pub_id,visit,AEpagenum,AEdiag,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
105-092,6001,1,Sinusitis,Infections and infestations,Sinusitis,Sinusitis,Upper respiratory tract infections,Infections - pathogen unspecified,16FEB2015,16FEB2015,1,Mild,2,Not Related,4,N/A,2,Resolved,21FEB2015,21FEB2015,None,2,No,2,No,9,2,No
105-198,6001,1,NAUSEA,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,21SEP2014,21SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,22SEP2014,22SEP2014,None,2,No,2,No,5,2,No
105-198,6002,2,VERTIGO,Ear and labyrinth disorders,Vertigo,Vertigo,Inner ear signs and symptoms,Inner ear and VIIIth cranial nerve disorders,11NOV2014,11NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,12NOV2014,12NOV2014,Medication,2,No,2,No,6,2,No
105-198,6003,3,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,11NOV2014,11NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,16NOV2014,16NOV2014,Medication,2,No,2,No,6,2,No
105-198,6004,4,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20JAN2015,20JAN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,27JAN2015,27JAN2015,Medication,2,No,2,No,9,2,No
105-134,6001,1,VIRAL ILLNESS,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,03JAN2015,03JAN2015,2,Moderate,2,Not Related,1,No change,2,Resolved,06JAN2015,06JAN2015,Medication,2,No,2,No,8,2,No
105-134,6002,2,POISON IVY (RASH),Skin and subcutaneous tissue disorders,Dermatitis contact,Poison ivy rash,Dermatitis and eczema,Epidermal and dermal conditions,24APR2015,24APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,08MAY2015,08MAY2015,Medication,2,No,2,No,10,2,No
105-153,6001,1,PHARYNGITIS,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,26OCT2014,26OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,30OCT2014,30OCT2014,None,2,No,2,No,6,2,No
105-153,6002,2,NAUSEA,Gastrointestinal disorders,Nausea,Nausea,Nausea and vomiting symptoms,Gastrointestinal signs and symptoms,26OCT2014,26OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,30OCT2014,30OCT2014,None,2,No,2,No,6,2,No
105-153,6003,3,LEFT OTITIS MEDIA,Infections and infestations,Otitis media,Otitis media,Ear infections,Infections - pathogen unspecified,29OCT2014,29OCT2014,2,Moderate,2,Not Related,1,No change,2,Resolved,06NOV2014,06NOV2014,None,2,No,2,No,6,2,No
105-153,6004,4,BILATERAL CONJUNCTIVITIS,Infections and infestations,Conjunctivitis,Conjunctivitis,Eye and eyelid infections,Infections - pathogen unspecified,01NOV2014,01NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,03NOV2014,03NOV2014,Medication,2,No,2,No,6,2,No
105-153,6005,5,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06APR2015,06APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,15APR2015,15APR2015,None,2,No,2,No,10,2,No
105-262,6001,1,BRUISING AT INJECTION SITE RIGHT DELTOID,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,11SEP2014,11SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,14SEP2014,14SEP2014,None,2,No,2,No,4,2,No
105-211,6001,1,BACK PAIN-MID LUMBAR,Musculoskeletal and connective tissue disorders,Back pain,Lumbar pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,24AUG2014,24AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,24AUG2014,24AUG2014,None,2,No,2,No,2,2,No
105-211,6002,2,FLU LIKE ILLNESS,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,05SEP2014,05SEP2014,2,Moderate,2,Not Related,1,No change,2,Resolved,07SEP2014,07SEP2014,Medication,2,No,2,No,3,2,No
105-047,6001,1,DECREASED PLATELETS,Investigations,Platelet count decreased,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),09OCT2014,09OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,16OCT2014,16OCT2014,Other,2,No,2,No,5,2,No
105-047,6002,2,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,07NOV2014,07NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,12NOV2014,12NOV2014,Medication,2,No,2,No,6,2,No
105-056,6001,1,NASAL CONGESTION,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),25AUG2014,25AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,27AUG2014,27AUG2014,Medication,2,No,2,No,3,2,No
105-056,6002,2,GASTROENTERITIS,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,23DEC2014,23DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,26DEC2014,26DEC2014,None,2,No,2,No,8,2,No
105-056,6003,3,VIRAL ILLNESS,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,30MAR2015,30MAR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,03APR2015,03APR2015,Medication,2,No,2,No,10,2,No
105-109,6001,1,VIRAL ILLNESS,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,10JAN2015,10JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,12JAN2015,12JAN2015,Medication,2,No,2,No,8,2,No
105-105,6001,1,VASO-VAGAL EPISODE RELATED TO BLOOD DRAW,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,02OCT2014,02OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,02OCT2014,02OCT2014,None,2,No,2,No,2,2,No
105-105,6002,2,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,12APR2015,12APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,15APR2015,15APR2015,Medication,2,No,2,No,9,2,No
105-105,6003,3,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,23SEP2015,23SEP2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-073,6001,1,RIGHT ANKLE SPRAIN,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,01DEC2014,01DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,20DEC2014,20DEC2014,None,2,No,2,No,6,2,No
105-073,6002,2,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06FEB2015,06FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,11FEB2015,11FEB2015,None,2,No,2,No,8,2,No
105-147,6001,1,BILATERAL FLUID IN EARS,Ear and labyrinth disorders,Middle ear effusion,Fluid in middle ear,Middle ear disorders NEC,Middle ear disorders (excl congenital),01OCT2014,01OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,08JAN2015,08JAN2015,None,2,No,2,No,2.1,2,No
105-138,6001,1,SORE THROAT,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory disorders NEC,12OCT2014,12OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,13OCT2014,13OCT2014,None,2,No,2,No,2,2,No
105-138,6002,2,ABRASION LT LOWER LEG 6.0cm X 3.0cm,"Injury, poisoning and procedural complications",Skin abrasion,Skin abrasion,Skin injuries NEC,Injuries NEC,04SEP2015,04SEP2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-138,6003,3,LEFT KNEE SPRAIN,"Injury, poisoning and procedural complications",Ligament sprain,Knee sprain,"Muscle, tendon and ligament injuries",Injuries NEC,18SEP2015,18SEP2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-207,6001,1,LEFT PLANTAR FIBROMATOSIS,Musculoskeletal and connective tissue disorders,Plantar fascial fibromatosis,Plantar fascial fibromatosis,Musculoskeletal and connective tissue infections and inflammations NEC,Musculoskeletal and connective tissue disorders NEC,18OCT2014,18OCT2014,2,Moderate,2,Not Related,1,No change,2,Resolved,01DEC2014,01DEC2014,"Medication, Other",2,No,2,No,2,2,No
105-207,6002,2,EXACERBATION OF RAYNAUDS PHENOMENON,Vascular disorders,Raynaud's phenomenon,Raynaud's phenomenon,"Peripheral vasoconstriction, necrosis and vascular insufficiency","Arteriosclerosis, stenosis, vascular insufficiency and necrosis",10DEC2014,10DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,FEB2015,15FEB2015,Medication,2,No,2,No,5.1,2,No
105-207,6003,3,LOW HEMOGLOBIN,Investigations,Haemoglobin decreased,Hemoglobin low,Red blood cell analyses,Haematology investigations (incl blood groups),27APR2015,27APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,24JUL2015,24JUL2015,None,2,No,2,No,9,2,No
105-097,6001,1,VASOVAGAL REACTION R/T BLOOD DRAW,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,16OCT2014,16OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,16OCT2014,16OCT2014,None,2,No,2,No,2,2,No
105-097,6002,2,FLU LIKE ILLNESS,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,28MAR2015,28MAR2015,2,Moderate,2,Not Related,1,No change,2,Resolved,01APR2015,01APR2015,Medication,2,No,2,No,8,2,No
105-097,6004,4,PYROSIS,Gastrointestinal disorders,Dyspepsia,Pyrosis,Dyspeptic signs and symptoms,Gastrointestinal signs and symptoms,20FEB2015,20FEB2015,1,Mild,2,Not Related,4,N/A,2,Resolved,27APR2015,27APR2015,Medication,2,No,2,No,9,2,No
105-097,6005,5,DECREASED HEMOGLOBIN,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),20APR2015,20APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,05AUG2015,05AUG2015,None,2,No,2,No,9,2,No
105-097,6006,6,CONCUSSION,"Injury, poisoning and procedural complications",Concussion,Concussion,Cerebral injuries NEC,Injuries NEC,15JUL2015,15JUL2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,29JUL2015,29JUL2015,None,2,No,2,No,10.1,2,No
105-200,6001,1,EXACERBATION OF PANIC ATTACKS,Psychiatric disorders,Panic attack,Panic attacks,Panic attacks and disorders,Anxiety disorders and symptoms,15NOV2014,15NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,15NOV2014,15NOV2014,Other,2,No,2,No,4,2,No
105-200,6002,2,Decreased hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),02DEC2014,02DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,24JUN2015,24JUN2015,"Medication, Other",2,No,2,No,5,2,No
105-200,6003,3,DECREASED NEUTROPHILS,Investigations,Neutrophil count decreased,Neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),15JAN2015,15JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,19MAR2015,19MAR2015,None,2,No,2,No,6,2,No
105-165,6001,1,EXACERBATION OF MIGRAINE HEADACHES,Nervous system disorders,Migraine,Migraine headache,Migraine headaches,Headaches,19NOV2014,19NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,19NOV2014,19NOV2014,Medication,2,No,2,No,4,2,No
105-165,6002,2,URINARY TRACT INFECTION,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,06NOV2014,06NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,30NOV2014,30NOV2014,Medication,2,No,2,No,3,2,No
105-165,6003,3,GASTROENTERITIS,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,09JAN2015,09JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,10JAN2015,10JAN2015,None,2,No,2,No,6,2,No
105-165,6004,4,DEPRESSION,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,FEB2015,15FEB2015,1,Mild,2,Not Related,1,No change,5,Continuing at end of study participation,,,Other,2,No,2,No,8,2,No
105-165,6005,5,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,21MAR2015,21MAR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,23MAR2015,23MAR2015,Medication,2,No,2,No,8,2,No
105-165,6006,6,urinary tract infection,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,01APR2015,01APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,06MAY2015,06MAY2015,Medication,2,No,2,No,9,2,No
105-291,6001,1,BRUISING AT INJECTION SITE RIGHT DELTOID 2 CM X 2 CM,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,11NOV2014,11NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,05DEC2014,05DEC2014,None,2,No,2,No,2,2,No
105-291,6002,2,BRUISING AT INJECTION SITE LEFT DELTIOD 1.5 cm X 1.5 cm,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,10DEC2014,10DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,21DEC2014,21DEC2014,None,2,No,2,No,4,2,No
105-291,6003,3,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,23DEC2014,23DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,05JAN2015,05JAN2015,Medication,2,No,2,No,6,2,No
105-291,6004,4,bruising at left anticubital 2.5cm x 2.5cm RELATED TO PHLEBOTOMY PROCEDURE -SA,General disorders and administration site conditions,Vessel puncture site bruise,Venipuncture site bruise,Administration site reactions NEC,Administration site reactions,28JAN2015,28JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,06FEB2015,06FEB2015,None,2,No,2,No,6,2,No
105-291,6005,5,bruising at injection site. right deltoid 1cm x 1cm,General disorders and administration site conditions,Injection site bruising,Injection site bruising,Injection site reactions,Administration site reactions,29JAN2015,29JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,20FEB2015,20FEB2015,None,2,No,2,No,6,2,No
105-291,6007,7,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,12APR2015,12APR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,21APR2015,21APR2015,Medication,2,No,2,No,9,2,No
105-248,6001,1,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04DEC2014,04DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,28DEC2014,28DEC2014,None,2,No,2,No,4,2,No
105-248,6002,2,Insect Bite CELLULITIS RIGHT CALF,"Injury, poisoning and procedural complications",Arthropod bite,Insect bite NOS,Non-site specific injuries NEC,Injuries NEC,11JUL2015,11JUL2015,1,Mild,2,Not Related,4,N/A,2,Resolved,21JUL2015,21JUL2015,Medication,2,No,2,No,10,2,No
105-298,6001,1,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,31DEC2014,31DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,13JAN2015,13JAN2015,Medication,2,No,2,No,6,2,No
105-272,6001,1,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,14FEB2015,14FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,22FEB2015,22FEB2015,None,2,No,2,No,6,2,No
105-017,6001,1,URI,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,19DEC2014,19DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,04JAN2015,04JAN2015,Medication,2,No,2,No,8,2,No
105-086,6001,1,GI Illness,Infections and infestations,Gastrointestinal infection,GI infection,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,19OCT2014,19OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,21OCT2014,21OCT2014,None,2,No,2,No,6,2,No
105-019,6001,1,diarrhea,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,17AUG2014,17AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,17AUG2014,17AUG2014,None,2,No,2,No,2,2,No
105-019,6002,2,increased alt level,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,30APR2015,30APR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,19MAY2015,19MAY2015,None,2,No,2,No,10,2,No
105-292,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,01SEP2014,01SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,02SEP2014,02SEP2014,Medication,2,No,2,No,3,2,No
105-292,6002,2,Pharyngitis,Infections and infestations,Pharyngitis,Pharyngitis,Upper respiratory tract infections,Infections - pathogen unspecified,30OCT2014,30OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,06NOV2014,06NOV2014,Medication,2,No,2,No,6,2,No
105-292,6003,3,left index finger infection,Infections and infestations,Localised infection,Infected finger,Infections NEC,Infections - pathogen unspecified,31DEC2014,31DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,09JAN2015,09JAN2015,Medication,2,No,2,No,8,2,No
105-121,6001,1,rash (face/neck),Skin and subcutaneous tissue disorders,Rash,Skin rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,02SEP2014,02SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,09SEP2014,09SEP2014,None,2,No,2,No,3,2,No
105-121,6002,2,decrease hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),02SEP2014,02SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,02OCT2014,02OCT2014,None,2,No,2,No,3,2,No
105-121,6003,3,viral upper respiratory infection,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,18NOV2014,18NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,02DEC2014,02DEC2014,Medication,2,No,2,No,7,2,No
105-121,6004,4,URI,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,09JAN2015,09JAN2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,25JAN2015,25JAN2015,Medication,2,No,2,No,9,2,No
105-121,6005,5,decreased hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),21JAN2015,21JAN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,20MAY2015,20MAY2015,None,2,No,2,No,9,2,No
105-250,6001,1,Anxiety,Psychiatric disorders,Anxiety,Anxiety,Anxiety symptoms,Anxiety disorders and symptoms,10JAN2015,10JAN2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,8,2,No
105-172,6001,1,increased ALT,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,25NOV2014,25NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,12JAN2015,12JAN2015,None,2,No,2,No,7,2,No
105-087,6001,1,left knee arthritis pain,Musculoskeletal and connective tissue disorders,Arthralgia,Arthritic pains,Joint related signs and symptoms,Joint disorders,15NOV2014,15NOV2014,1,Mild,2,Not Related,1,No change,5,Continuing at end of study participation,,,Medication,2,No,2,No,6,2,No
105-087,6002,2,Right Tibia fracture,"Injury, poisoning and procedural complications",Tibia fracture,Tibia fracture,Limb fractures and dislocations,Bone and joint injuries,29JAN2015,29JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,15MAY2015,15MAY2015,Other,2,No,2,No,8,2,No
105-087,6003,3,Neuropathic pain due to bulging disk,Musculoskeletal and connective tissue disorders,Intervertebral disc protrusion,Intervertebral disc bulging,Intervertebral disc disorders NEC,Musculoskeletal and connective tissue deformities (incl intervertebral disc disorders),SEP2014,15SEP2014,1,Mild,2,Not Related,4,N/A,2,Resolved,05MAY2015,05MAY2015,"Medication, Other",2,No,2,No,9,2,No
105-087,6004,4,meniscus tear rt. knee,"Injury, poisoning and procedural complications",Meniscus injury,Meniscus tear,Bone and joint injuries NEC,Bone and joint injuries,10AUG2015,10AUG2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,"Medication, Other",2,No,2,No,11,2,No
105-141,6001,1,sinus infection,Infections and infestations,Sinusitis,Sinus infection,Upper respiratory tract infections,Infections - pathogen unspecified,02DEC2014,02DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,08DEC2014,08DEC2014,Medication,2,No,2,No,6,2,No
105-141,6003,3,suspected gastrointestinal bleed,Gastrointestinal disorders,Gastrointestinal haemorrhage,Gastrointestinal bleed,Non-site specific gastrointestinal haemorrhages,Gastrointestinal haemorrhages NEC,31JUL2015,31JUL2015,3,Severe,2,Not Related,4,N/A,2,Resolved,04AUG2015,04AUG2015,"Medication, New/Prolonged Hospitalization",1,Yes,1,Yes,11,2,No
105-141,6004,4,allergic reaction (shellfish allergy),Immune system disorders,Food allergy,Shellfish allergy,"Allergies to foods, food additives, drugs and other chemicals",Allergic conditions,24JUL2015,24JUL2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,24JUL2015,24JUL2015,Medication,2,No,2,No,11,2,No
105-141,6005,5,suspected gastrointestinal bleed,Gastrointestinal disorders,Gastrointestinal haemorrhage,Gastrointestinal bleed,Non-site specific gastrointestinal haemorrhages,Gastrointestinal haemorrhages NEC,25JUL2015,25JUL2015,2,Moderate,2,Not Related,4,N/A,4,Severity/frequency increased,31JUL2015,31JUL2015,None,2,No,2,No,11,2,No
105-276,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,13DEC2014,13DEC2014,1,Mild,2,Not Related,2,Held,2,Resolved,15DEC2014,15DEC2014,Medication,2,No,2,No,6,2,No
105-245,6001,1,productive cough,"Respiratory, thoracic and mediastinal disorders",Productive cough,Productive cough,Coughing and associated symptoms,Respiratory disorders NEC,09DEC2014,09DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,28DEC2014,28DEC2014,Medication,2,No,2,No,6,2,No
105-245,6002,2,Influenza,Infections and infestations,Influenza,Influenza,Influenza viral infections,Viral infectious disorders,21DEC2014,21DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,27DEC2014,27DEC2014,Medication,2,No,2,No,7,2,No
105-245,6003,3,strep pharyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,16MAY2015,16MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,22MAY2015,22MAY2015,Medication,2,No,2,No,10,2,No
105-245,6004,4,sinus cold (URI),Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,07SEP2015,07SEP2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-070,6001,1,hangover,General disorders and administration site conditions,Hangover,Hangover,Feelings and sensations NEC,General system disorders NEC,08NOV2014,08NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,08NOV2014,08NOV2014,Medication,2,No,2,No,3,2,No
105-070,6002,2,uri,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,18NOV2014,18NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,21NOV2014,21NOV2014,Medication,2,No,2,No,4,2,No
105-070,6003,3,Presumable viral infection,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,27DEC2014,27DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,02JAN2015,02JAN2015,Medication,2,No,2,No,6,2,No
105-070,6004,4,Hives,Skin and subcutaneous tissue disorders,Urticaria,Hives,Urticarias,Angioedema and urticaria,19JAN2015,19JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,22JAN2015,22JAN2015,Medication,2,No,2,No,6,2,No
105-070,6005,5,(L) knee pain,Musculoskeletal and connective tissue disorders,Arthralgia,Knee pain,Joint related signs and symptoms,Joint disorders,14FEB2015,14FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,14FEB2015,14FEB2015,Medication,2,No,2,No,7,2,No
105-052,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,01JAN2015,01JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,15JAN2015,15JAN2015,None,2,No,2,No,4,2,No
105-082,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05DEC2014,05DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,09DEC2014,09DEC2014,Medication,2,No,2,No,2,2,No
105-095,6001,1,R. Shoulder dislocation,"Injury, poisoning and procedural complications",Joint dislocation,Shoulder dislocation,Fractures and dislocations NEC,Bone and joint injuries,18FEB2015,18FEB2015,2,Moderate,2,Not Related,1,No change,2,Resolved,14APR2015,14APR2015,Medication,2,No,2,No,7,2,No
105-095,6002,2,Tooth abscess,Infections and infestations,Tooth abscess,Tooth abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,31MAR2015,31MAR2015,1,Mild,2,Not Related,1,No change,2,Resolved,14APR2015,14APR2015,Medication,2,No,2,No,8,2,No
105-241,6001,1,elevated blood pressure/,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),23JAN2015,23JAN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,15APR2015,15APR2015,None,2,No,2,No,9,2,No
105-241,6002,2,"upper respiratory infection, viral",Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,04JUL2015,04JUL2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-252,6001,1,fatigue,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,04AUG2014,04AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,07AUG2014,07AUG2014,None,2,No,2,No,3,2,No
105-252,6002,2,Elevated blood pressure,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),29OCT2014,29OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,12NOV2014,12NOV2014,None,2,No,2,No,6,2,No
105-252,6003,3,elevated alt,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,12NOV2014,12NOV2014,1,Mild,1,Related,1,No change,2,Resolved,16DEC2014,16DEC2014,None,2,No,2,No,7,2,No
105-252,6004,4,dry lips,Gastrointestinal disorders,Lip dry,Dry lips,Oral dryness and saliva altered,Salivary gland conditions,MAY2015,15MAY2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Other,2,No,2,No,11,2,No
105-128,6001,1,viral illness,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,22AUG2014,22AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,25AUG2014,25AUG2014,None,2,No,2,No,4,2,No
105-128,6002,2,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,17NOV2014,17NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,20NOV2014,20NOV2014,Medication,2,No,2,No,8,2,No
105-128,6003,3,UPPER RESPIRATORY INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,29DEC2014,29DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,31DEC2014,31DEC2014,Medication,2,No,2,No,8,2,No
105-128,6004,4,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,07FEB2015,07FEB2015,1,Mild,2,Not Related,4,N/A,2,Resolved,10FEB2015,10FEB2015,Medication,2,No,2,No,9,2,No
105-128,6005,5,Maculopapular Rash bilateral wrists,Skin and subcutaneous tissue disorders,Rash maculo-papular,Maculopapular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,03FEB2015,03FEB2015,1,Mild,2,Not Related,4,N/A,2,Resolved,05FEB2015,05FEB2015,Medication,2,No,2,No,9,2,No
105-208,6001,1,elevated blood pressure,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),28OCT2014,28OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,07JAN2015,07JAN2015,None,2,No,2,No,6,2,No
105-256,6001,1,elevated ALT,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,13AUG2014,13AUG2014,1,Mild,2,Not Related,1,No change,2,Resolved,28AUG2014,28AUG2014,None,2,No,2,No,3,2,No
105-256,6002,2,hypertension,Vascular disorders,Hypertension,Hypertension,Vascular hypertensive disorders NEC,Vascular hypertensive disorders,13AUG2014,13AUG2014,1,Mild,2,Not Related,1,No change,5,Continuing at end of study participation,,,Medication,2,No,2,No,3,2,No
105-256,6003,3,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,11NOV2014,11NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,15NOV2014,15NOV2014,Medication,2,No,2,No,7,2,No
105-256,6005,5,low vitamin d,Investigations,Vitamin D decreased,Vitamin D decreased,Vitamin analyses,"Metabolic, nutritional and blood gas investigations",21MAY2015,21MAY2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-256,6006,6,strep throat,Infections and infestations,Pharyngitis streptococcal,Streptococcal sore throat,Streptococcal infections,Bacterial infectious disorders,24JUN2015,24JUN2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,05JUL2015,05JUL2015,Medication,2,No,2,No,11,2,No
105-256,6007,7,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,22JUL2015,22JUL2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-187,6001,1,vasovagal reaction,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,30JUL2014,30JUL2014,1,Mild,2,Not Related,1,No change,2,Resolved,30JUL2014,30JUL2014,None,2,No,2,No,2,2,No
105-187,6002,2,Urinary urgency,Renal and urinary disorders,Micturition urgency,Urinary urgency,Bladder and urethral symptoms,Urinary tract signs and symptoms,14JAN2015,14JAN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,15APR2015,15APR2015,Medication,2,No,2,No,9,2,No
105-174,6001,1,fatigue,General disorders and administration site conditions,Fatigue,Fatigue,Asthenic conditions,General system disorders NEC,30AUG2014,30AUG2014,1,Mild,1,Related,1,No change,2,Resolved,30AUG2014,30AUG2014,None,2,No,2,No,2,2,No
105-174,6002,2,pain right upper arm (at injection site & shoulder to elbow),General disorders and administration site conditions,Injection site pain,Pain injection site,Injection site reactions,Administration site reactions,30AUG2014,30AUG2014,1,Mild,1,Related,1,No change,2,Resolved,30AUG2014,30AUG2014,None,2,No,2,No,2,2,No
105-174,6003,3,myalgias secondary to motor vehicle accident,Musculoskeletal and connective tissue disorders,Myalgia,Myalgia,Muscle pains,Muscle disorders,14DEC2014,14DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,15JAN2015,15JAN2015,Medication,2,No,2,No,7,2,No
105-174,6004,4,left lower lip laceration secondary to motor vehicle accident,"Injury, poisoning and procedural complications",Lip injury,Lip laceration,Site specific injuries NEC,Injuries NEC,14DEC2014,14DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,16DEC2014,16DEC2014,Medication,2,No,2,No,7,2,No
105-115,6001,1,low hemoglobin,Investigations,Haemoglobin decreased,Hemoglobin low,Red blood cell analyses,Haematology investigations (incl blood groups),12NOV2014,12NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,03DEC2014,03DEC2014,"Medication, Other",2,No,2,No,7,2,No
105-115,6002,2,Right shoulder pain/dislocation,"Injury, poisoning and procedural complications",Joint dislocation,Shoulder dislocation,Fractures and dislocations NEC,Bone and joint injuries,15DEC2014,15DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,16JAN2015,16JAN2015,None,2,No,2,No,8,2,No
105-115,6003,3,elevated alt,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,05MAY2015,05MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,14MAY2015,14MAY2015,None,2,No,2,No,10,2,No
105-115,6004,4,right upper quadrant pain - intermittent,Gastrointestinal disorders,Abdominal pain upper,Right upper quadrant pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,15APR2015,15APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,10MAY2015,10MAY2015,None,2,No,2,No,10,2,No
105-237,6001,1,gastroenteritis,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,28SEP2014,28SEP2014,2,Moderate,2,Not Related,1,No change,2,Resolved,01OCT2014,01OCT2014,Medication,2,No,2,No,3,2,No
105-237,6002,2,Elevated blood pressure,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),02OCT2014,02OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,16APR2015,16APR2015,Other,2,No,2,No,3,2,No
105-237,6003,3,Sinus infection,Infections and infestations,Sinusitis,Sinus infection,Upper respiratory tract infections,Infections - pathogen unspecified,19NOV2014,19NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,25NOV2014,25NOV2014,Medication,2,No,2,No,6,2,No
105-237,6004,4,Upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24MAR2015,24MAR2015,1,Mild,2,Not Related,1,No change,2,Resolved,30MAR2015,30MAR2015,Medication,2,No,2,No,8,2,No
105-237,6005,5,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05APR2015,05APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,18APR2015,18APR2015,Medication,2,No,2,No,9,2,No
105-237,6006,6,elevated blood pressure,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),23JUN2015,23JUN2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,10,2,No
105-182,6002,2,elevated alt,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,02OCT2014,02OCT2014,1,Mild,1,Related,1,No change,2,Resolved,09OCT2014,09OCT2014,None,2,No,2,No,3,2,No
105-182,6003,3,left lower quadrant pain,Gastrointestinal disorders,Abdominal pain lower,Left lower quadrant pain,Gastrointestinal and abdominal pains (excl oral and throat),Gastrointestinal signs and symptoms,07OCT2014,07OCT2014,2,Moderate,2,Not Related,1,No change,5,Continuing at end of study participation,,,Other,2,No,2,No,4,2,No
105-182,6004,4,Pruritis at injection site (right),General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,24DEC2014,24DEC2014,1,Mild,1,Related,1,No change,2,Resolved,27DEC2014,27DEC2014,None,2,No,2,No,6,2,No
105-182,6005,5,pruritis at right injection site,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,11MAR2015,11MAR2015,1,Mild,1,Related,4,N/A,2,Resolved,13MAR2015,13MAR2015,None,2,No,2,No,8,2,No
105-182,6006,6,skin infection,Infections and infestations,Skin infection,Skin infection,Skin structures and soft tissue infections,Infections - pathogen unspecified,17AUG2015,17AUG2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-182,6007,7,"breast mass, left breast",Reproductive system and breast disorders,Breast mass,Breast mass,Breast disorders NEC,Breast disorders,24AUG2015,24AUG2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-127,6001,1,Fingernail of Right fifth digit injury r/t trauma,"Injury, poisoning and procedural complications",Nail injury,Nail injury,Skin injuries NEC,Injuries NEC,03OCT2014,03OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,19OCT2014,19OCT2014,None,2,No,2,No,6,2,No
105-127,6002,2,BRONCHITIS,Infections and infestations,Bronchitis,Bronchitis,Lower respiratory tract and lung infections,Infections - pathogen unspecified,10DEC2014,10DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,22DEC2014,22DEC2014,Medication,2,No,2,No,8,2,No
105-127,6003,3,"bronchitis, viral",Infections and infestations,Bronchitis viral,Bronchitis viral,Viral infections NEC,Viral infectious disorders,10APR2015,10APR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,26APR2015,26APR2015,Medication,2,No,2,No,10,2,No
105-127,6004,4,laceration of frontal region of scalp due to trauma,"Injury, poisoning and procedural complications",Laceration,Scalp laceration,Skin injuries NEC,Injuries NEC,22JUN2015,22JUN2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,02JUL2015,02JUL2015,"Medication, Procedure/Surgery",2,No,2,No,11,2,No
105-041,6001,1,upper back hematoma,Vascular disorders,Haematoma,Hematoma,Haemorrhages NEC,Vascular haemorrhagic disorders,20SEP2014,20SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,08OCT2014,08OCT2014,None,2,No,2,No,3,2,No
105-041,6002,2,diarrhea,Infections and infestations,Diarrhoea infectious,Infectious diarrhea,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,28NOV2014,28NOV2014,3,Severe,2,Not Related,1,No change,2,Resolved,28NOV2014,28NOV2014,Medication,2,No,2,No,6,2,No
105-041,6004,4,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08DEC2014,08DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,20DEC2014,20DEC2014,Medication,2,No,2,No,6,2,No
105-041,6005,5,left shoulder pain due to injury,"Injury, poisoning and procedural complications",Joint injury,Injury to shoulder NOS,Bone and joint injuries NEC,Bone and joint injuries,21DEC2014,21DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,MAR2015,15MAR2015,None,2,No,2,No,7,2,No
105-041,6006,6,left elbow pain,Musculoskeletal and connective tissue disorders,Arthralgia,Pain in elbow,Joint related signs and symptoms,Joint disorders,JUL2015,15JUL2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,AUG2015,15AUG2015,None,2,No,2,No,11,2,No
105-271,6001,1,tinea pedis between 4th & 5th toes of left foot,Infections and infestations,Tinea pedis,Tinea pedis,Tinea infections,Fungal infectious disorders,18SEP2014,18SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,31JAN2015,31JAN2015,Medication,2,No,2,No,3,2,No
105-271,6002,2,Pruritis of chin and neck,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,22OCT2014,22OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,14FEB2015,14FEB2015,Medication,2,No,2,No,5,2,No
105-271,6003,3,allergic rhinitis,"Respiratory, thoracic and mediastinal disorders",Rhinitis allergic,Allergic rhinitis,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),OCT2014,15OCT2014,2,Moderate,2,Not Related,1,No change,2,Resolved,14FEB2015,14FEB2015,Medication,2,No,2,No,6,2,No
105-271,6004,4,plantar fasciitis,Musculoskeletal and connective tissue disorders,Plantar fasciitis,Plantar fasciitis,Musculoskeletal and connective tissue infections and inflammations NEC,Musculoskeletal and connective tissue disorders NEC,03JUN2015,03JUN2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-180,6001,1,"upper respiratory infection, viral",Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,10NOV2014,10NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,18NOV2014,18NOV2014,Medication,2,No,2,No,5,2,No
105-180,6002,2,"Arthralgias in hands, arms, hips, feet",Musculoskeletal and connective tissue disorders,Arthralgia,Arthralgia,Joint related signs and symptoms,Joint disorders,28NOV2014,28NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,11DEC2014,11DEC2014,None,2,No,2,No,6,2,No
105-180,6003,3,anxiety,Psychiatric disorders,Anxiety,Anxiety,Anxiety symptoms,Anxiety disorders and symptoms,19JAN2015,19JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,FEB2015,15FEB2015,None,2,No,2,No,7,2,No
105-180,6004,4,sexual dysfunction,Reproductive system and breast disorders,Sexual dysfunction,Sexual dysfunction,Sexual function and fertility disorders NEC,Sexual function and fertility disorders,FEB2015,15FEB2015,2,Moderate,2,Not Related,1,No change,5,Continuing at end of study participation,,,Medication,2,No,2,No,8,2,No
105-180,6005,5,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,16MAR2015,16MAR2015,1,Mild,2,Not Related,1,No change,2,Resolved,18MAR2015,18MAR2015,None,2,No,2,No,8,2,No
105-180,6007,7,allergic rhinitis,"Respiratory, thoracic and mediastinal disorders",Rhinitis allergic,Allergic rhinitis,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),28MAR2015,28MAR2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,9,2,No
105-180,6008,8,neck pain,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,30MAY2015,30MAY2015,1,Mild,2,Not Related,4,N/A,4,Severity/frequency increased,JUL2015,15JUL2015,Medication,2,No,2,No,10,2,No
105-180,6009,9,allergic reaction to fluticasone,Immune system disorders,Drug hypersensitivity,Drug allergy,"Allergies to foods, food additives, drugs and other chemicals",Allergic conditions,30APR2015,30APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,30APR2015,30APR2015,None,2,No,2,No,10,2,No
105-180,6010,10,neck pain,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,JUL2015,15JUL2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-180,6011,11,back pain - left lower-low back strain,"Injury, poisoning and procedural complications",Muscle strain,Low back strain,"Muscle, tendon and ligament injuries",Injuries NEC,26AUG2015,26AUG2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-224,6001,1,decreased hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),07JUL2015,07JUL2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,10,2,No
105-101,6001,1,lower lip lesion,Gastrointestinal disorders,Oral disorder,Oral lesion,Oral soft tissue disorders NEC,Oral soft tissue conditions,17NOV2014,17NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,20NOV2014,20NOV2014,None,2,No,2,No,2,2,No
105-101,6002,2,viral upper respiratory tract infection,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,19NOV2014,19NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,28NOV2014,28NOV2014,None,2,No,2,No,2,2,No
105-101,6003,3,syncope,Nervous system disorders,Syncope,Syncope,Disturbances in consciousness NEC,Neurological disorders NEC,02DEC2014,02DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,02DEC2014,02DEC2014,None,2,No,2,No,3,2,No
105-101,6004,4,upper respiratory tract infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,27DEC2014,27DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,05JAN2015,05JAN2015,None,2,No,2,No,4,2,No
105-101,6005,5,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,28FEB2015,28FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,05MAR2015,05MAR2015,None,2,No,2,No,7,2,No
105-101,6006,6,Upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,20APR2015,20APR2015,2,Moderate,2,Not Related,1,No change,2,Resolved,30APR2015,30APR2015,None,2,No,2,No,9,2,No
105-101,6007,7,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,13MAY2015,13MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,MAY2015,15MAY2015,Medication,2,No,2,No,9,2,No
105-101,6008,8,thalassemia,"Congenital, familial and genetic disorders",Thalassaemia,Thalassemia,Haemoglobinopathies congenital,Blood and lymphatic system disorders congenital,28APR2015,28APR2015,1,Mild,2,Not Related,1,No change,5,Continuing at end of study participation,,,None,2,No,2,No,9,2,No
105-274,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,26NOV2014,26NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,05DEC2014,05DEC2014,Medication,2,No,2,No,3,2,No
105-274,6002,2,Upper respiratory tract infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,13DEC2014,13DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,19DEC2014,19DEC2014,Medication,2,No,2,No,4.1,2,No
105-274,6003,3,bilateral bacterial conjunctivitis,Infections and infestations,Conjunctivitis bacterial,Conjunctivitis bacterial,Bacterial infections NEC,Bacterial infectious disorders,08JAN2015,08JAN2015,2,Moderate,2,Not Related,1,No change,2,Resolved,14JAN2015,14JAN2015,Medication,2,No,2,No,5.1,2,No
105-274,6004,4,influenza-like illness,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,08JAN2015,08JAN2015,2,Moderate,2,Not Related,1,No change,2,Resolved,10JAN2015,10JAN2015,Medication,2,No,2,No,5.1,2,No
105-274,6005,5,streptococcal pharyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,10JAN2015,10JAN2015,2,Moderate,2,Not Related,1,No change,2,Resolved,15JAN2015,15JAN2015,None,2,No,2,No,5.1,2,No
105-274,6006,6,Viral upper respiratory infection,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,12FEB2015,12FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,23FEB2015,23FEB2015,Medication,2,No,2,No,6,2,No
105-274,6007,7,"acute otitis media, right ear",Infections and infestations,Otitis media acute,Otitis media acute,Ear infections,Infections - pathogen unspecified,12FEB2015,12FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,28FEB2015,28FEB2015,Medication,2,No,2,No,6,2,No
105-274,6008,8,patellofemoral pain syndrome in left knee,Musculoskeletal and connective tissue disorders,Patellofemoral pain syndrome,Patellofemoral pain syndrome,Joint related disorders NEC,Joint disorders,23FEB2015,23FEB2015,2,Moderate,2,Not Related,1,No change,5,Continuing at end of study participation,,,Medication,2,No,2,No,6.1,2,No
105-274,6009,9,dry cough,"Respiratory, thoracic and mediastinal disorders",Cough,Dry cough,Coughing and associated symptoms,Respiratory disorders NEC,20APR2015,20APR2015,1,Mild,2,Not Related,1,No change,2,Resolved,08MAY2015,08MAY2015,None,2,No,2,No,8,2,No
105-274,6010,10,acute otitis media,Infections and infestations,Otitis media acute,Otitis media acute,Ear infections,Infections - pathogen unspecified,30APR2015,30APR2015,1,Mild,2,Not Related,1,No change,2,Resolved,05MAY2015,05MAY2015,Medication,2,No,2,No,8,2,No
105-274,6011,11,Right ear pain,Ear and labyrinth disorders,Ear pain,Ear pain,Ear disorders NEC,Aural disorders NEC,08MAY2015,08MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,17MAY2015,17MAY2015,None,2,No,2,No,9,2,No
105-050,6001,1,pruritic rash on neck + right forearm,Skin and subcutaneous tissue disorders,Rash pruritic,Pruritic rash,Pruritus NEC,Epidermal and dermal conditions,NOV2014,15NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,19NOV2014,19NOV2014,None,2,No,2,No,3,2,No
105-050,6002,2,nasal congestion,"Respiratory, thoracic and mediastinal disorders",Nasal congestion,Nasal congestion,Nasal congestion and inflammations,Upper respiratory tract disorders (excl infections),04DEC2014,04DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,04DEC2014,04DEC2014,None,2,No,2,No,4,2,No
105-050,6003,3,left ankle sprain,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,AUG2015,15AUG2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-233,6001,1,influenza-like illness,General disorders and administration site conditions,Influenza like illness,Influenza like illness,General signs and symptoms NEC,General system disorders NEC,26NOV2014,26NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,08DEC2014,08DEC2014,None,2,No,2,No,3,2,No
105-233,6002,2,UPPER RESPIRATORY TRACT INFECTION,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,22DEC2014,22DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,26JAN2015,26JAN2015,None,2,No,2,No,5.1,2,No
105-233,6003,3,"penile lesion, traumatic",Reproductive system and breast disorders,Genital lesion,Genital lesion,Reproductive tract disorders NEC (excl neoplasms),Reproductive tract disorders NEC,09FEB2015,09FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,02MAR2015,02MAR2015,None,2,No,2,No,6,2,No
105-233,6004,4,"intermittent rash, left upper arm",Skin and subcutaneous tissue disorders,Rash,Rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,DEC2014,15DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,16MAR2015,16MAR2015,None,2,No,2,No,7,2,No
105-233,6005,5,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15OCT2015,15OCT2015,1,Mild,2,Not Related,4,N/A,2,Resolved,22OCT2015,22OCT2015,None,2,No,2,No,11,2,No
105-233,6006,6,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,14NOV2015,14NOV2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-233,6007,7,right foot pain,Musculoskeletal and connective tissue disorders,Pain in extremity,Foot pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,NOV2015,15NOV2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-054,6001,1,right shoulder pain,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,20JUL2015,20JUL2015,1,Mild,2,Not Related,4,N/A,2,Resolved,SEP2015,15SEP2015,Medication,2,No,2,No,10,2,No
105-247,6001,1,Diarrhea,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,04SEP2014,04SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,05SEP2014,05SEP2014,Medication,2,No,2,No,2,2,No
105-247,6002,2,Cat allergy,Immune system disorders,Allergy to animal,Allergy to animal,Allergic conditions NEC,Allergic conditions,13SEP2014,13SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,13SEP2014,13SEP2014,Medication,2,No,2,No,3,2,No
105-247,6003,3,Upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,13SEP2014,13SEP2014,2,Moderate,2,Not Related,1,No change,2,Resolved,28SEP2014,28SEP2014,None,2,No,2,No,3,2,No
105-247,6004,4,fever,General disorders and administration site conditions,Pyrexia,Fever,Febrile disorders,Body temperature conditions,16NOV2014,16NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,16NOV2014,16NOV2014,Medication,2,No,2,No,6,2,No
105-247,6005,5,Acid Reflux,Gastrointestinal disorders,Gastrooesophageal reflux disease,Acid reflux (esophageal),Gastrointestinal atonic and hypomotility disorders NEC,Gastrointestinal motility and defaecation conditions,16NOV2014,16NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,16NOV2014,16NOV2014,Medication,2,No,2,No,6,2,No
105-247,6006,6,diarrhea,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,07NOV2014,07NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,07NOV2014,07NOV2014,Medication,2,No,2,No,6,2,No
105-247,6007,7,seasonal allergies,Immune system disorders,Seasonal allergy,Seasonal allergy,Atopic disorders,Allergic conditions,07NOV2014,07NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,08NOV2014,08NOV2014,Medication,2,No,2,No,6,2,No
105-247,6008,8,anxiety,Psychiatric disorders,Anxiety,Anxiety,Anxiety symptoms,Anxiety disorders and symptoms,10MAR2015,10MAR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,01APR2015,01APR2015,Medication,2,No,2,No,9.1,2,No
105-247,6009,9,sinus infection,Infections and infestations,Sinusitis,Sinus infection,Upper respiratory tract infections,Infections - pathogen unspecified,15APR2015,15APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,23APR2015,23APR2015,Medication,2,No,2,No,9.2,2,No
105-162,6001,1,musculoskeletal back pain,Musculoskeletal and connective tissue disorders,Back pain,Back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,13MAR2015,13MAR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,21MAR2015,21MAR2015,Medication,2,No,2,No,9,2,No
105-162,6002,2,Fracture 4th digit R hand,"Injury, poisoning and procedural complications",Hand fracture,Fractured finger,Limb fractures and dislocations,Bone and joint injuries,09SEP2015,09SEP2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Procedure/Surgery,2,No,2,No,11,2,No
105-119,6001,1,rash - R upper arm,Skin and subcutaneous tissue disorders,Rash,Rash over arms,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,04NOV2014,04NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,14NOV2014,14NOV2014,None,2,No,2,No,5,2,No
105-119,6002,2,URI,Infections and infestations,Upper respiratory tract infection,URTI,Upper respiratory tract infections,Infections - pathogen unspecified,24SEP2015,24SEP2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-214,6001,1,Decreased neutrophil count,Investigations,Neutrophil count decreased,Neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),10NOV2014,10NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,30DEC2014,30DEC2014,None,2,No,2,No,5,2,No
105-149,6001,1,increased ALT,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,11NOV2014,11NOV2014,1,Mild,1,Related,1,No change,2,Resolved,29DEC2014,29DEC2014,None,2,No,2,No,5,2,No
105-149,6002,2,Lymphadenopathy - bilateral axillary lymph nodes 0.5 x 0.5 cm,Blood and lymphatic system disorders,Lymphadenopathy,Lymphadenopathy axillary,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",12MAR2015,12MAR2015,1,Mild,2,Not Related,1,No change,5,Continuing at end of study participation,,,None,2,No,2,No,8,2,No
105-154,6001,1,dizziness,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,21OCT2014,21OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,21OCT2014,21OCT2014,None,2,No,2,No,2,2,No
105-110,6001,1,Decreased Hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),27APR2015,27APR2015,3,Severe,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,9,2,No
105-110,6002,2,Decreased Platelets,Investigations,Platelet count decreased,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),27APR2015,27APR2015,1,Mild,2,Not Related,4,N/A,2,Resolved,18MAY2015,18MAY2015,None,2,No,2,No,9,2,No
105-135,6001,1,retro orbital pain bilaterally,Eye disorders,Eye pain,Retro-orbital pain,Ocular disorders NEC,Eye disorders NEC,28NOV2014,28NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,05DEC2014,05DEC2014,Medication,2,No,2,No,3,2,No
105-135,6002,2,Psoriasis,Skin and subcutaneous tissue disorders,Psoriasis,Psoriasis,Psoriatic conditions,Epidermal and dermal conditions,28DEC2014,28DEC2014,2,Moderate,2,Not Related,1,No change,2,Resolved,12JAN2015,12JAN2015,Medication,2,No,2,No,5.1,2,No
105-135,6003,3,hematuria,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,28MAY2015,28MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,04JUN2015,04JUN2015,Procedure/Surgery,2,No,2,No,9,2,No
105-098,6001,1,vertigo - benign positional,Ear and labyrinth disorders,Vertigo positional,Benign positional vertigo,Inner ear signs and symptoms,Inner ear and VIIIth cranial nerve disorders,24FEB2015,24FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,24FEB2015,24FEB2015,None,2,No,2,No,6,2,No
105-098,6002,2,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06MAR2015,06MAR2015,1,Mild,2,Not Related,1,No change,2,Resolved,09MAR2015,09MAR2015,Medication,2,No,2,No,7,2,No
105-175,6001,1,scraped Left ankle,"Injury, poisoning and procedural complications",Scratch,Scratch,Skin injuries NEC,Injuries NEC,27DEC2014,27DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,05JAN2015,05JAN2015,Medication,2,No,2,No,4,2,No
105-175,6002,2,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,08JAN2015,08JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,10JAN2015,10JAN2015,Medication,2,No,2,No,4,2,No
105-175,6003,3,Intermitent nausea,*** Not in MedDRA version 19.0 ***,*** Not in MedDRA version 19.0 ***,,,,22FEB2015,22FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,24FEB2015,24FEB2015,Medication,2,No,2,No,6,2,No
105-175,6004,4,Diarrhea,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,08JUN2015,08JUN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,08JUN2015,08JUN2015,Medication,2,No,2,No,8,2,No
105-014,6001,1,Anemia,Blood and lymphatic system disorders,Anaemia,Anemia,Anaemias NEC,Anaemias nonhaemolytic and marrow depression,03MAR2015,03MAR2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,9,2,No
105-006,6001,1,Allergic reaction to hair dye,Immune system disorders,Hypersensitivity,Allergic reaction,Allergic conditions NEC,Allergic conditions,30SEP2014,30SEP2014,2,Moderate,2,Not Related,1,No change,2,Resolved,11OCT2014,11OCT2014,Medication,2,No,2,No,3,2,No
105-006,6002,2,Decreased neutrophil count,Investigations,Neutrophil count decreased,Neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),11NOV2014,11NOV2014,1,Mild,1,Related,1,No change,2,Resolved,17DEC2014,17DEC2014,None,2,No,2,No,5,2,No
105-055,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,19OCT2014,19OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,24OCT2014,24OCT2014,None,2,No,2,No,4,2,No
105-055,6002,2,Sprained R Ankle,"Injury, poisoning and procedural complications",Ligament sprain,Ankle sprain,"Muscle, tendon and ligament injuries",Injuries NEC,18JUL2015,18JUL2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Medication,2,No,2,No,11,2,No
105-193,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,30OCT2014,30OCT2014,2,Moderate,2,Not Related,1,No change,2,Resolved,10NOV2014,10NOV2014,None,2,No,2,No,4,2,No
105-193,6002,2,Urinary Tract infection,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,15APR2015,15APR2015,2,Moderate,2,Not Related,4,N/A,2,Resolved,22APR2015,22APR2015,Medication,2,No,2,No,10,2,No
105-193,6003,3,Allergy to Minocycline,Immune system disorders,Drug hypersensitivity,Drug allergy,"Allergies to foods, food additives, drugs and other chemicals",Allergic conditions,03APR2015,03APR2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,10,2,No
105-116,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,06JAN2015,06JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,15JAN2015,15JAN2015,None,2,No,2,No,6,2,No
105-008,6001,1,Tooth Abscess,Infections and infestations,Tooth abscess,Tooth abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,10JAN2015,10JAN2015,1,Mild,2,Not Related,1,No change,2,Resolved,24JAN2015,24JAN2015,Medication,2,No,2,No,6,2,No
105-295,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,15NOV2014,15NOV2014,2,Moderate,2,Not Related,1,No change,2,Resolved,21NOV2014,21NOV2014,Medication,2,No,2,No,4,2,No
105-295,6002,2,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,01DEC2014,01DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,12DEC2014,12DEC2014,Medication,2,No,2,No,5,2,No
105-112,6001,1,Nodule at apex of L deltoid below injection site.,General disorders and administration site conditions,Nodule,Nodule,Mass conditions NEC,Tissue disorders NEC,25NOV2014,25NOV2014,1,Mild,1,Related,1,No change,2,Resolved,09FEB2015,09FEB2015,None,2,No,2,No,3,2,No
105-112,6002,2,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,05DEC2014,05DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,03JAN2015,03JAN2015,Medication,2,No,2,No,4,2,No
105-112,6003,3,Viral Syndrome,Infections and infestations,Viral infection,Viral syndrome,Viral infections NEC,Viral infectious disorders,23DEC2014,23DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,24DEC2014,24DEC2014,Medication,2,No,2,No,4,2,No
105-112,6004,4,Mildly tender 3mm X 3mm nodule @ apex of left deltoid. Approx 8.5cm from injection site. (post injec,General disorders and administration site conditions,Nodule,Nodule,Mass conditions NEC,Tissue disorders NEC,11FEB2015,11FEB2015,1,Mild,1,Related,1,No change,5,Continuing at end of study participation,,,None,2,No,2,No,6,2,No
105-048,6001,1,Vasovagal Episode related to injection,Nervous system disorders,Presyncope,Vasovagal reaction,Neurological signs and symptoms NEC,Neurological disorders NEC,06OCT2014,06OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,06OCT2014,06OCT2014,None,2,No,2,No,4,2,No
105-048,6002,2,flu-like symptoms,General disorders and administration site conditions,Influenza like illness,Flu-like symptoms,General signs and symptoms NEC,General system disorders NEC,12FEB2015,12FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,17FEB2015,17FEB2015,Medication,2,No,2,No,8,2,No
105-123,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,27SEP2014,27SEP2014,1,Mild,2,Not Related,1,No change,2,Resolved,08OCT2014,08OCT2014,Medication,2,No,2,No,3,2,No
105-290,6001,1,decreased absolute neutrophil count,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),23DEC2014,23DEC2014,1,Mild,1,Related,1,No change,2,Resolved,07JAN2015,07JAN2015,None,2,No,2,No,3,2,No
105-290,6002,2,decreased absolute neutrophil count,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),22JUN2015,22JUN2015,1,Mild,1,Related,4,N/A,2,Resolved,06JUL2015,06JUL2015,None,2,No,2,No,9,2,No
105-261,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10MAR2015,10MAR2015,1,Mild,2,Not Related,1,No change,2,Resolved,14MAR2015,14MAR2015,Medication,2,No,2,No,6,2,No
105-261,6002,2,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,17JUN2015,17JUN2015,1,Mild,2,Not Related,4,N/A,2,Resolved,24JUN2015,24JUN2015,Medication,2,No,2,No,9,2,No
105-059,6001,1,Injured left shoulder,"Injury, poisoning and procedural complications",Joint injury,Injury to shoulder NOS,Bone and joint injuries NEC,Bone and joint injuries,08NOV2014,08NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,22NOV2014,22NOV2014,Medication,2,No,2,No,6,2,No
105-059,6003,3,Viral influenza,Infections and infestations,Influenza,Influenza,Influenza viral infections,Viral infectious disorders,03FEB2015,03FEB2015,2,Moderate,2,Not Related,1,No change,2,Resolved,14FEB2015,14FEB2015,Medication,2,No,2,No,8,2,No
105-273,6001,1,bacterial upper respiratory infection,Infections and infestations,Upper respiratory tract infection bacterial,Upper respiratory tract infection bacterial,Bacterial infections NEC,Bacterial infectious disorders,18OCT2014,18OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,27OCT2014,27OCT2014,Medication,2,No,2,No,5,2,No
105-273,6002,2,urinary tract infection,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,04FEB2015,04FEB2015,2,Moderate,2,Not Related,1,No change,2,Resolved,11FEB2015,11FEB2015,Medication,2,No,2,No,8,2,No
105-114,6001,1,decreased hemoglobin related to menorrhagia,Reproductive system and breast disorders,Menorrhagia,Menorrhagia,Menstruation with increased bleeding,Menstrual cycle and uterine bleeding disorders,26MAY2015,26MAY2015,1,Mild,2,Not Related,4,N/A,4,Severity/frequency increased,26JUN2015,26JUN2015,None,2,No,2,No,10,2,No
105-114,6002,2,decreased hemoglobin related to menorrhagia,Reproductive system and breast disorders,Menorrhagia,Menorrhagia,Menstruation with increased bleeding,Menstrual cycle and uterine bleeding disorders,26JUN2015,26JUN2015,2,Moderate,2,Not Related,4,N/A,5,Continuing at end of study participation,,,Other,2,No,2,No,10.1,2,No
105-114,6003,3,neutropenia,Blood and lymphatic system disorders,Neutropenia,Neutropenia,Neutropenias,White blood cell disorders,26AUG2015,26AUG2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-286,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18FEB2015,18FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,24FEB2015,24FEB2015,Medication,2,No,2,No,8,2,No
105-286,6002,2,"abrasion secondary trauma, lower leg","Injury, poisoning and procedural complications",Skin abrasion,Abrasions,Skin injuries NEC,Injuries NEC,15AUG2015,15AUG2015,1,Mild,2,Not Related,4,N/A,5,Continuing at end of study participation,,,None,2,No,2,No,11,2,No
105-024,6001,1,dental abscess,Infections and infestations,Tooth abscess,Dental abscess,Dental and oral soft tissue infections,Infections - pathogen unspecified,07NOV2014,07NOV2014,1,Mild,2,Not Related,1,No change,2,Resolved,08NOV2014,08NOV2014,Medication,2,No,2,No,6,2,No
105-024,6002,2,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,10FEB2015,10FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,17FEB2015,17FEB2015,Medication,2,No,2,No,8,2,No
105-084,6001,1,pain in left elbow; secondary fall in shower,Musculoskeletal and connective tissue disorders,Arthralgia,Pain in elbow,Joint related signs and symptoms,Joint disorders,02OCT2014,02OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,15OCT2014,15OCT2014,Medication,2,No,2,No,4,2,No
105-084,6002,2,pain in buttocks; secondary fall in shower,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Buttock pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,02OCT2014,02OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,15OCT2014,15OCT2014,Medication,2,No,2,No,4,2,No
105-206,6001,1,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,19OCT2014,19OCT2014,1,Mild,2,Not Related,1,No change,2,Resolved,25OCT2014,25OCT2014,None,2,No,2,No,5,2,No
105-206,6002,2,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,04MAR2015,04MAR2015,2,Moderate,2,Not Related,1,No change,2,Resolved,09MAR2015,09MAR2015,Medication,2,No,2,No,8,2,No
105-158,6001,1,decreased hemoglobin,Investigations,Haemoglobin decreased,Decreased hemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),19DEC2014,19DEC2014,1,Mild,1,Related,1,No change,2,Resolved,15JAN2015,15JAN2015,None,2,No,2,No,7,2,No
105-158,6002,2,streptococcal pharyngitis,Infections and infestations,Pharyngitis streptococcal,Streptococcal pharyngitis,Streptococcal infections,Bacterial infectious disorders,09FEB2015,09FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,21FEB2015,21FEB2015,Medication,2,No,2,No,8,2,No
105-158,6003,3,contact dermatitis right and left upper arm,Skin and subcutaneous tissue disorders,Dermatitis contact,Contact dermatitis,Dermatitis and eczema,Epidermal and dermal conditions,19FEB2015,19FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,21FEB2015,21FEB2015,None,2,No,2,No,8,2,No
105-130,6001,1,Upper Respiratory Infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,18DEC2014,18DEC2014,1,Mild,2,Not Related,1,No change,2,Resolved,23DEC2014,23DEC2014,Medication,2,No,2,No,7,2,No
105-239,6001,1,left axillary node tenderness,Blood and lymphatic system disorders,Lymph node pain,Lymph node tenderness,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",18OCT2014,18OCT2014,1,Mild,1,Related,1,No change,2,Resolved,20OCT2014,20OCT2014,None,2,No,2,No,4,2,No
105-239,6002,2,left axillary node enlargement,Blood and lymphatic system disorders,Lymphadenopathy,Axillary lymph nodes enlarged,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",18OCT2014,18OCT2014,1,Mild,1,Related,1,No change,2,Resolved,20OCT2014,20OCT2014,None,2,No,2,No,4,2,No
105-239,6003,3,upper respiratory infection,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,24FEB2015,24FEB2015,1,Mild,2,Not Related,1,No change,2,Resolved,02MAR2015,02MAR2015,Medication,2,No,2,No,8,2,No
105-239,6004,4,increased ALT,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,21MAY2015,21MAY2015,1,Mild,2,Not Related,4,N/A,2,Resolved,18SEP2015,18SEP2015,None,2,No,2,No,10,2,No