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
098-056,6001,1,Pharyngitis,21.0,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,13OCT2015,13OCT2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18OCT2015,18OCT2015,None,No,No,No,No,4,No,No
098-056,6002,2,Viral illness flu like,21.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,14DEC2015,14DEC2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,22DEC2015,22DEC2015,Medication,No,No,No,No,8,No,No
098-050,6001,1,Increased ALT,21.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,26OCT2015,26OCT2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16NOV2015,16NOV2015,None,No,No,No,No,3,No,No
098-050,6002,2,Increased creatinine,21.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,11APR2016,11APR2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27APR2016,27APR2016,None,No,No,No,No,9,No,No
098-073,6001,1,Bruise Right lateral upper arm,21.0,"Injury, poisoning and procedural complications",Contusion,Bruising of arm,Skin injuries NEC,Injuries NEC,08DEC2015,08DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22DEC2015,22DEC2015,None,No,No,No,No,5,No,No
098-073,6002,2,VIRAL ILLNESS,21.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,03JAN2016,03JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05JAN2016,05JAN2016,None,No,No,No,No,6,No,No
098-052,6001,1,VIRAL PHARYNGITIS,21.0,Infections and infestations,Viral pharyngitis,Viral pharyngitis,Viral infections NEC,Viral infectious disorders,26NOV2015,26NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30NOV2015,30NOV2015,None,No,No,No,No,4,No,No
098-052,6002,2,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08FEB2016,08FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,11FEB2016,11FEB2016,Medication,No,No,No,No,7,No,No
098-052,6003,3,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,19APR2016,19APR2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16MAY2016,16MAY2016,Medication,No,No,No,No,9,No,No
098-010,6001,1,Pruritis at injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,04MAY2016,04MAY2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,06MAY2016,06MAY2016,None,No,No,No,No,6,No,No
098-010,6002,2,Upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,19OCT2016,19OCT2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28OCT2016,28OCT2016,None,No,No,No,No,10,No,No
098-099,6001,1,VIRAL ILLNESS,21.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,11JAN2016,11JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22JAN2016,22JAN2016,Medication,No,No,No,No,3,No,No
098-099,6002,2,Upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26MAR2016,26MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20APR2016,20APR2016,Medication,No,No,No,No,6,No,No
098-099,6003,3,Pruritis at injection site - left deltoid,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,06APR2016,06APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,13APR2016,13APR2016,None,No,No,No,No,6,No,No
098-099,6004,4,Exacerbation of anxiety,21.0,Psychiatric disorders,Anxiety,Exacerbation of anxiety,Anxiety symptoms,Anxiety disorders and symptoms,MAR2016,15MAR2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,19SEP2016,19SEP2016,Medication,No,No,No,No,8,No,No
098-099,6005,5,Pruritis at injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,24JUN2016,24JUN2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26JUN2016,26JUN2016,None,No,No,No,No,8,No,No
098-057,6001,1,PRURITUS AT INJECTION SITE RIGHT ARM,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,15JAN2016,15JAN2016,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,22JAN2016,22JAN2016,None,No,No,No,No,2,No,No
098-057,6002,2,pruritis at injection site - right arm,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,12FEB2016,12FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18FEB2016,18FEB2016,None,No,No,No,No,4,No,No
098-057,6004,4,Pruritis at injection site - right arm,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,24MAR2016,24MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,02APR2016,02APR2016,None,No,No,No,No,6,No,No
098-057,6005,5,Bruising at injection site-Right arm (4x4 cm),21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,30MAR2016,30MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,02APR2016,02APR2016,None,No,No,No,No,6,No,No
098-057,6006,6,pruritis at injection site.,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,17JUN2016,17JUN2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30JUN2016,30JUN2016,None,No,No,No,No,8,No,No
098-057,6007,7,Viral illness,21.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,17JAN2017,17JAN2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,25JAN2017,25JAN2017,Medication,No,No,No,No,11,No,No
098-017,6001,1,Pruritus at injection site (right arm),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,22JUL2016,22JUL2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,25JUL2016,25JUL2016,None,No,No,No,No,8,No,No
098-032,6001,1,Pruritis at injection sites (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,27FEB2016,27FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,04MAR2016,04MAR2016,None,No,No,No,No,2,No,No
098-032,6002,2,Pruritis at injection site (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,01APR2016,01APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,08APR2016,08APR2016,None,No,No,No,No,4,No,No
098-032,6003,3,Myopic astigmatism,21.0,Eye disorders,Astigmatism,Myopic astigmatism,Refractive and accommodative disorders,Vision disorders,26APR2016,26APR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26APR2016,26APR2016,Procedure/Surgery,No,No,No,No,6,No,No
098-032,6004,4,Pruritis at injection sites bilateral,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,08MAY2016,08MAY2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,11MAY2016,11MAY2016,None,No,No,No,No,6,No,No
098-032,6005,5,Pruritis @ injection site (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,12AUG2016,12AUG2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20AUG2016,20AUG2016,None,No,No,No,No,8,No,No
098-032,6006,6,Myopic astigmatism,21.0,Eye disorders,Astigmatism,Myopic astigmatism,Refractive and accommodative disorders,Vision disorders,30AUG2016,30AUG2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30AUG2016,30AUG2016,Procedure/Surgery,No,No,No,No,10,No,No
098-072,6001,1,Gastroenteritis,21.0,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,16AUG2016,16AUG2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,19AUG2016,19AUG2016,None,No,No,No,No,8,No,No
098-074,6001,1,Pruritis at injection site-left arm,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,17MAR2016,17MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18MAR2016,18MAR2016,None,No,No,No,No,2,No,No
098-074,6002,2,Elevated creatinine,21.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,30MAR2016,30MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25MAY2016,25MAY2016,None,No,No,No,No,3,No,No
098-074,6003,3,Upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18APR2016,18APR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,03MAY2016,03MAY2016,Medication,No,No,No,No,4,No,No
098-074,6004,4,Elevated creatinine,21.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,29AUG2016,29AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01DEC2016,01DEC2016,None,No,No,No,No,9,No,No
098-074,6005,5,Myopia,21.0,Eye disorders,Myopia,Myopia,Refractive and accommodative disorders,Vision disorders,24NOV2016,24NOV2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24NOV2016,24NOV2016,Procedure/Surgery,No,No,No,No,10,No,No
098-074,6006,6,Depression (situational),21.0,Psychiatric disorders,Adjustment disorder with depressed mood,Situational depression,Adjustment disorders,Adjustment disorders (incl subtypes),FEB2017,15FEB2017,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
098-026,6001,1,Bruising at injection site - left arm 1.5 cm x 2.5 cm,21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,22MAR2016,22MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,28MAR2016,28MAR2016,None,No,No,No,No,3,No,No
098-026,6002,2,Elevated Creatine Kinase,21.0,Investigations,Blood creatine phosphokinase increased,Creatine kinase increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,24MAR2016,24MAR2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,04APR2016,04APR2016,None,No,No,No,No,3,No,No
098-026,6003,3,Elevated AST,21.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,24MAR2016,24MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04APR2016,04APR2016,None,No,No,No,No,3,No,No
098-026,6004,4,Upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04APR2016,04APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,14APR2016,14APR2016,None,No,No,No,No,4,No,No
098-026,6005,5,Tonsillitis,21.0,Infections and infestations,Tonsillitis,Tonsillitis,Upper respiratory tract infections,Infections - pathogen unspecified,13JUN2016,13JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19JUN2016,19JUN2016,Medication,No,No,No,No,8,No,No
098-015,6001,1,Pruritis at injection site (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,17APR2016,17APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,19APR2016,19APR2016,None,No,No,No,No,3,No,No
098-015,6002,2,Pruritis at injection sites (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,19MAY2016,19MAY2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,23MAY2016,23MAY2016,None,No,No,No,No,4,No,No
098-015,6004,4,burning sensation to hands (bilateral),21.0,Nervous system disorders,Burning sensation,Extremities burning sensation of,Paraesthesias and dysaesthesias,Neurological disorders NEC,18JUN2016,18JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20JUL2016,20JUL2016,Medication,No,No,No,No,6,No,No
098-015,6005,5,Pruritis at injection sites,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,12JUL2016,12JUL2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,16JUL2016,16JUL2016,None,No,No,No,No,6,No,No
098-015,6006,6,Pnuemonia,21.0,Infections and infestations,Pneumonia,Pneumonia,Lower respiratory tract and lung infections,Infections - pathogen unspecified,24SEP2016,24SEP2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,24OCT2016,24OCT2016,Medication,No,No,No,No,8,No,No
098-015,6007,7,Proteinuria,21.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,26OCT2016,26OCT2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10NOV2016,10NOV2016,None,No,No,No,No,8,No,No
098-015,6008,8,Pruritis at injection sites (bilateral),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,27OCT2016,27OCT2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,03NOV2016,03NOV2016,None,No,No,No,No,8,No,No
098-093,6001,1,Abscess left upper molar,21.0,Infections and infestations,Tooth abscess,Tooth abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,21FEB2017,21FEB2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26FEB2017,26FEB2017,Medication,No,No,No,No,11,No,No
098-048,6001,1,Pruritis at injection site (left arm),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,21JUL2016,21JUL2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,29JUL2016,29JUL2016,None,No,No,No,No,6,No,No
098-048,6002,2,Vaginitis,21.0,Infections and infestations,Vaginal infection,Vaginitis,Female reproductive tract infections,Infections - pathogen unspecified,01APR2017,01APR2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,07APR2017,07APR2017,Medication,No,No,No,No,11,No,No
098-086,6001,1,Increased ALT,21.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,20JUN2016,20JUN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20JUL2016,20JUL2016,None,No,No,No,No,5,No,No
098-086,6002,2,Schizophrenia,21.0,Psychiatric disorders,Schizophrenia,Schizophrenia,Schizophrenia NEC,Schizophrenia and other psychotic disorders,OCT2017,15OCT2017,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
098-044,6001,1,Herpes simples - right lower lip,21.0,Infections and infestations,Oral herpes,Herpes on lip,Herpes viral infections,Viral infectious disorders,19MAY2016,19MAY2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21MAY2016,21MAY2016,Medication,No,No,No,No,4,No,No
098-012,6001,1,Pruritis at injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,19MAY2016,19MAY2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,21MAY2016,21MAY2016,None,No,No,No,No,2,No,No
098-082,6001,1,Strep throat,21.0,Infections and infestations,Pharyngitis streptococcal,Streptococcal sore throat,Streptococcal infections,Bacterial infectious disorders,03JUN2016,03JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15JUN2016,15JUN2016,Medication,No,No,No,No,3,No,No
098-082,6002,2,Enlarged tonsils,21.0,"Respiratory, thoracic and mediastinal disorders",Tonsillar hypertrophy,Enlarged tonsils,Pharyngeal disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),16JUL2016,16JUL2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16JUL2016,16JUL2016,Procedure/Surgery,No,No,No,No,6,No,No
098-082,6003,3,Elevated CK,21.0,Investigations,Blood creatine phosphokinase increased,CK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,15FEB2017,15FEB2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,11MAY2017,11MAY2017,None,No,No,No,No,10,No,No
098-053,6001,1,chest congestion,21.0,"Respiratory, thoracic and mediastinal disorders",Lower respiratory tract congestion,Lower respiratory tract congestion,Lower respiratory tract signs and symptoms,Respiratory tract signs and symptoms,23DEC2015,23DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,06JAN2016,06JAN2016,Medication,No,No,No,No,8,No,No
098-053,6002,2,COPD,21.0,"Respiratory, thoracic and mediastinal disorders",Chronic obstructive pulmonary disease,COPD,Bronchospasm and obstruction,Bronchial disorders (excl neoplasms),MAR2016,15MAR2016,Mild,Mild,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
098-053,6003,3,Folliculitis,21.0,Infections and infestations,Folliculitis,Folliculitis,Skin structures and soft tissue infections,Infections - pathogen unspecified,03AUG2016,03AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,13AUG2016,13AUG2016,Medication,No,No,No,No,11,No,No
098-053,6004,4,Otitis Media,21.0,Infections and infestations,Otitis media,Otitis media,Ear infections,Infections - pathogen unspecified,03AUG2016,03AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,13AUG2016,13AUG2016,Medication,No,No,No,No,11,No,No
098-053,6005,5,chest pain,21.0,General disorders and administration site conditions,Chest pain,Chest pain,Pain and discomfort NEC,General system disorders NEC,17DEC2016,17DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,17DEC2016,17DEC2016,None,No,No,No,No,12,No,No
098-066,6001,1,pre-syncope,21.0,Nervous system disorders,Presyncope,Pre-syncope,Neurological signs and symptoms NEC,Neurological disorders NEC,22OCT2015,22OCT2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,22OCT2015,22OCT2015,Other,No,No,No,No,2,No,No
098-066,6002,2,bilateral arm weakness,21.0,Musculoskeletal and connective tissue disorders,Muscular weakness,Muscle weakness upper limb,Muscle weakness conditions,Muscle disorders,27OCT2015,27OCT2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,28OCT2015,28OCT2015,None,No,No,No,No,2,No,No
098-066,6003,3,back strain,21.0,"Injury, poisoning and procedural complications",Muscle strain,Back strain,"Muscle, tendon and ligament injuries",Injuries NEC,15MAY2016,15MAY2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,18MAY2016,18MAY2016,Medication,No,No,No,No,11,No,No
098-066,6004,4,influenza,21.0,Infections and infestations,Influenza,Influenza,Influenza viral infections,Viral infectious disorders,14FEB2017,14FEB2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21FEB2017,21FEB2017,Medication,No,No,No,No,12,No,No
098-031,6001,1,sinus congestion,21.0,"Respiratory, thoracic and mediastinal disorders",Sinus congestion,Sinus congestion,Paranasal sinus disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),05DEC2015,05DEC2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,18DEC2015,18DEC2015,Medication,No,No,No,No,6,No,No
098-031,6002,2,viral illness,21.0,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,20DEC2015,20DEC2015,Moderate,Moderate,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,27DEC2015,27DEC2015,Medication,No,No,No,No,6,No,No
098-031,6003,3,Left arm pain,21.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Painful L arm,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,16FEB2016,16FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20FEB2016,20FEB2016,Medication,No,No,No,No,8,No,No
098-031,6004,4,Influenza,21.0,Infections and infestations,Influenza,Influenza,Influenza viral infections,Viral infectious disorders,04MAR2016,04MAR2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21MAR2016,21MAR2016,Medication,No,No,No,No,9,No,No
098-031,6005,5,Diarrhea,21.0,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,07MAY2016,07MAY2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16MAY2016,16MAY2016,Medication,No,No,No,No,10,No,No
098-031,6006,6,Sinus congestion,21.0,"Respiratory, thoracic and mediastinal disorders",Sinus congestion,Sinus congestion,Paranasal sinus disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),03FEB2017,03FEB2017,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,12,No,No
098-019,6001,1,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,17JAN2016,17JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21JAN2016,21JAN2016,None,No,No,No,No,4,No,No
098-019,6003,3,Elevated CPK,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,08APR2016,08APR2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04AUG2016,04AUG2016,None,No,No,No,No,9,No,No
098-039,6001,1,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24JAN2016,24JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,24JAN2016,24JAN2016,Medication,No,No,No,No,5,No,No
098-039,6002,2,elevated CPK,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,24MAR2016,24MAR2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,08APR2016,08APR2016,Other,No,No,No,No,7,No,No
098-039,6003,3,elevated AST,21.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,24MAR2016,24MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25MAR2016,25MAR2016,None,No,No,No,No,7,No,No
098-039,6004,4,exercise induced myalgias,21.0,Musculoskeletal and connective tissue disorders,Myalgia,Myalgia,Muscle pains,Muscle disorders,20MAR2016,20MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,24MAR2016,24MAR2016,None,No,No,No,No,7,No,No
098-039,6005,5,streptococcal pharyngitis,21.0,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,16JUN2016,16JUN2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20JUN2016,20JUN2016,Medication,No,No,No,No,9,No,No
098-039,6006,6,strep pharyngitis,21.0,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,04AUG2016,04AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,18AUG2016,18AUG2016,Medication,No,No,No,No,10,No,No
098-039,6007,7,strep pharyngitis,21.0,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,08JUN2017,08JUN2017,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
098-076,6001,1,bruising at injection site,21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,05FEB2016,05FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,15FEB2016,15FEB2016,None,No,No,No,No,4,No,No
098-076,6002,2,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,21MAR2016,21MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25MAR2016,25MAR2016,None,No,No,No,No,6,No,No
098-076,6003,3,Elevated CPK level,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,25APR2016,25APR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,28APR2016,28APR2016,None,No,No,No,No,7,No,No
098-076,6004,4,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,12AUG2016,12AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20AUG2016,20AUG2016,Medication,No,No,No,No,10,No,No
098-096,6001,1,Pre-Syncope,21.0,Nervous system disorders,Presyncope,Pre-syncope,Neurological signs and symptoms NEC,Neurological disorders NEC,06JAN2016,06JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,06JAN2016,06JAN2016,Other,No,No,No,No,2,No,No
098-096,6002,2,elevated CPK level,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,08JUL2016,08JUL2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20JUL2016,20JUL2016,None,No,No,No,No,9,No,No
098-096,6003,3,elevated AST level,21.0,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,08JUL2016,08JUL2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20JUL2016,20JUL2016,None,No,No,No,No,9,No,No
098-096,6004,4,elevated ALT level,21.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,08JUL2016,08JUL2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20JUL2016,20JUL2016,None,No,No,No,No,9,No,No
098-096,6005,5,elevated cpk level,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,30SEP2016,30SEP2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Severity/Frequency,Severity/Frequency,13JAN2017,13JAN2017,None,No,No,No,No,10,No,No
098-096,6006,6,flu like illness,21.0,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,27DEC2016,27DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30DEC2016,30DEC2016,None,No,No,No,No,11,No,No
098-096,6007,7,elevated cpk level,21.0,Investigations,Blood creatine phosphokinase increased,CPK increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,13JAN2017,13JAN2017,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,23JAN2017,23JAN2017,None,No,No,No,No,11,No,No
098-030,6001,1,vaginal candidiasis,21.0,Infections and infestations,Vulvovaginal candidiasis,Vaginal candidiasis,Candida infections,Fungal infectious disorders,25FEB2016,25FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25FEB2016,25FEB2016,Medication,No,No,No,No,3,No,No
098-030,6002,2,pregnancy induced hyperemesis,21.0,"Pregnancy, puerperium and perinatal conditions",Hyperemesis gravidarum,Hyperemesis gravidarum,Maternal complications of pregnancy NEC,Maternal complications of pregnancy,DEC2016,15DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27JUL2017,27JUL2017,Medication,No,No,No,No,11,No,No
098-071,6001,1,presyncope,21.0,Nervous system disorders,Presyncope,Presyncope,Neurological signs and symptoms NEC,Neurological disorders NEC,04JAN2016,04JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,04JAN2016,04JAN2016,Other,No,No,No,No,2,No,No
098-071,6002,2,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,03FEB2016,03FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04FEB2016,04FEB2016,None,No,No,No,No,4,No,No
098-071,6003,3,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18FEB2016,18FEB2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26FEB2016,26FEB2016,Medication,No,No,No,No,5,No,No
098-078,6001,1,Avulsion fracture-right ileac fracture,21.0,"Injury, poisoning and procedural complications",Avulsion fracture,Avulsion fracture,Fractures and dislocations NEC,Bone and joint injuries,16JAN2016,16JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05FEB2016,05FEB2016,None,No,No,No,No,4,No,No
098-078,6002,2,poison ivy (outside exposure),21.0,Skin and subcutaneous tissue disorders,Dermatitis contact,Poison ivy rash,Dermatitis and eczema,Epidermal and dermal conditions,02JUN2016,02JUN2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16JUN2016,16JUN2016,Medication,No,No,No,No,9,No,No
098-042,6001,1,Drug Reaction--Ranitidine,21.0,General disorders and administration site conditions,Adverse drug reaction,Adverse drug reaction,Therapeutic and nontherapeutic responses,Therapeutic and nontherapeutic effects (excl toxicity),15JAN2016,15JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19JAN2016,19JAN2016,Medication,No,No,No,No,3,No,No
098-055,6001,1,Presyncope,21.0,Nervous system disorders,Presyncope,Presyncope,Neurological signs and symptoms NEC,Neurological disorders NEC,07JAN2016,07JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,07JAN2016,07JAN2016,Other,No,No,No,No,2,No,No
098-055,6002,2,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15DEC2016,15DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,17DEC2016,17DEC2016,None,No,No,No,No,11,No,No
098-046,6001,1,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,25MAR2016,25MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26MAR2016,26MAR2016,Medication,No,No,No,No,6,No,No
098-068,6001,1,itching at injection site-Right deltoid,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,20FEB2016,20FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,21FEB2016,21FEB2016,None,No,No,No,No,4,No,No
098-068,6002,2,Left strained hamstring,21.0,"Injury, poisoning and procedural complications",Muscle strain,Pulled hamstring,"Muscle, tendon and ligament injuries",Injuries NEC,23APR2016,23APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28APR2016,28APR2016,Other,No,No,No,No,7,No,No
098-068,6003,3,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,09SEP2016,09SEP2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14SEP2016,14SEP2016,Medication,No,No,No,No,10,No,No
098-068,6004,4,Dental abscess,21.0,Infections and infestations,Tooth abscess,Dental abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,05DEC2016,05DEC2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,05DEC2016,05DEC2016,"Medication, Procedure/Surgery",No,No,No,No,11,No,No
098-036,6001,1,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,02FEB2016,02FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04FEB2016,04FEB2016,Medication,No,No,No,No,3,No,No
098-036,6003,3,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26FEB2016,26FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,27FEB2016,27FEB2016,Medication,No,No,No,No,4,No,No
098-036,6004,4,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27FEB2016,27FEB2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAR2016,15MAR2016,Medication,No,No,No,No,4,No,No
098-036,6005,5,Left 2nd toe injury-toenail,21.0,"Injury, poisoning and procedural complications",Limb injury,Toe injury,Site specific injuries NEC,Injuries NEC,08MAR2016,08MAR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,16MAR2016,16MAR2016,Medication,No,No,No,No,5,No,No
098-036,6006,6,URI,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,11APR2016,11APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15APR2016,15APR2016,Medication,No,No,No,No,6,No,No
098-036,6007,7,GI illness,21.0,Infections and infestations,Gastrointestinal infection,Gastrointestinal infection,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,26APR2016,26APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,27APR2016,27APR2016,Medication,No,No,No,No,6,No,No
098-038,6001,1,Pharyngitis,21.0,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,27FEB2016,27FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,28FEB2016,28FEB2016,None,No,No,No,No,2,No,No
098-038,6002,2,illeocolic intussusception,21.0,Gastrointestinal disorders,Intussusception,Ileocolic intussusception,Gastrointestinal stenosis and obstruction NEC,Gastrointestinal stenosis and obstruction,21FEB2017,21FEB2017,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,01MAR2017,01MAR2017,"Medication, New/Prolonged Hospitalization, Procedure/Surgery",Yes,Yes,Yes,Yes,10.1,No,No
098-038,6003,3,post-op pain,21.0,"Injury, poisoning and procedural complications",Procedural pain,Postoperative pain,Non-site specific procedural complications,Procedural related injuries and complications NEC,01MAR2017,01MAR2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,07MAR2017,07MAR2017,Medication,No,No,No,No,11,No,No
098-016,6001,1,Concussion,21.0,"Injury, poisoning and procedural complications",Concussion,Concussion,Cerebral injuries NEC,Injuries NEC,16JUN2016,16JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,,,"Medication, Other",No,No,No,No,7,No,No
098-013,6001,1,Itching at injection site--Right deltoid,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,02MAR2016,02MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,03MAR2016,03MAR2016,None,No,No,No,No,2,No,No
098-013,6002,2,elevated blood pressure,21.0,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),05AUG2016,05AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14NOV2016,14NOV2016,None,No,No,No,No,9,No,No
098-013,6003,3,neck pain-myalgia-right shoulder muscle strain,21.0,"Injury, poisoning and procedural complications",Muscle strain,Muscle strain,"Muscle, tendon and ligament injuries",Injuries NEC,01NOV2016,01NOV2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16NOV2016,16NOV2016,Medication,No,No,No,No,10,No,No
098-013,6004,4,Elevated ALT level,21.0,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,14NOV2016,14NOV2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24FEB2017,24FEB2017,None,No,No,No,No,10,No,No
098-027,6001,1,lumbosacral strain,21.0,"Injury, poisoning and procedural complications",Muscle strain,Lumbosacral strain,"Muscle, tendon and ligament injuries",Injuries NEC,30MAY2016,30MAY2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01JUL2016,01JUL2016,Medication,No,No,No,No,5,No,No
098-091,6001,1,pruritis at injection site/left deltoid,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,24SEP2015,24SEP2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,25SEP2015,25SEP2015,None,No,No,No,No,3,No,No
098-091,6002,2,mastitis left breast,21.0,Infections and infestations,Mastitis,Mastitis,Breast infections,Infections - pathogen unspecified,09NOV2015,09NOV2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,17NOV2015,17NOV2015,Medication,No,No,No,No,5.1,No,No
098-091,6003,3,Right Shoulder Dislocation,21.0,"Injury, poisoning and procedural complications",Joint dislocation,Shoulder dislocation,Fractures and dislocations NEC,Bone and joint injuries,25DEC2015,25DEC2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,26DEC2015,26DEC2015,Other,No,No,No,No,8,No,No
098-091,6004,4,Right Shoulder Dislocation,21.0,"Injury, poisoning and procedural complications",Joint dislocation,Shoulder dislocation,Fractures and dislocations NEC,Bone and joint injuries,04JAN2016,04JAN2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,01APR2016,01APR2016,"Medication, Procedure/Surgery, Other",No,No,No,No,8,No,No
098-091,6005,5,myalgia,21.0,Musculoskeletal and connective tissue disorders,Myalgia,Myalgia,Muscle pains,Muscle disorders,26SEP2016,26SEP2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,28SEP2016,28SEP2016,Medication,No,No,No,No,11,No,No
098-075,6001,1,pruritis at injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,04SEP2015,04SEP2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,05SEP2015,05SEP2015,None,No,No,No,No,2,No,No
098-075,6002,2,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06SEP2015,06SEP2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10SEP2015,10SEP2015,Medication,No,No,No,No,2,No,No
098-075,6003,3,pruritis injection site-right deltoid,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,11OCT2015,11OCT2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,12OCT2015,12OCT2015,None,No,No,No,No,4,No,No
098-075,6004,4,nasal congestion,21.0,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),06NOV2015,06NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08NOV2015,08NOV2015,Medication,No,No,No,No,6,No,No
098-075,6005,5,"rash umbelical area--""Macular Erythematous""",21.0,Skin and subcutaneous tissue disorders,Rash macular,Erythromacular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,11NOV2015,11NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08DEC2015,08DEC2015,Medication,No,No,No,No,6,No,No
098-075,6006,6,pruritis at injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,11FEB2016,11FEB2016,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,12FEB2016,12FEB2016,None,No,No,No,No,8,No,No
098-075,6007,7,allergic sinusitis,21.0,"Respiratory, thoracic and mediastinal disorders",Allergic sinusitis,Allergic sinusitis,Paranasal sinus disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),01MAY2016,01MAY2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16JUN2016,16JUN2016,Medication,No,No,No,No,10,No,No
098-075,6008,8,migraine headaches,21.0,Nervous system disorders,Migraine,Migraine headache,Migraine headaches,Headaches,01MAY2016,01MAY2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16JUN2016,16JUN2016,Medication,No,No,No,No,10,No,No
098-022,6001,1,proteinuria,21.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,16NOV2015,16NOV2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,24NOV2015,24NOV2015,Other,No,No,No,No,3,No,No
098-022,6002,2,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15DEC2015,15DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22DEC2015,22DEC2015,None,No,No,No,No,5,No,No
098-022,6003,3,"bruise at injection site, right arm",21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,23JAN2016,23JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,29JAN2016,29JAN2016,None,No,No,No,No,6,No,No
098-064,6001,1,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10NOV2015,10NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20NOV2015,20NOV2015,None,No,No,No,No,4,No,No
098-064,6002,2,Elevated Blood Pressure,21.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),06JAN2016,06JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22JAN2016,22JAN2016,None,No,No,No,No,6,No,No
098-064,6003,3,nasal congestion,21.0,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),13JAN2016,13JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16JAN2016,16JAN2016,None,No,No,No,No,7,No,No
098-064,6004,4,"aphthous ulcer, oral",21.0,Gastrointestinal disorders,Aphthous ulcer,Ulcer aphthous oral,Stomatitis and ulceration,Oral soft tissue conditions,29APR2016,29APR2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02MAY2016,02MAY2016,None,No,No,No,No,9,No,No
098-064,6005,5,Rash--right/left arms--antecubital spaces,21.0,Skin and subcutaneous tissue disorders,Rash,Rash over arms,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,06JUL2016,06JUL2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,08JUL2016,08JUL2016,Medication,No,No,No,No,10,No,No
098-064,6006,6,Fatigue,21.0,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,14JUL2016,14JUL2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,19JUL2016,19JUL2016,None,No,No,No,No,10,No,No
098-065,6002,2,injection site pruritis (left arm),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,20NOV2015,20NOV2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,24NOV2015,24NOV2015,"Medication, Other",No,No,No,No,2,No,No
098-065,6003,3,nausea,21.0,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,27NOV2015,27NOV2015,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,09DEC2015,09DEC2015,Medication,No,No,No,No,3,No,No
098-065,6004,4,Injection site pruritis (left arm),21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,18DEC2015,18DEC2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20DEC2015,20DEC2015,None,No,No,No,No,4,No,No
098-065,6007,7,kidney stones,21.0,Renal and urinary disorders,Nephrolithiasis,Kidney stones,Renal lithiasis,Urolithiases,11FEB2016,11FEB2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,18FEB2016,18FEB2016,Medication,No,No,No,No,6,No,No
098-065,6008,8,injection site pruritis,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,18FEB2016,18FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20FEB2016,20FEB2016,None,No,No,No,No,6,No,No
098-065,6009,9,depression,21.0,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,14MAY2016,14MAY2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,23MAY2016,23MAY2016,Other,No,No,No,No,8,No,No
098-065,6010,10,depression,21.0,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,08JUN2016,08JUN2016,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02AUG2016,02AUG2016,New/Prolonged Hospitalization,Yes,Yes,Yes,Yes,8,No,No
098-065,6011,11,"weight loss, abnormal",21.0,Metabolism and nutrition disorders,Abnormal loss of weight,Abnormal loss of weight,General nutritional disorders NEC,Appetite and general nutritional disorders,08JUN2016,08JUN2016,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,30SEP2016,30SEP2016,Other,No,No,No,No,9.1,No,No
098-065,6012,12,dehydration,21.0,Metabolism and nutrition disorders,Dehydration,Dehydration,Total fluid volume decreased,Electrolyte and fluid balance conditions,22JUN2016,22JUN2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22JUN2016,22JUN2016,Other,No,No,No,No,9.1,No,No
098-065,6013,13,femur fracture,21.0,"Injury, poisoning and procedural complications",Femur fracture,Femur fracture,Limb fractures and dislocations,Bone and joint injuries,09AUG2016,09AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,DEC2016,15DEC2016,Other,No,No,No,No,10.1,No,No
098-065,6014,14,bruising,21.0,"Injury, poisoning and procedural complications",Contusion,Bruising,Skin injuries NEC,Injuries NEC,25SEP2016,25SEP2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,OCT2016,15OCT2016,None,No,No,No,No,10.1,No,No
098-065,6015,15,nausea,21.0,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,26SEP2016,26SEP2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16OCT2016,16OCT2016,Medication,No,No,No,No,10.1,No,No
098-003,6002,2,"Injection site bruising, left arm",21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,28DEC2015,28DEC2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,13JAN2016,13JAN2016,None,No,No,No,No,3,No,No
098-003,6003,3,"injection site bruising, left arm",21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,16JAN2016,16JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,20JAN2016,20JAN2016,None,No,No,No,No,4,No,No
098-003,6004,4,Abdominal Distension,21.0,Gastrointestinal disorders,Abdominal distension,Abdominal distension,"Flatulence, bloating and distension",Gastrointestinal signs and symptoms,MAY2016,15MAY2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15JUL2016,15JUL2016,None,No,No,No,No,8,No,No
098-009,6001,1,bruise at injection site-Right deltoid,21.0,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,24DEC2015,24DEC2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,04JAN2016,04JAN2016,None,No,No,No,No,2,No,No
098-009,6002,2,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26DEC2015,26DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13JAN2016,13JAN2016,None,No,No,No,No,2,No,No
098-009,6003,3,pre-vaccine anxiety,21.0,"Injury, poisoning and procedural complications",Procedural anxiety,Procedural anxiety,Neurological and psychiatric procedural complications,Procedural related injuries and complications NEC,27JAN2016,27JAN2016,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,27JAN2016,27JAN2016,Medication,No,No,No,No,4,No,No
098-009,6004,4,Upper Respiratory Tract Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,01FEB2016,01FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08FEB2016,08FEB2016,Medication,No,No,No,No,5,No,No
098-009,6005,5,pre vaccine anxiety,21.0,"Injury, poisoning and procedural complications",Procedural anxiety,Procedural anxiety,Neurological and psychiatric procedural complications,Procedural related injuries and complications NEC,09MAR2016,09MAR2016,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,09MAR2016,09MAR2016,Medication,No,No,No,No,6,No,No
098-009,6006,6,Infected Bartholin Cyst,21.0,Infections and infestations,Infected cyst,Infected cyst,Infections NEC,Infections - pathogen unspecified,22MAR2016,22MAR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,19APR2016,19APR2016,Medication,No,No,No,No,7,No,No
098-009,6007,7,pre-vaccination anxiety,21.0,"Injury, poisoning and procedural complications",Procedural anxiety,Procedural anxiety,Neurological and psychiatric procedural complications,Procedural related injuries and complications NEC,08JUN2016,08JUN2016,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,08JUN2016,08JUN2016,Medication,No,No,No,No,8,No,No
098-011,6001,1,bilateral ear canal pain,21.0,Ear and labyrinth disorders,Ear pain,Ear pain,Ear disorders NEC,Aural disorders NEC,13JAN2016,13JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,29JAN2016,29JAN2016,None,No,No,No,No,3,No,No
098-011,6002,2,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,28NOV2016,28NOV2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,02DEC2016,02DEC2016,Medication,No,No,No,No,11,No,No
098-011,6003,3,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,28DEC2016,28DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04JAN2017,04JAN2017,None,No,No,No,No,11,No,No
098-011,6004,4,sprained right ankle,21.0,"Injury, poisoning and procedural complications",Ligament sprain,Sprained ankle,"Muscle, tendon and ligament injuries",Injuries NEC,FEB2017,15FEB2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,MAR2017,15MAR2017,None,No,No,No,No,12,No,No
098-007,6001,1,"Pruritis at Injection Site, Left arm",21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,26MAR2016,26MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,10APR2016,10APR2016,Medication,No,No,No,No,2,No,No
098-007,6002,2,Left ankle sprain,21.0,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,02APR2016,02APR2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,14APR2016,14APR2016,"Medication, Other",No,No,No,No,3,No,No
098-007,6003,3,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15APR2016,15APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25APR2016,25APR2016,Medication,No,No,No,No,3.1,No,No
098-007,6004,4,left lower quadrant pain,21.0,Gastrointestinal disorders,Abdominal pain lower,Left lower quadrant pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,24APR2016,24APR2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,06MAY2016,06MAY2016,Medication,No,No,No,No,4,No,No
098-007,6005,5,"pruritis at injection site, left arm",21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,08JUN2016,08JUN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18JUN2016,18JUN2016,Medication,No,No,No,No,6,No,No
098-007,6006,6,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,22NOV2016,22NOV2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,29NOV2016,29NOV2016,Medication,No,No,No,No,10,No,No
098-069,6001,1,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24MAR2016,24MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26MAR2016,26MAR2016,None,No,No,No,No,2,No,No
098-069,6002,2,Pruritis neck and chest,21.0,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,25MAR2016,25MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,26MAR2016,26MAR2016,None,No,No,No,No,2,No,No
098-069,6003,3,dizziness post vaccine,21.0,"Injury, poisoning and procedural complications",Procedural dizziness,Post procedural dizziness,Neurological and psychiatric procedural complications,Procedural related injuries and complications NEC,26APR2016,26APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,26APR2016,26APR2016,None,No,No,No,No,4,No,No
098-069,6004,4,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27APR2016,27APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,29APR2016,29APR2016,None,No,No,No,No,4,No,No
098-069,6005,5,sore throat,21.0,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,07SEP2016,07SEP2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,10SEP2016,10SEP2016,None,No,No,No,No,8,No,No
098-069,6006,6,sore throat,21.0,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,03OCT2016,03OCT2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,08OCT2016,08OCT2016,None,No,No,No,No,8,No,No
098-069,6007,7,abdominal cramping,21.0,Gastrointestinal disorders,Abdominal pain,Abdominal cramps,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,APR2017,15APR2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,APR2017,15APR2017,Other,No,No,No,No,12,No,No
098-069,6008,8,food poisoning,21.0,Gastrointestinal disorders,Food poisoning,Food poisoning,Gastrointestinal disorders NEC,Gastrointestinal conditions NEC,JUN2017,15JUN2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,JUN2017,15JUN2017,"Medication, Other",No,No,No,No,12,No,No
098-069,6009,9,Dehydration,21.0,Metabolism and nutrition disorders,Dehydration,Dehydration,Total fluid volume decreased,Electrolyte and fluid balance conditions,JUN2017,15JUN2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,JUN2017,15JUN2017,Medication,No,No,No,No,12,No,No
098-047,6001,1,"rash (arms,legs,torso), pruritic",21.0,Skin and subcutaneous tissue disorders,Rash pruritic,Pruritic rash,Pruritus NEC,Epidermal and dermal conditions,31JUL2016,31JUL2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,05AUG2016,05AUG2016,None,No,No,No,No,8,No,No
098-080,6001,1,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24FEB2016,24FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,26FEB2016,26FEB2016,None,No,No,No,No,2,No,No
098-080,6002,2,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26FEB2016,26FEB2016,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,28FEB2016,28FEB2016,Medication,No,No,No,No,2,No,No
098-080,6003,3,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,02MAY2016,02MAY2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,08MAY2016,08MAY2016,Medication,No,No,No,No,6,No,No
098-080,6004,4,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,01JUL2016,01JUL2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,08JUL2016,08JUL2016,Medication,No,No,No,No,8,No,No
098-080,6005,5,suicide attempt,21.0,Psychiatric disorders,Suicide attempt,Suicide attempt,Suicidal and self-injurious behaviour,Suicidal and self-injurious behaviours NEC,04AUG2016,04AUG2016,Potentially life-threatening,Potentially life-threatening,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04AUG2016,04AUG2016,New/Prolonged Hospitalization,Yes,Yes,Yes,Yes,9,No,No
098-080,6006,6,sore throat,21.0,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,05DEC2016,05DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,08DEC2016,08DEC2016,None,No,No,No,No,10.1,No,No
098-080,6007,7,rectal chlamydia-asymptomatic,21.0,Infections and infestations,Proctitis chlamydial,Chlamydial proctitis,Chlamydial infections,Chlamydial infectious disorders,02DEC2016,02DEC2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,09DEC2016,09DEC2016,Medication,No,No,No,No,10.1,No,No
098-080,6008,8,gastric reflux,21.0,Gastrointestinal disorders,Duodenogastric reflux,Duodenogastric reflux,Gastrointestinal atonic and hypomotility disorders NEC,Gastrointestinal motility and defaecation conditions,22AUG2017,22AUG2017,Mild,Mild,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
098-035,6001,1,Increased creatine kinase,21.0,Investigations,Blood creatine phosphokinase increased,Creatine kinase increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,29MAR2016,29MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,07APR2016,07APR2016,Other,No,No,No,No,3,No,No
098-034,6001,1,ear pain,21.0,Ear and labyrinth disorders,Ear pain,Ear pain,Ear disorders NEC,Aural disorders NEC,04MAR2016,04MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,05MAR2016,05MAR2016,None,No,No,No,No,2,No,No
098-034,6002,2,"heart palpitations, beat irregular",21.0,Cardiac disorders,Palpitations,Palpitations,Cardiac signs and symptoms NEC,Cardiac disorder signs and symptoms,11JUN2016,11JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,12JUN2016,12JUN2016,None,No,No,No,No,7,No,No
098-034,6003,3,tongue pain with eating gluten,21.0,General disorders and administration site conditions,Adverse food reaction,Adverse food reaction,Therapeutic and nontherapeutic responses,Therapeutic and nontherapeutic effects (excl toxicity),21NOV2016,21NOV2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15DEC2016,15DEC2016,Other,No,No,No,No,11,No,No
098-081,6001,1,elevated blood pressure,21.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),14JUN2016,14JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,30JUN2016,30JUN2016,None,No,No,No,No,7,No,No
098-081,6002,2,increased creatinine,21.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,20SEP2016,20SEP2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,13DEC2016,13DEC2016,None,No,No,No,No,9,No,No
098-081,6003,3,elevated blood pressure,21.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),13DEC2016,13DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14MAR2017,14MAR2017,None,No,No,No,No,10,No,No
098-028,6001,1,Upper Respiratory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18MAR2016,18MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,24MAR2016,24MAR2016,None,No,No,No,No,2,No,No
098-028,6002,2,neck pain secondary to lifting heavy bookcase,21.0,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,31AUG2016,31AUG2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,04SEP2016,04SEP2016,None,No,No,No,No,9,No,No
098-028,6003,3,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10DEC2016,10DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,22DEC2016,22DEC2016,None,No,No,No,No,11,No,No
098-028,6004,4,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10JAN2017,10JAN2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,26JAN2017,26JAN2017,Medication,No,No,No,No,11,No,No
098-021,6001,1,puncture wound left foot,21.0,"Injury, poisoning and procedural complications",Wound,Wound,Non-site specific injuries NEC,Injuries NEC,07APR2016,07APR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14APR2016,14APR2016,Medication,No,No,No,No,3,No,No
098-021,6002,2,Vomiting,21.0,Gastrointestinal disorders,Vomiting,Vomiting,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,25APR2016,25APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,25APR2016,25APR2016,None,No,No,No,No,4,No,No
098-021,6003,3,Insomnia,21.0,Psychiatric disorders,Insomnia,Insomnia,Disturbances in initiating and maintaining sleep,Sleep disorders and disturbances,20APR2016,20APR2016,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,4,No,No
098-083,6001,1,headache,21.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,17APR2016,17APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17APR2016,17APR2016,Medication,No,No,No,No,3,No,No
098-083,6002,2,seasonal allergies,21.0,Immune system disorders,Seasonal allergy,Seasonal allergy,Atopic disorders,Allergic conditions,18APR2016,18APR2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,15JUL2016,15JUL2016,Medication,No,No,No,No,4,No,No
098-083,6003,3,"torn calf muscle, Left leg",21.0,"Injury, poisoning and procedural complications",Muscle rupture,Torn muscle,"Muscle, tendon and ligament injuries",Injuries NEC,31MAY2016,31MAY2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15JUL2016,15JUL2016,"Medication, Other",No,No,No,No,6,No,No
098-083,6004,4,seasonal allergies,21.0,Immune system disorders,Seasonal allergy,Seasonal allergy,Atopic disorders,Allergic conditions,03APR2017,03APR2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,JUN2017,15JUN2017,Medication,No,No,No,No,11,No,No
098-083,6005,5,oral ulcer,21.0,Gastrointestinal disorders,Mouth ulceration,Oral ulceration,Stomatitis and ulceration,Oral soft tissue conditions,JUN2017,15JUN2017,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,JUL2017,15JUL2017,Medication,No,No,No,No,12,No,No
098-008,6001,1,Versalgia (hangover),21.0,General disorders and administration site conditions,Hangover,Hangover,Feelings and sensations NEC,General system disorders NEC,04MAY2016,04MAY2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04MAY2016,04MAY2016,None,No,No,No,No,4,No,No
098-008,6002,2,hematuria,21.0,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,07JUL2016,07JUL2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,21SEP2016,21SEP2016,None,No,No,No,No,6,No,No
098-008,6003,3,Right hand impact injury-dorsal surface of 5th digit,21.0,"Injury, poisoning and procedural complications",Limb injury,Injury to finger NOS,Site specific injuries NEC,Injuries NEC,08JUL2016,08JUL2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01AUG2016,01AUG2016,None,No,No,No,No,7,No,No
098-008,6004,4,headache,21.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,14SEP2016,14SEP2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,14SEP2016,14SEP2016,None,No,No,No,No,9,No,No
098-005,6001,1,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,16JAN2017,16JAN2017,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,20JAN2017,20JAN2017,Medication,No,No,No,No,11,No,No
098-063,6001,1,Post Injection Vasovagal Episode,21.0,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,06APR2016,06APR2016,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,06APR2016,06APR2016,Other,No,No,No,No,2,No,No
098-063,6002,2,"injection site itching, left arm",21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,07APR2016,07APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,11APR2016,11APR2016,None,No,No,No,No,2,No,No
098-063,6003,3,erythematous ring on left 3rd. finger,21.0,Skin and subcutaneous tissue disorders,Rash erythematous,Erythematous rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,01OCT2016,01OCT2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,15NOV2016,15NOV2016,None,No,No,No,No,9,No,No
098-063,6004,4,pain radiating down left lower extremity,21.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Pain of lower extremities,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,11SEP2017,11SEP2017,Mild,Mild,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
098-098,6001,1,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06OCT2016,06OCT2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,16OCT2016,16OCT2016,Medication,No,No,No,No,8,No,No
098-041,6001,1,hypotension,21.0,Vascular disorders,Hypotension,Hypotension,Vascular hypotensive disorders,Decreased and nonspecific blood pressure disorders and shock,13OCT2015,13OCT2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,13OCT2015,13OCT2015,Other,No,No,No,No,2,No,No
098-018,6001,1,R ankle partial ligament tear,21.0,"Injury, poisoning and procedural complications",Ligament rupture,Ligament tear,"Muscle, tendon and ligament injuries",Injuries NEC,15DEC2015,15DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAR2016,15MAR2016,Other,No,No,No,No,7,No,No
098-018,6002,2,mononucleosis,21.0,Infections and infestations,Infectious mononucleosis,Mononucleosis infectious,Epstein-Barr viral infections,Viral infectious disorders,20JAN2016,20JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAR2016,15MAR2016,None,No,No,No,No,7,No,No
098-018,6004,4,Right ankle tendonitis,21.0,Musculoskeletal and connective tissue disorders,Tendonitis,Tendonitis,Tendon disorders,"Tendon, ligament and cartilage disorders",15DEC2015,15DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15MAR2016,15MAR2016,Other,No,No,No,No,7,No,No
098-024,6001,1,URI - upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,22DEC2015,22DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,26DEC2015,26DEC2015,Medication,No,No,No,No,6,No,No
098-024,6002,2,bilateral injection site pruritis,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,15JAN2016,15JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18JAN2016,18JAN2016,None,No,No,No,No,7,No,No
098-060,6001,1,proteinuria,21.0,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,09NOV2015,09NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,23NOV2015,23NOV2015,None,No,No,No,No,3,No,No
098-060,6002,2,cough,21.0,"Respiratory, thoracic and mediastinal disorders",Cough,Cough,Coughing and associated symptoms,Respiratory disorders NEC,01DEC2015,01DEC2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,15DEC2015,15DEC2015,None,No,No,No,No,5,No,No
098-060,6003,3,upper respiratory tract infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,11JAN2016,11JAN2016,Mild,Mild,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,20JAN2016,20JAN2016,None,No,No,No,No,6,No,No
098-060,6004,4,elevated creatine kinase,21.0,Investigations,Blood creatine phosphokinase increased,Creatine kinase increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,01FEB2016,01FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,17MAR2016,17MAR2016,None,No,No,No,No,7,No,No
098-060,6005,5,animal bite - right hand,21.0,"Injury, poisoning and procedural complications",Animal bite,Animal bite,Non-site specific injuries NEC,Injuries NEC,06FEB2016,06FEB2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,14MAR2016,14MAR2016,Medication,No,No,No,No,7,No,No
098-023,6001,1,left cheek mucosal blister,21.0,Gastrointestinal disorders,Oral mucosal blistering,Oral mucosal blistering,Oral soft tissue signs and symptoms,Oral soft tissue conditions,16NOV2015,16NOV2015,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,18NOV2015,18NOV2015,None,No,No,No,No,2,No,No
098-023,6002,2,very small amount of cloudy fluid from injection site,21.0,General disorders and administration site conditions,Injection site discharge,Injection site discharge,Injection site reactions,Administration site reactions,18NOV2015,18NOV2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,19NOV2015,19NOV2015,None,No,No,No,No,2,No,No
098-023,6003,3,pharyngitis,21.0,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,08FEB2016,08FEB2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03JUN2016,03JUN2016,None,No,No,No,No,6,No,No
098-023,6004,4,Asthma exacerbation,21.0,"Respiratory, thoracic and mediastinal disorders",Asthma,Exacerbation of asthma,Bronchospasm and obstruction,Bronchial disorders (excl neoplasms),20APR2016,20APR2016,Moderate,Moderate,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,23MAY2016,23MAY2016,Medication,No,No,No,No,8,No,No
098-059,6001,1,very small amount of purulent fluid from right arm injection site,21.0,General disorders and administration site conditions,Injection site discharge,Injection site discharge,Injection site reactions,Administration site reactions,13DEC2015,13DEC2015,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,14DEC2015,14DEC2015,None,No,No,No,No,4,No,No
098-059,6002,2,sinus infection,21.0,Infections and infestations,Sinusitis,Sinus infection,Upper respiratory tract infections,Infections - pathogen unspecified,28JAN2016,28JAN2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,19FEB2016,19FEB2016,Medication,No,No,No,No,6,No,No
098-061,6001,1,Itching at left injection site,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,13JAN2016,13JAN2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,18JAN2016,18JAN2016,None,No,No,No,No,4,No,No
098-061,6002,2,Itching at injection site; Left,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,10FEB2016,10FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,14FEB2016,14FEB2016,None,No,No,No,No,5,No,No
098-061,6003,3,Itching at injection site ; Right,21.0,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,10FEB2016,10FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,14FEB2016,14FEB2016,None,No,No,No,No,5,No,No
098-097,6001,1,upper respiratory infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,30JAN2016,30JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,02FEB2016,02FEB2016,Medication,No,No,No,No,3,No,No
098-043,6001,1,Left axillary adenopathy less than 1 cm,21.0,Blood and lymphatic system disorders,Lymphadenopathy,Axillary adenopathy,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",17MAR2016,17MAR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,27DEC2016,27DEC2016,None,No,No,No,No,6,No,No
098-043,6005,5,Rhabdomyolysis,21.0,Musculoskeletal and connective tissue disorders,Rhabdomyolysis,Rhabdomyolysis,Myopathies,Muscle disorders,13SEP2016,13SEP2016,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,27DEC2016,27DEC2016,Other,No,No,No,No,10,No,No
098-043,6006,6,Cocaine Abuse,21.0,Psychiatric disorders,Drug abuse,Cocaine abuse,Substance related and addictive disorders,Psychiatric disorders NEC,SEP2016,15SEP2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,APR2017,15APR2017,None,No,No,No,No,10.1,No,No
098-014,6001,1,Left Axillary Lymphadenopathy,21.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",29JUN2016,29JUN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,20OCT2016,20OCT2016,None,No,No,No,No,8,No,No
098-014,6002,2,Depression,21.0,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,01DEC2016,01DEC2016,Mild,Mild,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
098-062,6001,1,Hematuria,21.0,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,15FEB2016,15FEB2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,25FEB2016,25FEB2016,Other,No,No,No,No,3.1,No,No
098-062,6002,2,Left Axillary Lymphadenopathy.,21.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",20APR2016,20APR2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,06JUL2016,06JUL2016,None,No,No,No,No,6,No,No
098-090,6001,1,"Upper Respiratory Infection, Viral",21.0,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,18APR2016,18APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,01MAY2016,01MAY2016,Medication,No,No,No,No,6,No,No
098-090,6002,2,Travelers Diarrhea,21.0,Infections and infestations,Diarrhoea infectious,Traveller's diarrhea,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,02AUG2016,02AUG2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,04AUG2016,04AUG2016,Medication,No,No,No,No,8,No,No
098-090,6003,3,Increased Creatine Kinase,21.0,Investigations,Blood creatine phosphokinase increased,Creatine kinase increased,Skeletal and cardiac muscle analyses,Enzyme investigations NEC,26AUG2016,26AUG2016,Potentially life-threatening,Potentially life-threatening,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,31AUG2016,31AUG2016,None,No,No,No,No,9,No,No
098-079,6001,1,Pyelonephritis diagnosis,21.0,Infections and infestations,Pyelonephritis,Pyelonephritis,Urinary tract infections,Infections - pathogen unspecified,08FEB2016,08FEB2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,09FEB2016,09FEB2016,Medication,No,No,No,No,3,No,No
098-079,6002,2,Left axillary lymphadenopathy,21.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",23FEB2016,23FEB2016,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,14MAR2016,14MAR2016,None,No,No,No,No,4,No,No
098-079,6005,5,Periumbilical Abdominal pain,21.0,Gastrointestinal disorders,Abdominal pain,Periumbilical pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,27MAR2016,27MAR2016,Mild,Mild,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,22APR2016,22APR2016,Medication,No,No,No,No,6,No,No
098-079,6006,6,Cystitis,21.0,Infections and infestations,Cystitis,Cystitis,Urinary tract infections,Infections - pathogen unspecified,22MAY2016,22MAY2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01JUN2016,01JUN2016,Medication,No,No,No,No,8,No,No
098-079,6008,8,Colon Cancer,21.0,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Colon cancer,Colon cancer,Colorectal neoplasms malignant,Gastrointestinal neoplasms malignant and unspecified,24OCT2016,24OCT2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,17JAN2017,17JAN2017,Other,No,No,No,No,10.1,No,No
098-079,6009,9,Colorectal Surgery due to Colon Cancer,21.0,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Colon cancer,Colon cancer,Colorectal neoplasms malignant,Gastrointestinal neoplasms malignant and unspecified,17JAN2017,17JAN2017,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,24JAN2017,24JAN2017,New/Prolonged Hospitalization,Yes,Yes,Yes,Yes,12,No,No
098-079,6011,11,Aortic Thrombus,21.0,Vascular disorders,Aortic thrombosis,Aortic thrombosis,Aortic embolism and thrombosis,Embolism and thrombosis,09AUG2017,09AUG2017,Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,,,"Medication, New/Prolonged Hospitalization",Yes,Yes,Yes,Yes,12,No,No
098-070,6001,1,Heartburn,21.0,Gastrointestinal disorders,Dyspepsia,Heartburn,Dyspeptic signs and symptoms,Gastrointestinal signs and symptoms,29JAN2016,29JAN2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,22FEB2016,22FEB2016,Medication,No,No,No,No,3,No,No
098-070,6002,2,Wrist pain Bilateral,21.0,Musculoskeletal and connective tissue disorders,Arthralgia,Wrist pain,Joint related signs and symptoms,Joint disorders,04MAR2016,04MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31MAR2016,31MAR2016,Medication,No,No,No,No,5,No,No
098-070,6003,3,Shoulder pain bilateral.,21.0,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,04MAR2016,04MAR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,31MAR2016,31MAR2016,Medication,No,No,No,No,5,No,No
098-067,6001,1,Elevated Blood Pressure.,21.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),25MAR2016,25MAR2016,Moderate,Moderate,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,28MAR2016,28MAR2016,None,No,No,No,No,4,No,No
098-067,6003,3,Elevated Creatinine,21.0,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,10MAY2016,10MAY2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,01JUL2016,01JUL2016,None,No,No,No,No,7,No,No
098-006,6002,2,Accidental Overdose,21.0,"Injury, poisoning and procedural complications",Accidental overdose,Accidental overdose,Product administration errors and issues,Medication errors and other product use errors and issues,18JUN2016,18JUN2016,Death,Death,Not Related,Not Related,Held,Held,Death,Death,18JUN2016,18JUN2016,None,Yes,Yes,Yes,Yes,6,No,No
098-094,6001,1,acute viral gastroenteritis,21.0,Infections and infestations,Gastroenteritis viral,Viral gastroenteritis,Viral infections NEC,Viral infectious disorders,02APR2016,02APR2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,03APR2016,03APR2016,None,No,No,No,No,3,No,No
098-094,6002,2,Upper Respitory Infection,21.0,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05MAY2016,05MAY2016,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,11MAY2016,11MAY2016,Medication,No,No,No,No,5,No,No
098-049,6001,1,Elevated blood pressure,21.0,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),01JUL2016,01JUL2016,Mild,Mild,Not Related,Not Related,Reduced,Reduced,Resolved,Resolved,08JUL2016,08JUL2016,Other,No,No,No,No,4,No,No
098-049,6002,2,Right Axillary Lymphadenopathy,21.0,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",08JUL2016,08JUL2016,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,19AUG2016,19AUG2016,None,No,No,No,No,4,No,No
098-049,6003,3,Elevated blood pressure.,21.0,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),06DEC2016,06DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,21DEC2016,21DEC2016,Other,No,No,No,No,8,No,No
098-049,6004,4,Chest Pain,21.0,General disorders and administration site conditions,Chest pain,Chest pain,Pain and discomfort NEC,General system disorders NEC,15DEC2016,15DEC2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16DEC2016,16DEC2016,"Medication, Other",No,No,No,No,8,No,No
098-049,6005,5,Pain in Left upper extremity,21.0,Musculoskeletal and connective tissue disorders,Pain in extremity,Painful L arm,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,15DEC2016,15DEC2016,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16DEC2016,16DEC2016,"Medication, Other",No,No,No,No,9,No,No
098-049,6006,6,Headache,21.0,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,15DEC2016,15DEC2016,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,16DEC2016,16DEC2016,Other,No,No,No,No,9,No,No