezius muscle pain,23.0,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder blade pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,27FEB2017,27FEB2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,10MAR2017,10MAR2017,Medication,No,No,No,No,5,No,No
108-480,6001,1,viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,05JUN2017,05JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10JUN2017,10JUN2017,None,No,No,No,No,6,No,No
108-380,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,09JUN2017,09JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,22JUN2017,22JUN2017,Medication,No,No,No,No,5,No,No
108-056,6001,1,dermatitis L forearm,23.0,Skin and subcutaneous tissue disorders,Dermatitis,Dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,27JUL2017,27JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28JUL2017,28JUL2017,Medication,No,No,No,No,6.1,No,No
108-325,6001,1,Loose stool,23.0,Gastrointestinal disorders,Diarrhoea,Loose stools,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,07MAY2017,07MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,09MAY2017,09MAY2017,None,No,No,No,No,2.1,No,No
108-325,6002,2,Right arm soft tissue swelling,23.0,General disorders and administration site conditions,Peripheral swelling,Swelling arm,General signs and symptoms NEC,General system disorders NEC,27JUL2017,27JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28JUL2017,28JUL2017,Medication,No,No,No,No,6.1,No,No
108-160,6001,1,night sweat,23.0,Skin and subcutaneous tissue disorders,Night sweats,Night sweat,Apocrine and eccrine gland disorders,Skin appendage conditions,15JUL2017,15JUL2017,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,15JUL2017,15JUL2017,None,No,No,No,No,4,No,No
108-091,6001,1,Right axillary lymphadenopathy,23.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",18OCT2017,18OCT2017,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,07NOV2017,07NOV2017,None,No,No,No,No,8.2,No,No
108-091,6002,2,Night sweats,23.0,Skin and subcutaneous tissue disorders,Night sweats,Night sweats,Apocrine and eccrine gland disorders,Skin appendage conditions,19OCT2017,19OCT2017,Moderate,Moderate,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20OCT2017,20OCT2017,None,No,No,No,No,8.2,No,No
108-091,6003,3,Itchy at right injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,20OCT2017,20OCT2017,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22OCT2017,22OCT2017,None,No,No,No,No,8.4,No,No
108-323,6001,1,Viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,13JUN2017,13JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,17JUN2017,17JUN2017,Medication,No,No,No,No,2.1,No,No
108-064,6001,1,Vaginal pruritus,23.0,Reproductive system and breast disorders,Vulvovaginal pruritus,Vulvovaginal pruritus,Vulvovaginal signs and symptoms,Vulvovaginal disorders (excl infections and inflammations),04JUL2017,04JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JUL2017,06JUL2017,None,No,No,No,No,3,No,No
108-064,6002,2,Viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,12DEC2017,12DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15DEC2017,15DEC2017,Medication,No,No,No,No,10,No,No
108-052,6001,1,proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,23APR2018,23APR2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24APR2018,24APR2018,None,No,No,No,No,10,No,No
108-442,6001,1,URI - Sinus Congestion,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04DEC2017,04DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14DEC2017,14DEC2017,Medication,No,No,No,No,4.1,No,No
108-442,6002,2,Viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,19FEB2018,19FEB2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20FEB2018,20FEB2018,Medication,No,No,No,No,7,No,No
108-003,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,22JAN2018,22JAN2018,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,01FEB2018,01FEB2018,None,No,No,No,No,3,No,No
108-003,6002,2,"chlamydia, vaginal asymptomatic",23.0,Infections and infestations,Vaginitis chlamydial,Vaginitis chlamydial,Chlamydial infections,Chlamydial infectious disorders,28FEB2018,28FEB2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28MAR2018,28MAR2018,Medication,No,No,No,No,6,No,No
108-003,6003,3,Pruritis R injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,07JUL2018,07JUL2018,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09JUL2018,09JUL2018,None,No,No,No,No,8.1,No,No
108-327,6001,1,Viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,10APR2018,10APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21APR2018,21APR2018,Medication,No,No,No,No,6.1,No,No
108-478,6001,1,Pruritus Right deltoid at injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,14JAN2018,14JAN2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18JAN2018,18JAN2018,None,No,No,No,No,4.1,No,No
108-478,6002,2,right axillary lymph node tender mildly,23.0,Blood and lymphatic system disorders,Lymph node pain,Lymph node tenderness,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",11MAY2018,11MAY2018,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14MAY2018,14MAY2018,None,No,No,No,No,8.1,No,No
108-412,6001,1,proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,12DEC2017,12DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02JAN2018,02JAN2018,None,No,No,No,No,3,No,No
108-412,6002,2,hematuria,23.0,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,12DEC2017,12DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02JAN2018,02JAN2018,None,No,No,No,No,3,No,No
108-196,6001,1,ALT-Elevated,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,28NOV2017,28NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,12DEC2017,12DEC2017,None,No,No,No,No,3,No,No
108-196,6002,2,elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,16JAN2018,16JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05FEB2018,05FEB2018,None,No,No,No,No,5.1,No,No
108-196,6003,3,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,02MAY2018,02MAY2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22OCT2018,22OCT2018,None,No,No,No,No,10,No,No
108-123,6002,2,Dysphagia,23.0,Gastrointestinal disorders,Dysphagia,Dysphagia,Gastrointestinal signs and symptoms NEC,Gastrointestinal signs and symptoms,17JUL2018,17JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26JUL2018,26JUL2018,None,No,No,No,No,8.1,No,No
108-282,6001,1,Left maxillary sinus mass- mycetoma (fungal ball),23.0,Infections and infestations,Mycetoma mycotic,Mycetoma NOS,Fungal infections NEC,Fungal infectious disorders,07MAR2018,07MAR2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04MAY2018,04MAY2018,"Medication, Procedure/Surgery",No,No,No,No,8,No,No
108-368,6001,1,chlamydia genitourinary symptomatic,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,19SEP2018,19SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,19SEP2018,19SEP2018,Medication,No,No,No,No,11,No,No
108-489,6001,1,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,25JAN2018,25JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JAN2018,30JAN2018,Medication,No,No,No,No,3,No,No
108-142,6001,1,Lymph node 1cm painful inflamed,23.0,Blood and lymphatic system disorders,Lymph node pain,Lymph node pain,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",12APR2018,12APR2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,15APR2018,15APR2018,None,No,No,No,No,6.1,No,No
108-142,6002,2,Right axilla pain,23.0,General disorders and administration site conditions,Axillary pain,Axillary pain,Pain and discomfort NEC,General system disorders NEC,12JUL2018,12JUL2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,13JUL2018,13JUL2018,None,No,No,No,No,8.1,No,No
108-009,6001,1,rectal bleeding,23.0,Gastrointestinal disorders,Rectal haemorrhage,Rectal bleeding,Intestinal haemorrhages,Gastrointestinal haemorrhages NEC,01MAR2018,01MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02MAR2018,02MAR2018,None,No,No,No,No,2.1,No,No
108-009,6002,2,head trauma,23.0,"Injury, poisoning and procedural complications",Head injury,Head injury,Site specific injuries NEC,Injuries NEC,20MAR2018,20MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20MAR2018,20MAR2018,None,No,No,No,No,4,No,No
108-009,6003,3,grade 2 increase creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,12APR2018,12APR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,29MAY2018,29MAY2018,None,No,No,No,No,5,No,No
108-009,6004,4,grade 2 increase creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,08JUN2018,08JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16AUG2018,16AUG2018,None,No,No,No,No,7,No,No
108-009,6006,6,grade 2 increse creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,05SEP2018,05SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21DEC2018,21DEC2018,None,No,No,No,No,10,No,No
108-461,6001,1,gastroenteritis,23.0,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,09MAR2018,09MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13MAR2018,13MAR2018,None,No,No,No,No,4.1,No,No
108-100,6001,1,grade 2 increase creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,05MAR2018,05MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,05APR2018,05APR2018,None,No,No,No,No,3,No,No
108-055,6001,1,vertigo,23.0,Ear and labyrinth disorders,Vertigo,Vertigo,Inner ear signs and symptoms,Inner ear and VIIIth cranial nerve disorders,11JUN2018,11JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,12JUN2018,12JUN2018,None,No,No,No,No,6,No,No
108-014,6001,1,Ocular pruritus L eye,23.0,Eye disorders,Eye pruritus,Eye pruritus,"Ocular infections, inflammations and associated manifestations","Ocular infections, irritations and inflammations",24JUN2018,24JUN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUN2018,25JUN2018,None,No,No,No,No,4.1,No,No
108-392,6001,1,injection site pruritus,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,15JUL2018,15JUL2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,16JUL2018,16JUL2018,None,No,No,No,No,4.1,No,No
108-392,6002,2,pruritus right injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,10NOV2018,10NOV2018,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14NOV2018,14NOV2018,None,No,No,No,No,8.1,No,No
108-302,6002,2,Pruritis R injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,18JUL2018,18JUL2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20JUL2018,20JUL2018,None,No,No,No,No,4.1,No,No
108-302,6003,3,L chest wall contusion,23.0,"Injury, poisoning and procedural complications",Contusion,Contusion of chest wall,Skin injuries NEC,Injuries NEC,14AUG2018,14AUG2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,21AUG2018,21AUG2018,Medication,No,No,No,No,6,No,No
108-302,6004,4,superficial needle scratch,23.0,"Injury, poisoning and procedural complications",Scratch,Scratch,Skin injuries NEC,Injuries NEC,13NOV2018,13NOV2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19NOV2018,19NOV2018,Other,No,No,No,No,8,No,No
108-274,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,09SEP2017,09SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14SEP2017,14SEP2017,Medication,No,No,No,No,8,No,No
108-274,6002,2,Testicular Pain,23.0,Reproductive system and breast disorders,Testicular pain,Testicular pain,Testicular and epididymal disorders NEC,Testicular and epididymal disorders,12SEP2017,12SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14SEP2017,14SEP2017,Medication,No,No,No,No,8.1,No,No
108-158,6001,1,ALT Elevation,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,08MAY2017,08MAY2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,02JUN2017,02JUN2017,None,No,No,No,No,3,No,No
108-158,6002,2,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,03NOV2017,03NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15NOV2017,15NOV2017,Medication,No,No,No,No,10,No,No
108-158,6003,3,ALT elevation,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,07NOV2017,07NOV2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,03MAY2018,03MAY2018,None,No,No,No,No,10,No,No
108-450,6001,1,Bacterial Vaginosis,23.0,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,10JUL2017,10JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26DEC2017,26DEC2017,Other,No,No,No,No,4,No,No
108-450,6002,2,"Depression, Aggravated",23.0,Psychiatric disorders,Depression,Depression aggravated,Depressive disorders,Depressed mood disorders and disturbances,AUG2017,15AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,8,No,No
108-309,6003,3,Fracture of 5th metatarsal of left foot,23.0,"Injury, poisoning and procedural complications",Foot fracture,Fractured metatarsal,Limb fractures and dislocations,Bone and joint injuries,12NOV2017,12NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07DEC2017,07DEC2017,Medication,No,No,No,No,8,No,No
108-495,6001,1,Tender Left Lateral Malleolus,23.0,Musculoskeletal and connective tissue disorders,Arthralgia,Pain in ankle,Joint related signs and symptoms,Joint disorders,12AUG2017,12AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,22AUG2017,22AUG2017,Medication,No,No,No,No,4,No,No
108-495,6002,2,Elevated creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,29JAN2018,29JAN2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01FEB2018,01FEB2018,None,No,No,No,No,10,No,No
108-148,6001,1,Community-Acquired URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04DEC2017,04DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,18DEC2017,18DEC2017,Medication,No,No,No,No,4,No,No
108-178,6001,1,"Ganglion Cyst, R wrist",23.0,Musculoskeletal and connective tissue disorders,Synovial cyst,Ganglion cyst,Synovial disorders,Synovial and bursal disorders,DEC2017,15DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,31JAN2018,31JAN2018,Procedure/Surgery,No,No,No,No,7,No,No
108-513,6001,1,"SEBHORRHEIC DERMATITIS, RIGHT EAR",23.0,Skin and subcutaneous tissue disorders,Seborrhoeic dermatitis,Seborrheic dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,23MAR2018,23MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUN2018,07JUN2018,Medication,No,No,No,No,8,No,No
108-247,6001,1,Left Knee Injury (r/t fall),23.0,"Injury, poisoning and procedural complications",Joint injury,Knee injury,Bone and joint injuries NEC,Bone and joint injuries,02FEB2018,02FEB2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14FEB2018,14FEB2018,None,No,No,No,No,6,No,No
108-247,6002,2,"Xerosis, B/L upper extremities",23.0,Skin and subcutaneous tissue disorders,Dry skin,Skin xerosis,Dermal and epidermal conditions NEC,Epidermal and dermal conditions,15JAN2018,15JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01JUN2018,01JUN2018,None,No,No,No,No,7,No,No
108-436,6001,1,Community-Acquired URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26NOV2017,26NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03DEC2017,03DEC2017,Medication,No,No,No,No,4,No,No
108-436,6002,2,Conjunctivitis,23.0,Infections and infestations,Conjunctivitis,Conjunctivitis,Eye and eyelid infections,Infections - pathogen unspecified,08DEC2017,08DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16JAN2018,16JAN2018,Medication,No,No,No,No,5,No,No
108-249,6001,1,Tonsillitis,23.0,Infections and infestations,Tonsillitis,Tonsillitis,Upper respiratory tract infections,Infections - pathogen unspecified,08JAN2018,08JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12JAN2018,12JAN2018,Medication,No,No,No,No,7,No,No
108-234,6001,1,"Dermatitis, B/L forearm",23.0,Skin and subcutaneous tissue disorders,Dermatitis,Dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,24JAN2018,24JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,23AUG2018,23AUG2018,None,No,No,No,No,6,No,No
108-234,6002,2,"CHLAMYDIA, UROGENITAL, SYMPTOMATIC",23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,15MAY2018,15MAY2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20MAY2018,20MAY2018,Medication,No,No,No,No,10,No,No
108-234,6003,3,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,17MAY2018,17MAY2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06SEP2018,06SEP2018,None,No,No,No,No,10,No,No
108-059,6001,1,Upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,29DEC2017,29DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08JAN2018,08JAN2018,None,No,No,No,No,3,No,No
108-059,6002,2,Vaginal Yeast Infection,23.0,Infections and infestations,Vulvovaginal mycotic infection,Vaginal yeast infection,Fungal infections NEC,Fungal infectious disorders,08MAR2018,08MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAR2018,15MAR2018,Medication,No,No,No,No,8,No,No
108-059,6003,3,Sprained right ankle,23.0,"Injury, poisoning and procedural complications",Ligament sprain,Sprained ankle,"Muscle, tendon and ligament injuries",Injuries NEC,27NOV2018,27NOV2018,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,12,No,No
108-499,6001,1,"LYMPHADENOPATHY, CERVICAL, RIGHT-SIDED",23.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy cervical,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",15DEC2017,15DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16DEC2017,16DEC2017,None,No,No,No,No,3,No,No
108-520,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,03JAN2018,03JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16JAN2018,16JAN2018,None,No,No,No,No,3,No,No
108-297,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27DEC2017,27DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12JAN2018,12JAN2018,Medication,No,No,No,No,4,No,No
108-297,6002,2,Stye of left lower eye lid,23.0,Infections and infestations,Hordeolum,Stye,Eye and eyelid infections,Infections - pathogen unspecified,11DEC2017,11DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18DEC2017,18DEC2017,None,No,No,No,No,6,No,No
108-297,6003,3,Internal hordeolum of left lower eye lid,23.0,Infections and infestations,Hordeolum,Internal hordeolum,Eye and eyelid infections,Infections - pathogen unspecified,22JAN2018,22JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,08MAR2018,08MAR2018,Medication,No,No,No,No,6,No,No
108-297,6004,4,asymptomatic rectal chlamydia,23.0,Infections and infestations,Proctitis chlamydial,Proctitis chlamydial,Chlamydial infections,Chlamydial infectious disorders,24SEP2018,24SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24SEP2018,24SEP2018,Medication,No,No,No,No,12,No,No
108-297,6005,5,Asymptomatic Rectal Chlamydia,23.0,Infections and infestations,Proctitis chlamydial,Proctitis chlamydial,Chlamydial infections,Chlamydial infectious disorders,31DEC2018,31DEC2018,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,12,No,No
108-338,6001,1,"hematuria, asymptomatic",23.0,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,29JAN2018,29JAN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12FEB2018,12FEB2018,None,No,No,No,No,3,No,No
108-190,6001,1,Left Mild Ulnar Neuropathy,23.0,Nervous system disorders,Neuropathy peripheral,Neuropathy,Peripheral neuropathies NEC,Peripheral neuropathies,16JUN2018,16JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUL2018,07JUL2018,Medication,No,No,No,No,8,No,No
108-190,6002,2,Molluscum of left forearm,23.0,Infections and infestations,Molluscum contagiosum,Molluscum contagiosum,Molluscum contagiosum viral infections,Viral infectious disorders,01JUL2018,01JUL2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01SEP2018,01SEP2018,Medication,No,No,No,No,8,No,No
108-190,6003,3,Elevated serum bilirubin,23.0,Investigations,Blood bilirubin increased,Serum bilirubin increased,Liver function analyses,Hepatobiliary investigations,16JUL2018,16JUL2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Severity/Frequency,Severity/Frequency,16OCT2018,16OCT2018,None,No,No,No,No,10,No,No
108-190,6004,4,Elevated Serum Bilirubin,23.0,Investigations,Blood bilirubin increased,Serum bilirubin increased,Liver function analyses,Hepatobiliary investigations,16OCT2018,16OCT2018,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,11,No,No
108-222,6001,1,R thigh contusion r/t mechanical trauma,23.0,"Injury, poisoning and procedural complications",Contusion,Contusion of thigh,Skin injuries NEC,Injuries NEC,18FEB2018,18FEB2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAR2018,01MAR2018,None,No,No,No,No,3,No,No
108-222,6002,2,Eczema Aggravation,23.0,Skin and subcutaneous tissue disorders,Eczema,Eczema aggravated,Dermatitis and eczema,Epidermal and dermal conditions,13FEB2018,13FEB2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,23MAR2018,23MAR2018,Medication,No,No,No,No,3,No,No
108-222,6003,3,Miliaria,23.0,Skin and subcutaneous tissue disorders,Miliaria,Miliaria,Apocrine and eccrine gland disorders,Skin appendage conditions,29JUL2018,29JUL2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26AUG2018,26AUG2018,None,No,No,No,No,10,No,No
108-215,6001,1,penile laceration secondary to dog bite,23.0,"Injury, poisoning and procedural complications",Animal bite,Dog bite,Non-site specific injuries NEC,Injuries NEC,06MAY2017,06MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,10MAY2017,10MAY2017,Medication,No,No,No,No,2,No,No
108-215,6002,2,hangover,23.0,General disorders and administration site conditions,Hangover,Hangover,Feelings and sensations NEC,General system disorders NEC,20JUL2017,20JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,20JUL2017,20JUL2017,Medication,No,No,No,No,6,No,No
108-335,6001,1,diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,15JUL2017,15JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20OCT2017,20OCT2017,None,No,No,No,No,8,No,No
108-491,6001,1,sebaceous cysts - axilla bilateral,23.0,Skin and subcutaneous tissue disorders,Dermal cyst,Sebaceous cyst,Skin cysts and polyps,Cutaneous neoplasms benign,06AUG2017,06AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30AUG2017,30AUG2017,None,No,No,No,No,6,No,No
108-236,6001,1,elevated blood preasure,23.0,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),25OCT2017,25OCT2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30JAN2018,30JAN2018,None,No,No,No,No,7,No,No
108-236,6002,2,depression,23.0,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,15APR2018,15APR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,12,No,No
108-511,6001,1,diarrhea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,05JUN2018,05JUN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12JUN2018,12JUN2018,Medication,No,No,No,No,12,No,No
108-511,6002,2,Viral Illness,23.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,13OCT2017,13OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15OCT2017,15OCT2017,Medication,No,No,No,No,6,No,No
108-121,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,09MAR2018,09MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17MAR2018,17MAR2018,None,No,No,No,No,5,No,No
108-391,6001,1,Yeast Infection,23.0,Infections and infestations,Fungal infection,Yeast infection,Fungal infections NEC,Fungal infectious disorders,JUN2018,15JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,JUN2018,15JUN2018,Medication,No,No,No,No,8,No,No
108-387,6002,2,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20MAR2018,20MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26MAR2018,26MAR2018,Medication,No,No,No,No,4,No,No
108-387,6003,3,Pruritis,23.0,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,22AUG2018,22AUG2018,Moderate,Moderate,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,25AUG2018,25AUG2018,None,No,No,No,No,8,No,No
108-010,6001,1,Sinus discomfort,23.0,"Respiratory, thoracic and mediastinal disorders",Sinus pain,Sinus pain,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,05MAR2018,05MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,06MAR2018,06MAR2018,None,No,No,No,No,3,No,No
108-186,6001,1,proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,21AUG2018,21AUG2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06SEP2018,06SEP2018,None,No,No,No,No,8,No,No
108-042,6001,1,elevated Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,09MAR2018,09MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,21MAR2018,21MAR2018,None,No,No,No,No,2.1,No,No
108-143,6001,1,elevated ALT (63),23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,03APR2018,03APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17APR2018,17APR2018,None,No,No,No,No,3,No,No
108-143,6002,2,tooth infection,23.0,Infections and infestations,Tooth infection,Tooth infection,Dental and oral soft tissue infections,Infections - pathogen unspecified,22APR2018,22APR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAY2018,01MAY2018,Medication,No,No,No,No,5,No,No
108-143,6003,3,elevated creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,10SEP2018,10SEP2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20NOV2018,20NOV2018,None,No,No,No,No,10,No,No
108-365,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20MAY2018,20MAY2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,25MAY2018,25MAY2018,Medication,No,No,No,No,5,No,No
108-365,6002,2,macular rash (b/l forearms),23.0,Skin and subcutaneous tissue disorders,Rash macular,Macular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,04JUL2018,04JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01AUG2018,01AUG2018,None,No,No,No,No,7,No,No
108-515,6001,1,ectopic pregnancy,23.0,"Pregnancy, puerperium and perinatal conditions",Ectopic pregnancy,Ectopic pregnancy,Maternal complications of pregnancy NEC,Maternal complications of pregnancy,15OCT2018,15OCT2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,18OCT2018,18OCT2018,Medication,No,No,No,No,8,No,No
108-057,6001,1,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,14JUN2018,14JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUL2018,07JUL2018,Medication,No,No,No,No,4,No,No
108-057,6002,2,strained hamstring,23.0,"Injury, poisoning and procedural complications",Muscle strain,Pulled hamstring,"Muscle, tendon and ligament injuries",Injuries NEC,07JUL2018,07JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01SEP2018,01SEP2018,Medication,No,No,No,No,5,No,No
108-057,6003,3,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,11JUL2018,11JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21AUG2018,21AUG2018,None,No,No,No,No,5,No,No
108-057,6004,4,Elevated AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,11JUL2018,11JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21AUG2018,21AUG2018,None,No,No,No,No,5,No,No
108-360,6002,2,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04SEP2018,04SEP2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12SEP2018,12SEP2018,Medication,No,No,No,No,6,No,No
108-464,6001,1,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,28SEP2018,28SEP2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,04OCT2018,04OCT2018,Medication,No,No,No,No,7,No,No
108-104,6001,1,URI,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18DEC2018,18DEC2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28DEC2018,28DEC2018,None,No,No,No,No,8,No,No
108-453,6001,1,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08DEC2018,08DEC2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16DEC2018,16DEC2018,Medication,No,No,No,No,8,No,No
108-455,6001,1,Pharyngitis,23.0,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,26JUL2018,26JUL2018,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,30JUL2018,30JUL2018,None,No,No,No,No,2,No,No
108-455,6002,2,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,13AUG2018,13AUG2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15AUG2018,15AUG2018,None,No,No,No,No,4,No,No
108-455,6004,4,Strep Throat,23.0,Infections and infestations,Pharyngitis streptococcal,Streptococcal sore throat,Streptococcal infections,Bacterial infectious disorders,19JAN2019,19JAN2019,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,25JAN2019,25JAN2019,Medication,No,No,No,No,10,No,No
108-455,6005,5,Polycystic ovarian syndrome,23.0,Reproductive system and breast disorders,Polycystic ovaries,Polycystic ovarian syndrome,Ovarian and fallopian tube cysts and neoplasms,Ovarian and fallopian tube disorders,15MAR2019,15MAR2019,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,11,No,No
108-341,6001,1,Bilary Acute Pancreatitis Without Necrosis or Infection,23.0,Gastrointestinal disorders,Pancreatitis acute,Acute pancreatitis,Acute and chronic pancreatitis,Exocrine pancreas conditions,03MAY2019,03MAY2019,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,08MAY2019,08MAY2019,"Medication, New/Prolonged Hospitalization",Yes,Yes,Yes,Yes,11,No,No
108-341,6002,2,Acute Gallstone Pancreatitis,23.0,Gastrointestinal disorders,Obstructive pancreatitis,Pancreatitis due to gallstones,Acute and chronic pancreatitis,Exocrine pancreas conditions,17APR2019,17APR2019,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20APR2019,20APR2019,Procedure/Surgery,Yes,Yes,Yes,Yes,11,No,No
108-136,6001,1,headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,06NOV2017,06NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10NOV2017,10NOV2017,Medication,No,No,No,No,8,No,No
108-523,6001,1,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,07SEP2017,07SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14NOV2017,14NOV2017,None,No,No,No,No,7,No,No
108-120,6001,1,upper respiratory infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10NOV2017,10NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17NOV2017,17NOV2017,None,No,No,No,No,6,No,No
108-073,6001,1,pharyngitis,23.0,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,04FEB2018,04FEB2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13FEB2018,13FEB2018,Medication,No,No,No,No,8,No,No
108-233,6002,2,viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,05MAR2018,05MAR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,23MAR2018,23MAR2018,None,No,No,No,No,8,No,No
108-200,6001,1,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,29JAN2018,29JAN2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,27MAR2018,27MAR2018,None,No,No,No,No,5,No,No
108-200,6002,2,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,14JUN2018,14JUN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30NOV2018,30NOV2018,None,No,No,No,No,10,No,No
108-175,6001,1,viral syndrome,23.0,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,05APR2018,05APR2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,12APR2018,12APR2018,Medication,No,No,No,No,6,No,No
108-023,6001,1,ADHD,23.0,Psychiatric disorders,Attention deficit hyperactivity disorder,ADHD,Attention deficit and disruptive behaviour disorders,Cognitive and attention disorders and disturbances,02MAY2018,02MAY2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16DEC2018,16DEC2018,Medication,No,No,No,No,6,No,No
108-206,6001,1,INCISED WOUND ALONG LEFT JAWLINE.,23.0,"Injury, poisoning and procedural complications",Wound,Incised wound,Non-site specific injuries NEC,Injuries NEC,12APR2018,12APR2018,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,29MAY2018,29MAY2018,Procedure/Surgery,No,No,No,No,5,No,No
108-043,6001,1,Pruritis without Rash,23.0,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,08MAY2018,08MAY2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10MAY2018,10MAY2018,None,No,No,No,No,5,No,No
108-043,6002,2,Low Hemoglobin,23.0,Investigations,Haemoglobin decreased,Hemoglobin low,Red blood cell analyses,Haematology investigations (incl blood groups),23JUL2018,23JUL2018,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,27SEP2018,27SEP2018,None,No,No,No,No,7,No,No
108-043,6003,3,Elevated creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,23JUL2018,23JUL2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,27SEP2018,27SEP2018,None,No,No,No,No,7,No,No
108-456,6001,1,Upper Respiratory Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08MAY2018,08MAY2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12MAY2018,12MAY2018,Medication,No,No,No,No,5,No,No
108-245,6001,1,Elevated Creatnine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,12JUN2018,12JUN2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,23JUL2018,23JUL2018,None,No,No,No,No,5.1,No,No
108-097,6001,1,viral rhinitis,23.0,Infections and infestations,Viral rhinitis,Viral rhinitis,Viral infections NEC,Viral infectious disorders,12FEB2017,12FEB2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15FEB2017,15FEB2017,Medication,No,No,No,No,3,No,No
108-097,6003,3,Male Urethritis Syndrome,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,24JUL2017,24JUL2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12SEP2017,12SEP2017,Medication,No,No,No,No,10.1,No,No
108-398,6001,1,Allergic dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis allergic,Allergic dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,13FEB2017,13FEB2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07MAR2017,07MAR2017,Medication,No,No,No,No,3.1,No,No
108-398,6002,2,Upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,04MAR2017,04MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11MAR2017,11MAR2017,None,No,No,No,No,4,No,No
108-398,6003,3,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,14FEB2017,14FEB2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22MAR2017,22MAR2017,Other,No,No,No,No,3,No,No
108-398,6004,4,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,03MAY2017,03MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JUL2017,06JUL2017,None,No,No,No,No,7,No,No
108-046,6002,2,Asymptomatic genitourinary Chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,08AUG2017,08AUG2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,31AUG2017,31AUG2017,Medication,No,No,No,No,10,No,No
108-208,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,30MAY2017,30MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,04JUN2017,04JUN2017,Medication,No,No,No,No,7.1,No,No
108-242,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,06JUL2017,06JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14JUL2017,14JUL2017,Medication,No,No,No,No,8,No,No
108-242,6002,2,Genital Herpes,23.0,Infections and infestations,Genital herpes,Genital herpes,Herpes viral infections,Viral infectious disorders,15AUG2017,15AUG2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12OCT2017,12OCT2017,Medication,No,No,No,No,10.1,No,No
108-470,6001,1,Male Urethritis Syndrome,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,16MAR2017,16MAR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,17MAR2017,17MAR2017,Medication,No,No,No,No,5,No,No
108-470,6002,2,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,28JUL2017,28JUL2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04AUG2017,04AUG2017,Medication,No,No,No,No,10,No,No
108-470,6003,3,Gum Infection,23.0,Infections and infestations,Gingivitis,Gum infection,Dental and oral soft tissue infections,Infections - pathogen unspecified,09AUG2017,09AUG2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20AUG2017,20AUG2017,"Medication, Other",No,No,No,No,10.1,No,No
108-108,6001,1,elevated alt,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,23MAY2017,23MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30MAY2017,30MAY2017,Other,No,No,No,No,7,No,No
108-108,6002,2,elevated ast,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,23MAY2017,23MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30MAY2017,30MAY2017,Other,No,No,No,No,7,No,No
108-187,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,18JUL2017,18JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,27JUL2017,27JUL2017,Medication,No,No,No,No,7.1,No,No
108-187,6002,2,Elevated Blood Pressure,23.0,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),19JUL2017,19JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUL2017,25JUL2017,None,No,No,No,No,7.1,No,No
108-408,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,02SEP2017,02SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,07SEP2017,07SEP2017,Medication,No,No,No,No,10.1,No,No
108-299,6001,1,Elevated AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,25APR2017,25APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01JUN2017,01JUN2017,None,No,No,No,No,5,No,No
108-068,6001,1,Epistaxis,23.0,"Respiratory, thoracic and mediastinal disorders",Epistaxis,Epistaxis,Nasal disorders NEC,Upper respiratory tract disorders (excl infections),25MAR2017,25MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25MAR2017,25MAR2017,None,No,No,No,No,4,No,No
108-068,6002,2,Scabies rash both hands,23.0,Infections and infestations,Acarodermatitis,Scabies,Ectoparasitic infestations,Ectoparasitic disorders,APR2017,15APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16APR2017,16APR2017,"Medication, Other",No,No,No,No,5,No,No
108-068,6003,3,(Asymptomatic) Genitourinary chalmydia trachomatis,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,28FEB2018,28FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,"Medication, Other",No,No,No,No,12,No,No
108-257,6001,1,Lower left pleuritic pain,23.0,"Respiratory, thoracic and mediastinal disorders",Pleuritic pain,Pleuritic pain,Lower respiratory tract signs and symptoms,Respiratory tract signs and symptoms,MAR2017,15MAR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10MAY2017,10MAY2017,Other,No,No,No,No,5,No,No
108-257,6002,2,PROTEINURIA,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,31AUG2017,31AUG2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28FEB2018,28FEB2018,None,No,No,No,No,10,No,No
108-156,6001,1,(Asymptomatic) Genitourinary Chlamydia Trachomatis,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,31AUG2017,31AUG2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06SEP2017,06SEP2017,Medication,No,No,No,No,10,No,No
108-156,6002,2,SEXUALLY TRANSMITTED INFECTION,23.0,Infections and infestations,Sexually transmitted disease,Sexually transmitted infection,Infectious transmissions,Ancillary infectious topics,04FEB2018,04FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,10FEB2018,10FEB2018,Medication,No,No,No,No,11.1,No,No
108-452,6001,1,Raised creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,23MAR2017,23MAR2017,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,04APR2017,04APR2017,Other,No,No,No,No,3,No,No
108-452,6002,2,Itching at injection site,23.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,19APR2017,19APR2017,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20APR2017,20APR2017,None,No,No,No,No,4.1,No,No
108-376,6001,1,Flu-like illness,23.0,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,24APR2017,24APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20MAY2017,20MAY2017,Medication,No,No,No,No,5,No,No
108-238,6001,1,Upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,22JUN2017,22JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUN2017,30JUN2017,"Medication, Other",No,No,No,No,7.1,No,No
108-238,6002,2,SEXUALLY TRANSMITTED INFECTION,23.0,Infections and infestations,Sexually transmitted disease,Sexually transmitted infection,Infectious transmissions,Ancillary infectious topics,07FEB2018,07FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11FEB2018,11FEB2018,Medication,No,No,No,No,11.1,No,No
108-484,6001,1,Bilateral foot pain,23.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Foot pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,03MAY2017,03MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08MAY2017,08MAY2017,Medication,No,No,No,No,5,No,No
108-484,6002,2,upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,22JUN2017,22JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25JUN2017,25JUN2017,None,No,No,No,No,6,No,No
108-240,6001,1,Hypertension,23.0,Vascular disorders,Hypertension,Hypertension,Vascular hypertensive disorders NEC,Vascular hypertensive disorders,04MAY2017,04MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,"Medication, Other",No,No,No,No,4,No,No
108-161,6001,1,Flu-like illness,23.0,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,16MAR2017,16MAR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,20MAR2017,20MAR2017,Medication,No,No,No,No,3,No,No
108-161,6002,2,(Asymptomatic) GENITOURINARY CHLAMYDIA TRACHOMATIS,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,09MAR2018,09MAR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27MAR2018,27MAR2018,"Medication, Other",No,No,No,No,12,No,No
108-171,6001,1,Herpetic lesion on Penis,23.0,Infections and infestations,Genital herpes,Genital herpes,Herpes viral infections,Viral infectious disorders,02APR2017,02APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10APR2017,10APR2017,None,No,No,No,No,3,No,No
108-171,6002,2,Folliculitis anteria neck and left axilla,23.0,Infections and infestations,Folliculitis,Folliculitis,Skin structures and soft tissue infections,Infections - pathogen unspecified,12APR2017,12APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21APR2017,21APR2017,"Medication, Other",No,No,No,No,3.1,No,No
108-171,6003,3,Itching around right elbow,23.0,Skin and subcutaneous tissue disorders,Pruritus,Localized itching,Pruritus NEC,Epidermal and dermal conditions,23APR2017,23APR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,25APR2017,25APR2017,Medication,No,No,No,No,5,No,No
108-171,6004,4,Urinary tract infection,23.0,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,10MAY2017,10MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13MAY2017,13MAY2017,"Medication, Other",No,No,No,No,5.1,No,No
108-171,6005,5,Sexually transmitted infection,23.0,Infections and infestations,Sexually transmitted disease,Sexually transmitted infection,Infectious transmissions,Ancillary infectious topics,25JUN2017,25JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28JUN2017,28JUN2017,Medication,No,No,No,No,6.1,No,No
108-383,6001,1,Upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,01MAY2017,01MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06MAY2017,06MAY2017,None,No,No,No,No,4,No,No
108-330,6001,1,Papular rash on back and arms caused by insect bites,23.0,"Injury, poisoning and procedural complications",Arthropod bite,Insect bite NOS,Non-site specific injuries NEC,Injuries NEC,05APR2017,05APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18APR2017,18APR2017,"Medication, Other",No,No,No,No,3.1,No,No
108-330,6002,2,Musculoskeletal chest pain-lower right,23.0,Musculoskeletal and connective tissue disorders,Musculoskeletal chest pain,Musculoskeletal chest pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,10APR2017,10APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13APR2017,13APR2017,"Medication, Other",No,No,No,No,3.1,No,No
108-330,6003,3,Raised AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,04MAY2017,04MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08JUN2017,08JUN2017,None,No,No,No,No,5,No,No
108-276,6001,1,Gastritis,23.0,Gastrointestinal disorders,Gastritis,Gastritis,Gastritis (excl infective),Gastrointestinal inflammatory conditions,29APR2017,29APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07MAY2017,07MAY2017,Medication,No,No,No,No,4,No,No
108-276,6002,2,Allergic Rhinitis,23.0,"Respiratory, thoracic and mediastinal disorders",Rhinitis allergic,Allergic rhinitis,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),22JUL2017,22JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,04AUG2017,04AUG2017,Other,No,No,No,No,7.1,No,No
108-276,6003,3,Bacterial Tonsilitis,23.0,Infections and infestations,Tonsillitis bacterial,Tonsillitis bacterial,Bacterial infections NEC,Bacterial infectious disorders,22JUL2017,22JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,27JUL2017,27JUL2017,Medication,No,No,No,No,7.1,No,No
108-276,6005,5,Urinary Tract Infection,23.0,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,05OCT2017,05OCT2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,18OCT2017,18OCT2017,None,No,No,No,No,10,No,No
108-337,6001,1,Diarrhoea,23.0,Gastrointestinal disorders,Diarrhoea,Diarrhoea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,10MAY2017,10MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14MAY2017,14MAY2017,"Medication, Other",No,No,No,No,4.1,No,No
108-230,6001,1,Raised AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,17JUL2017,17JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,27SEP2017,27SEP2017,None,No,No,No,No,7,No,No
108-070,6001,1,Urinary tract infection,23.0,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,12APR2017,12APR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15SEP2017,15SEP2017,Medication,No,No,No,No,3,No,No
108-070,6002,2,Pityriasis Versicolor,23.0,Infections and infestations,Tinea versicolour,Pityriasis versicolor,Tinea infections,Fungal infectious disorders,06MAY2017,06MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,02JUN2017,02JUN2017,Medication,No,No,No,No,5.1,No,No
108-070,6004,4,Raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,10JUL2017,10JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31JUL2017,31JUL2017,None,No,No,No,No,7,No,No
108-070,6005,5,Allergic Dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis allergic,Allergic dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,17SEP2017,17SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,MAR2018,15MAR2018,Medication,No,No,No,No,10.1,No,No
108-070,6006,6,Raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,29SEP2017,29SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Severity/Frequency,Severity/Frequency,17NOV2017,17NOV2017,None,No,No,No,No,10,No,No
108-070,6007,7,RAISED AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,29SEP2017,29SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Severity/Frequency,Severity/Frequency,17NOV2017,17NOV2017,None,No,No,No,No,10,No,No
108-070,6008,8,Raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,17NOV2017,17NOV2017,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,07FEB2018,07FEB2018,None,No,No,No,No,10.2,No,No
108-070,6009,9,Raised AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,17NOV2017,17NOV2017,Potentially life-threatening,Potentially life-threatening,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,08JAN2018,08JAN2018,None,No,No,No,No,10.2,No,No
108-509,6001,1,Athralgia left wrist and elbow,23.0,Musculoskeletal and connective tissue disorders,Arthralgia,Arthralgia,Joint related signs and symptoms,Joint disorders,26APR2017,26APR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAY2017,01MAY2017,"Medication, Other",No,No,No,No,2.1,No,No
108-509,6002,2,Acute sinusitis,23.0,Infections and infestations,Acute sinusitis,Acute sinusitis,Upper respiratory tract infections,Infections - pathogen unspecified,24MAY2017,24MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,31MAY2017,31MAY2017,Medication,No,No,No,No,4.1,No,No
108-509,6003,3,Facial bone fracture,23.0,"Injury, poisoning and procedural complications",Facial bones fracture,Facial bones fracture,"Skull fractures, facial bone fractures and dislocations",Bone and joint injuries,16JUN2017,16JUN2017,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,23JUL2017,23JUL2017,New/Prolonged Hospitalization,Yes,Yes,Yes,Yes,5.1,No,No
108-509,6005,5,lower respiratory tract infection,23.0,Infections and infestations,Lower respiratory tract infection,Lower respiratory tract infection,Lower respiratory tract and lung infections,Infections - pathogen unspecified,19JAN2018,19JAN2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26JAN2018,26JAN2018,"Medication, New/Prolonged Hospitalization",Yes,Yes,Yes,Yes,11.1,No,No
108-509,6006,6,Male urethritis syndrome,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,25NOV2017,25NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,DEC2017,15DEC2017,Medication,No,No,No,No,10.1,No,No
108-509,6007,7,Urethritis,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,19APR2018,19APR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20APR2018,20APR2018,Medication,No,No,No,No,12.1,No,No
108-509,6008,8,Urethritis,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,28APR2018,28APR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,Medication,No,No,No,No,12.2,No,No
108-174,6001,1,temporal headache,23.0,Nervous system disorders,Headache,Temporal headache,Headaches NEC,Headaches,08APR2017,08APR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,13APR2017,13APR2017,Medication,No,No,No,No,3,No,No
108-174,6002,2,raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,17MAY2017,17MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,23JUN2017,23JUN2017,None,No,No,No,No,5,No,No
108-174,6003,3,upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,27SEP2017,27SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01OCT2017,01OCT2017,Medication,No,No,No,No,10,No,No
108-174,6004,4,raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,29SEP2017,29SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09NOV2017,09NOV2017,None,No,No,No,No,10,No,No
108-229,6001,1,proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,20NOV2017,20NOV2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11JAN2018,11JAN2018,None,No,No,No,No,10,No,No
108-229,6002,2,increase creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,20NOV2017,20NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26FEB2018,26FEB2018,None,No,No,No,No,10,No,No
108-358,6001,1,perianal furuncle,23.0,Infections and infestations,Furuncle,Furuncle,Staphylococcal infections,Bacterial infectious disorders,23APR2017,23APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18MAY2017,18MAY2017,Medication,No,No,No,No,4,No,No
108-389,6001,1,upper respiratory tract infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,17AUG2017,17AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,19AUG2017,19AUG2017,Medication,No,No,No,No,7,No,No
108-415,6001,1,laceration left index finger,23.0,"Injury, poisoning and procedural complications",Skin laceration,Laceration of finger,Skin injuries NEC,Injuries NEC,13JUN2017,13JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,JUL2017,15JUL2017,Medication,No,No,No,No,4,No,No
108-067,6001,1,raised ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,19JUN2017,19JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03JUL2017,03JUL2017,None,No,No,No,No,3,No,No
108-067,6002,2,raised AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,19JUN2017,19JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03JUL2017,03JUL2017,None,No,No,No,No,3,No,No
108-306,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,20DEC2017,20DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29MAR2018,29MAR2018,None,No,No,No,No,10,No,No
108-324,6001,1,Raised AST,23.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,21JUN2017,21JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05JUL2017,05JUL2017,None,No,No,No,No,3,No,No
108-416,6001,1,Increased creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,12DEC2017,12DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28MAR2018,28MAR2018,None,No,No,No,No,10,No,No
108-440,6001,1,Acute tonsillitis,23.0,Infections and infestations,Tonsillitis,Acute tonsillitis,Upper respiratory tract infections,Infections - pathogen unspecified,10APR2017,10APR2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14APR2017,14APR2017,Medication,No,No,No,No,3,No,No
108-440,6002,2,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,12APR2017,12APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JUN2017,06JUN2017,None,No,No,No,No,3,No,No
108-440,6003,3,Increased ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,12APR2017,12APR2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26APR2017,26APR2017,None,No,No,No,No,3,No,No
108-440,6004,4,Contact dermatitis-bilateral hands,23.0,Skin and subcutaneous tissue disorders,Dermatitis contact,Contact dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,28JUN2017,28JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04JUL2017,04JUL2017,Medication,No,No,No,No,7,No,No
108-373,6001,1,STAB WOUND TO LEFT CHEST,23.0,"Injury, poisoning and procedural complications",Stab wound,Stab wound,Non-site specific injuries NEC,Injuries NEC,03SEP2017,03SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06NOV2017,06NOV2017,Medication,No,No,No,No,8.1,No,No
108-191,6001,1,Bacterial skin infection of right arm,23.0,Infections and infestations,Skin bacterial infection,Skin bacterial infection,Bacterial infections NEC,Bacterial infectious disorders,15MAY2017,15MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,13JUN2017,13JUN2017,Medication,No,No,No,No,3,No,No
108-191,6002,2,Haematuria,23.0,Renal and urinary disorders,Haematuria,Haematuria,Urinary abnormalities,Urinary tract signs and symptoms,23MAY2017,23MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JUN2017,06JUN2017,None,No,No,No,No,3,No,No
108-191,6003,3,Bacterial skin infection on bilateral hands,23.0,Infections and infestations,Skin bacterial infection,Skin bacterial infection,Bacterial infections NEC,Bacterial infectious disorders,17JUL2017,17JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08AUG2017,08AUG2017,Medication,No,No,No,No,6,No,No
108-191,6004,4,Elavated serum creatinine from baseline,23.0,Investigations,Blood creatinine increased,Increased serum creatinine,Renal function analyses,Renal and urinary tract investigations and urinalyses,16AUG2017,16AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,24OCT2017,24OCT2017,None,No,No,No,No,7,No,No
108-191,6005,5,Elevated serum creatinine from baseline,23.0,Investigations,Blood creatinine increased,Increased serum creatinine,Renal function analyses,Renal and urinary tract investigations and urinalyses,24OCT2017,24OCT2017,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,30OCT2017,30OCT2017,None,No,No,No,No,8,No,No
108-191,6006,6,Post alcohol intoxication syptoms,23.0,Psychiatric disorders,Alcoholic hangover,Alcoholic hangover,Substance related and addictive disorders,Psychiatric disorders NEC,AUG2017,15AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,SEP2017,15SEP2017,None,No,No,No,No,8.1,No,No
108-396,6001,1,Elevated serum creatinine from baseline,23.0,Investigations,Blood creatinine increased,Increased serum creatinine,Renal function analyses,Renal and urinary tract investigations and urinalyses,21NOV2017,21NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27NOV2017,27NOV2017,Other,No,No,No,No,10,No,No
108-463,6001,1,Flu-like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,05MAY2017,05MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07MAY2017,07MAY2017,Medication,No,No,No,No,3,No,No
108-463,6002,2,Flu-like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,30JUL2017,30JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04AUG2017,04AUG2017,Medication,No,No,No,No,7,No,No
108-420,6001,1,Asymptomatic trichomonas vaginalis bacteriuria,23.0,Infections and infestations,Vulvovaginitis trichomonal,Vaginitis trichomonal,Trichomonas infections,Protozoal infectious disorders,23APR2018,23APR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,23APR2018,23APR2018,Medication,No,No,No,No,12,No,No
108-250,6001,1,Elevated Blood Pressure,23.0,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),13NOV2017,13NOV2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02FEB2018,02FEB2018,None,No,No,No,No,10,No,No
108-460,6001,1,FLU-LIKE SYNDROME,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,14JUL2017,14JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUL2017,30JUL2017,None,No,No,No,No,7,No,No
108-460,6002,2,Asymptomatic genetourinary chlamydia trachomatis,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,12APR2018,12APR2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12APR2018,12APR2018,Medication,No,No,No,No,12,No,No
108-378,6001,1,Flu-like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,22JUN2017,22JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26JUN2017,26JUN2017,Medication,No,No,No,No,4,No,No
108-004,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,03JUL2017,03JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17JUL2017,17JUL2017,None,No,No,No,No,3,No,No
108-004,6002,2,Haematuria,23.0,Renal and urinary disorders,Haematuria,Haematuria,Urinary abnormalities,Urinary tract signs and symptoms,03JUL2017,03JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31JUL2017,31JUL2017,None,No,No,No,No,3,No,No
108-004,6003,3,Papular rash on medial aspect of left foot,23.0,Skin and subcutaneous tissue disorders,Rash papular,Papular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,10JUL2017,10JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,06AUG2017,06AUG2017,Medication,No,No,No,No,5,No,No
108-004,6004,4,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,31JUL2017,31JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11SEP2017,11SEP2017,None,No,No,No,No,5,No,No
108-004,6005,5,Insect bites on right arm and right buttock.,23.0,"Injury, poisoning and procedural complications",Arthropod bite,Insect bite NOS,Non-site specific injuries NEC,Injuries NEC,28NOV2017,28NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08DEC2017,08DEC2017,None,No,No,No,No,8,No,No
108-361,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,06DEC2017,06DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14DEC2017,14DEC2017,None,No,No,No,No,10,No,No
108-361,6002,2,Asymptomatic bacterial vaginosis,23.0,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,06DEC2017,06DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12DEC2017,12DEC2017,Medication,No,No,No,No,10,No,No
108-397,6001,1,headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,09JUL2017,09JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10JUL2017,10JUL2017,Medication,No,No,No,No,3,No,No
108-397,6002,2,Elevated ALT,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,03AUG2017,03AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10AUG2017,10AUG2017,None,No,No,No,No,5,No,No
108-397,6003,3,Asymptomatic genitourinary neisseria gonorrhoeae,23.0,Infections and infestations,Genitourinary tract gonococcal infection,Genitourinary tract gonococcal infection,Neisseria infections,Bacterial infectious disorders,21DEC2017,21DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21DEC2017,21DEC2017,Medication,No,No,No,No,10,No,No
108-497,6001,1,LOWER BACKACHE,23.0,Musculoskeletal and connective tissue disorders,Back pain,Low back ache,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,20MAY2017,20MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28MAY2017,28MAY2017,Medication,No,No,No,No,5.1,No,No
108-497,6002,2,Right ankle sprain,23.0,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,10SEP2017,10SEP2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14SEP2017,14SEP2017,Medication,No,No,No,No,9,No,No
108-497,6003,3,Cough,23.0,"Respiratory, thoracic and mediastinal disorders",Cough,Cough,Coughing and associated symptoms,Respiratory disorders NEC,16SEP2017,16SEP2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,OCT2017,15OCT2017,Medication,No,No,No,No,10,No,No
108-312,6001,1,Headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,03JUN2017,03JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,11JUN2017,11JUN2017,Medication,No,No,No,No,5.1,No,No
108-312,6002,2,Headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,01AUG2017,01AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06AUG2017,06AUG2017,Medication,No,No,No,No,7.1,No,No
108-090,6001,1,MALE URETHRITIS SYNDROME,23.0,Infections and infestations,Urethritis,Urethritis,Urinary tract infections,Infections - pathogen unspecified,08MAY2017,08MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14MAY2017,14MAY2017,Medication,No,No,No,No,3,No,No
108-090,6002,2,Flu-like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,11JUN2017,11JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14JUN2017,14JUN2017,None,No,No,No,No,5,No,No
108-149,6001,1,elevated createnine level,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,29NOV2017,29NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09MAR2018,09MAR2018,None,No,No,No,No,10,No,No
108-262,6001,1,UPPER RESPIRATORY TRACT INFECTION,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,20MAY2017,20MAY2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30MAY2017,30MAY2017,Medication,No,No,No,No,3,No,No
108-269,6001,1,Lower backache,23.0,Musculoskeletal and connective tissue disorders,Back pain,Low back ache,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,25JUL2017,25JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28JUL2017,28JUL2017,None,No,No,No,No,5.1,No,No
108-072,6001,1,Glycosuria,23.0,Renal and urinary disorders,Glycosuria,Glycosuria,Urinary abnormalities,Urinary tract signs and symptoms,12JUN2017,12JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02OCT2017,02OCT2017,None,No,No,No,No,3,No,No
108-072,6002,2,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,28NOV2017,28NOV2017,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,10,No,No
108-072,6003,3,Dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis,Dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,05DEC2017,05DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20DEC2017,20DEC2017,Medication,No,No,No,No,10.1,No,No
108-072,6004,4,Elevated createnine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,28NOV2017,28NOV2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15MAR2018,15MAR2018,None,No,No,No,No,10,No,No
108-219,6001,1,Increased Alkaline phosphatase level,23.0,Investigations,Blood alkaline phosphatase increased,Alkaline phosphatase increased,Tissue enzyme analyses NEC,Enzyme investigations NEC,18JUL2017,18JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10AUG2017,10AUG2017,None,No,No,No,No,3,No,No
108-219,6002,2,Elevated Createnine level,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,04JAN2018,04JAN2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29MAR2018,29MAR2018,None,No,No,No,No,10,No,No
108-292,6001,1,Headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,11OCT2017,11OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11OCT2017,11OCT2017,None,No,No,No,No,7,No,No
108-292,6002,2,elevated creatinine level,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,03JAN2018,03JAN2018,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,03APR2018,03APR2018,None,No,No,No,No,10,No,No
108-013,6001,1,Acute Nasopharyngitis,23.0,Infections and infestations,Nasopharyngitis,Acute nasopharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,23JUL2017,23JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03AUG2017,03AUG2017,Medication,No,No,No,No,3,No,No
108-322,6001,1,grade 1 elevated alkaline phosphatase,23.0,Investigations,Blood alkaline phosphatase increased,Alkaline phosphatase increased,Tissue enzyme analyses NEC,Enzyme investigations NEC,27DEC2017,27DEC2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12APR2018,12APR2018,None,No,No,No,No,10,No,No
108-138,6001,1,itchy vaginal labia,23.0,Reproductive system and breast disorders,Vulvovaginal pruritus,Vaginal itching,Vulvovaginal signs and symptoms,Vulvovaginal disorders (excl infections and inflammations),11AUG2017,11AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16AUG2017,16AUG2017,None,No,No,No,No,7,No,No
108-217,6001,1,Upper Respitory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,22JUN2017,22JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,27JUN2017,27JUN2017,Medication,No,No,No,No,5,No,No
108-374,6001,1,UPPER RESPIRATORY TRACT INFECTION,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,26JUN2017,26JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,09JUL2017,09JUL2017,Medication,No,No,No,No,3,No,No
108-374,6002,2,ELEVATED ALT LEVELS,23.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,03OCT2017,03OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06DEC2017,06DEC2017,None,No,No,No,No,7,No,No
108-516,6001,1,HEADACHE,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,25JUN2017,25JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28JUN2017,28JUN2017,Medication,No,No,No,No,3,No,No
108-516,6002,2,POSSIBLE PEPTIC ULCER DISEASE,23.0,Gastrointestinal disorders,Peptic ulcer,Peptic ulcer disease,Peptic ulcers and perforation,Gastrointestinal ulceration and perforation,03JUL2017,03JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07JUL2017,07JUL2017,"Medication, Other",No,No,No,No,3.1,No,No
108-516,6003,3,Abscess lower molar tooth on theleft,23.0,Infections and infestations,Tooth abscess,Tooth abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,03DEC2017,03DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12DEC2017,12DEC2017,Medication,No,No,No,No,10,No,No
108-469,6001,1,Urinary tract infection,23.0,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,08JUL2017,08JUL2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13JUL2017,13JUL2017,Medication,No,No,No,No,3,No,No
108-469,6002,2,HEADACHE,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,06AUG2017,06AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,08AUG2017,08AUG2017,Medication,No,No,No,No,5,No,No
108-469,6003,3,Urinary tract infection,23.0,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,25SEP2017,25SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,07OCT2017,07OCT2017,Medication,No,No,No,No,7,No,No
108-469,6005,5,Asymptomatic Genitourinary Chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,22DEC2017,22DEC2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22JAN2018,22JAN2018,Medication,No,No,No,No,10,No,No
108-469,6006,6,ASYMPTOMATIC GENITOURINARY CHLAMYDIA INFECTION,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,26JUN2018,26JUN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27JUN2018,27JUN2018,Medication,No,No,No,No,12,No,No
108-477,6002,2,symptomatic genitourinary chlamydia infection,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,01DEC2017,01DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,18DEC2017,18DEC2017,Medication,No,No,No,No,8,No,No
108-080,6001,1,"Itchy rash on face, chest and arms.",23.0,Skin and subcutaneous tissue disorders,Rash pruritic,Pruritic rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,16JUN2017,16JUN2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,24JUN2017,24JUN2017,Medication,No,No,No,No,3,No,No
108-080,6002,2,Rash on R + L hands on proximal phalanges,23.0,Skin and subcutaneous tissue disorders,Rash,Hand rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,21JUL2017,21JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUL2017,30JUL2017,Medication,No,No,No,No,5.1,No,No
108-080,6003,3,INTERMITTANT RIGHT ARM PAIN,23.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Painful R arm,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,21JUL2017,21JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUL2017,30JUL2017,Medication,No,No,No,No,5.1,No,No
108-080,6005,5,FINE PAPULAR ITCHY RASH ON LEFT AND RIGHT ARMS,23.0,Skin and subcutaneous tissue disorders,Rash papular,Papular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,11SEP2017,11SEP2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,20NOV2017,20NOV2017,Medication,No,No,No,No,7,No,No
108-301,6002,2,Flu like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,20JUL2017,20JUL2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,08AUG2017,08AUG2017,Medication,No,No,No,No,3,No,No
108-287,6001,1,Elevated Blood Pressure,23.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),21AUG2017,21AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04SEP2017,04SEP2017,Other,No,No,No,No,4,No,No
108-287,6004,4,Elevated Alkaline Phosphatase,23.0,Investigations,Blood alkaline phosphatase increased,Alkaline phosphatase increased,Tissue enzyme analyses NEC,Enzyme investigations NEC,04SEP2017,04SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21NOV2017,21NOV2017,None,No,No,No,No,5,No,No
108-287,6007,7,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,22JAN2018,22JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28JAN2018,28JAN2018,Medication,No,No,No,No,9,No,No
108-287,6008,8,Allergic Dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis allergic,Allergic dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,22JAN2018,22JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29JAN2018,29JAN2018,Medication,No,No,No,No,9,No,No
108-283,6001,1,Raised Creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,02NOV2017,02NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14DEC2017,14DEC2017,None,No,No,No,No,7,No,No
108-283,6002,2,Symptomatic Internal Haemorrhoids,23.0,Gastrointestinal disorders,Haemorrhoids,Internal haemorrhoids,Haemorrhoids and gastrointestinal varices (excl oesophageal),Gastrointestinal vascular conditions,02NOV2017,02NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,12NOV2017,12NOV2017,Medication,No,No,No,No,7.1,No,No
108-283,6003,3,Raised creatinine from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,15JAN2018,15JAN2018,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,29JAN2018,29JAN2018,None,No,No,No,No,8,No,No
108-166,6001,1,Contact Dermatitis,23.0,Skin and subcutaneous tissue disorders,Dermatitis contact,Contact dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,11OCT2017,11OCT2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30NOV2017,30NOV2017,Medication,No,No,No,No,6,No,No
108-146,6001,1,Elevated Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,13NOV2017,13NOV2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16NOV2017,16NOV2017,None,No,No,No,No,7,No,No
108-267,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,27SEP2017,27SEP2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07OCT2017,07OCT2017,None,No,No,No,No,5,No,No
108-267,6002,2,Abnormal Uterine Bleeding Secondary to Contraceptives,23.0,Reproductive system and breast disorders,Dysfunctional uterine bleeding,Dysfunctional uterine bleeding,Menstruation and uterine bleeding NEC,Menstrual cycle and uterine bleeding disorders,15MAY2018,15MAY2018,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20MAY2018,20MAY2018,"Medication, New/Prolonged Hospitalization",Yes,Yes,Yes,Yes,11,No,No
108-313,6001,1,Headache,23.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,30AUG2017,30AUG2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31AUG2017,31AUG2017,Medication,No,No,No,No,3,No,No
108-313,6002,2,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,02OCT2017,02OCT2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06OCT2017,06OCT2017,None,No,No,No,No,5,No,No
108-313,6003,3,Elevated Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,28NOV2017,28NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,04DEC2017,04DEC2017,None,No,No,No,No,7,No,No
108-313,6004,4,Sore Throat,23.0,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,01DEC2017,01DEC2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03DEC2017,03DEC2017,Medication,No,No,No,No,7.1,No,No
108-313,6005,5,Intermittent Toothache,23.0,Gastrointestinal disorders,Toothache,Toothache,Dental pain and sensation disorders,Dental and gingival conditions,19FEB2018,19FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28FEB2018,28FEB2018,Medication,No,No,No,No,10,No,No
108-321,6001,1,Viral upper respiratory tract infection,23.0,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,18FEB2018,18FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,06MAR2018,06MAR2018,Medication,No,No,No,No,9,No,No
108-277,6001,1,Creatinine raised from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,01NOV2017,01NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15NOV2017,15NOV2017,None,No,No,No,No,3,No,No
108-277,6002,2,Creatinine raised from baseline,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,29NOV2017,29NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,13DEC2017,13DEC2017,None,No,No,No,No,5,No,No
108-213,6001,1,Flu-like Syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,20NOV2017,20NOV2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28NOV2017,28NOV2017,Medication,No,No,No,No,4,No,No
108-213,6002,2,Acute gastroenteritis,23.0,Infections and infestations,Gastroenteritis,Acute gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,09DEC2017,09DEC2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11DEC2017,11DEC2017,None,No,No,No,No,5,No,No
108-333,6001,1,Right Lower Molar Tooth Decay,23.0,Gastrointestinal disorders,Dental caries,Tooth decay,Dental and periodontal infections and inflammations,Dental and gingival conditions,APR2018,15APR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,30MAY2018,30MAY2018,Procedure/Surgery,No,No,No,No,8,No,No
108-180,6001,1,Bilateral Axillary Lymphadenopathy,23.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",14MAR2018,14MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26APR2018,26APR2018,"Medication, Other",No,No,No,No,5,No,No
108-180,6002,2,Flu-like syndrome,23.0,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,19JUL2018,19JUL2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28JUL2018,28JUL2018,Medication,No,No,No,No,10,No,No
108-418,6001,1,Acute Diarrhoea,23.0,Gastrointestinal disorders,Diarrhoea,Acute diarrhoea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,20MAR2018,20MAR2018,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,21MAR2018,21MAR2018,Medication,No,No,No,No,5,No,No
108-418,6003,3,Right axillary pain and tenderness,23.0,General disorders and administration site conditions,Axillary pain,Axillary pain,Pain and discomfort NEC,General system disorders NEC,14MAY2018,14MAY2018,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,19MAY2018,19MAY2018,Medication,No,No,No,No,6,No,No
108-210,6001,1,Burns right forearm,23.0,"Injury, poisoning and procedural complications",Thermal burn,Burn of unspecified degree of forearm,Thermal burns,Injuries by physical agents,27MAY2017,27MAY2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,31JUL2017,31JUL2017,Medication,No,No,No,No,4,No,No
108-210,6002,2,Asymptomatic Genitourinary Chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,06NOV2017,06NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14NOV2017,14NOV2017,"Medication, Other",No,No,No,No,10,No,No
108-395,6001,1,Proteinuria,23.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,21NOV2017,21NOV2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16FEB2018,16FEB2018,"Medication, Other",No,No,No,No,10,No,No
108-395,6002,2,Hematuria,23.0,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,21NOV2017,21NOV2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29NOV2017,29NOV2017,None,No,No,No,No,10,No,No
108-457,6001,1,Upper Respiratory Tract Infection,23.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,14JUN2017,14JUN2017,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16JUN2017,16JUN2017,"Medication, Other",No,No,No,No,2.1,No,No
108-281,6001,1,Asymptomatic Genitourinary Gonorrhoea,23.0,Infections and infestations,Genitourinary tract gonococcal infection,Genitourinary tract gonococcal infection,Neisseria infections,Bacterial infectious disorders,18JAN2018,18JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,05MAR2018,05MAR2018,"Medication, Other",No,No,No,No,10,No,No
108-281,6002,2,Increased Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,18JAN2018,18JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,17JUL2018,17JUL2018,None,No,No,No,No,10,No,No
108-281,6003,3,Asymptomatic Genitourinary Chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,16JUL2018,16JUL2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,Other,No,No,No,No,12,No,No
108-336,6001,1,Haematuria,23.0,Renal and urinary disorders,Haematuria,Haematuria,Urinary abnormalities,Urinary tract signs and symptoms,07AUG2017,07AUG2017,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16AUG2017,16AUG2017,None,No,No,No,No,3,No,No
108-388,6001,1,Increased Creatinine,23.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,25JAN2018,25JAN2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,18JUL2018,18JUL2018,None,No,No,No,No,10,No,No
108-038,6001,1,Asymptomatic Genitourinary Chlamydia,23.0,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,02FEB2018,02FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04MAY2018,04MAY2018,"Medication, Other",No,No,No,No,10,No,No
108-038,6002,2,Asymptomatic Genitourinary Gonorrhoea,23.0,Infections and infestations,Genitourinary tract gonococcal infection,Genitourinary tract gonococcal infection,Neisseria infections,Bacterial infectious disorders,02FEB2018,02FEB2018,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04MAY2018,04MAY2018,"Medication, Other",No,No,No,No,10,No,No