PUB_ID,VISIT,AEPAGENUM,AEDIAG,AEMDVER,AESOC,AEMDRA,LL_NAME,HL_NAME,HLG_NAME,AESEVE,AESEVE_TXT,AEREL,AEREL_TXT,AEDRAD,AEDRADC,AEOUTC,AEOUTCC,AETREATMENT,AEICH,AEICHC,AEDAIDS,AEDAIDSC,AEVISIT,AESAERCT,AESAERCTC
120-128,6001,1,Increased ALT,22.1,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-107,6001,1,Injection site pruritis,22.1,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-131,6001,1,Left shoulder muscle strain,22.1,"Injury, poisoning and procedural complications",Muscle strain,Muscle strain,"Muscle, tendon and ligament injuries",Injuries NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,"Medication, Other",No,No,No,No,4,No,No
120-131,6002,2,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-131,6003,3,Vertigo,22.1,Ear and labyrinth disorders,Vertigo,Vertigo,Inner ear signs and symptoms,Inner ear and VIIIth cranial nerve disorders,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-035,6001,1,Left shoulder dislocation,22.1,"Injury, poisoning and procedural complications",Joint dislocation,Dislocation of shoulder,Fractures and dislocations NEC,Bone and joint injuries,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,"Medication, Other",No,No,No,No,6,No,No
120-035,6002,2,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,7.1,No,No
120-002,6001,1,Presyncopal episode,22.1,Nervous system disorders,Presyncope,Presyncope,Neurological signs and symptoms NEC,Neurological disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-002,6002,2,Vaginal yeast infection,22.1,Infections and infestations,Vulvovaginal mycotic infection,Vaginal yeast infection,Fungal infections NEC,Fungal infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-002,6003,3,Increased Creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-008,6001,1,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-159,6001,1,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-077,6001,1,Intermittent Right Shoulder Pain,22.1,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,Shoulder pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-019,6001,1,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-101,6001,1,depression,22.1,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,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,9,No,No
120-031,6001,1,Altitude sickness,22.1,"Injury, poisoning and procedural complications",Hypobarism,Altitude sickness,Atmospheric pressure injuries,Injuries by physical agents,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-031,6002,2,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-043,6001,1,Gastrointestinal illness,22.1,Infections and infestations,Gastrointestinal infection,Gastrointestinal infection,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-043,6002,2,Musculoskeletal pain (left arm),22.1,Musculoskeletal and connective tissue disorders,Pain in extremity,Painful L arm,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-059,6001,1,decreased appetite,22.1,Metabolism and nutrition disorders,Decreased appetite,Decreased appetite,Appetite disorders,Appetite and general nutritional disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-059,6002,2,Flu like symptoms,22.1,General disorders and administration site conditions,Influenza like illness,Flu like symptoms,General signs and symptoms NEC,General system disorders NEC,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-114,6001,1,Diarrhea,22.1,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-114,6002,2,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-114,6003,3,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-114,6004,4,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,9,No,No
120-114,6005,5,Attention deficit hyperactivity disorder,22.1,Psychiatric disorders,Attention deficit/hyperactivity disorder,Attention deficit/hyperactivity disorder,Attention deficit and disruptive behaviour disorders,Cognitive and attention disorders and disturbances,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,10,No,No
120-102,6001,1,insomnia,22.1,Psychiatric disorders,Insomnia,Insomnia,Disturbances in initiating and maintaining sleep,Sleep disorders and disturbances,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,9,No,No
120-102,6002,2,night sweats,22.1,Skin and subcutaneous tissue disorders,Night sweats,Night sweats,Apocrine and eccrine gland disorders,Skin appendage conditions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-014,6001,1,diarrhea,22.1,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-014,6002,2,Pruritic skin on outer left thigh,22.1,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-014,6003,3,pruritic area - outer anterior surface of right thigh - midway between inguinal fold and knee.,22.1,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-014,6004,4,bacterial vaginosis,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-158,6001,1,gastrointestinal upset,22.1,Gastrointestinal disorders,Abdominal discomfort,Gastrointestinal upset,Gastrointestinal signs and symptoms NEC,Gastrointestinal signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-158,6002,2,viral upper respiratory infection,22.1,Infections and infestations,Viral upper respiratory tract infection,Viral upper respiratory tract infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-158,6003,3,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,7,No,No
120-158,6004,4,rhinorrhea,22.1,"Respiratory, thoracic and mediastinal disorders",Rhinorrhoea,Rhinorrhea,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-027,6001,1,Upset stomach,22.1,Gastrointestinal disorders,Abdominal discomfort,Upset stomach,Gastrointestinal signs and symptoms NEC,Gastrointestinal signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-027,6002,2,Gastrointestinal upset,22.1,Gastrointestinal disorders,Abdominal discomfort,Gastrointestinal upset,Gastrointestinal signs and symptoms NEC,Gastrointestinal signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-027,6003,3,Viral respiratory illness,22.1,Infections and infestations,Respiratory tract infection viral,Respiratory tract infection viral,Viral infections NEC,Viral infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-027,6004,4,dyshidrotic eczema,22.1,Skin and subcutaneous tissue disorders,Dyshidrotic eczema,Dyshidrotic eczema,Dermatitis and eczema,Epidermal and dermal conditions,Moderate,Moderate,Not Related,Not Related,No change,No change,Continuing at End of Study,Continuing at End of Study,Medication,No,No,No,No,8,No,No
120-104,6001,1,Viral Illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-104,6002,2,Elevated Blood Pressure,22.1,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Severity/Frequency,Severity/Frequency,None,No,No,No,No,7,No,No
120-104,6003,3,Elevated Blood Pressure,22.1,Investigations,Blood pressure increased,Increased blood pressure,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-104,6004,4,Elevated Blood Pressure,22.1,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,None,No,No,No,No,10,No,No
120-126,6001,1,bilateral knee pain due to trauma from fall,22.1,Musculoskeletal and connective tissue disorders,Arthralgia,Knee pain,Joint related signs and symptoms,Joint disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-126,6002,2,left calf pain,22.1,Musculoskeletal and connective tissue disorders,Pain in extremity,Calf pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-126,6003,3,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-145,6001,1,dorsum of right hand with maculopapular rash over MCP joints,22.1,Skin and subcutaneous tissue disorders,Rash maculo-papular,Maculopapular rash,"Rashes, eruptions and exanthems NEC",Epidermal and dermal conditions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-160,6001,1,right deltoid injection site itching,22.1,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-160,6002,2,Asymptomatic genitourinary chlamydia,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-009,6001,1,L Chest wall discomfort,22.1,General disorders and administration site conditions,Chest discomfort,Chest discomfort,Pain and discomfort NEC,General system disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4.1,No,No
120-009,6002,2,Gastritis,22.1,Gastrointestinal disorders,Gastritis,Gastritis,Gastritis (excl infective),Gastrointestinal inflammatory conditions,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,11,No,No
120-146,6001,1,viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4.1,No,No
120-146,6002,2,viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-146,6003,3,mild upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,8,No,No
120-082,6002,2,gastroenteritis,22.1,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-023,6001,1,Upper respiratory illness,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-023,6002,2,elevated blood pressure,22.1,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-023,6003,3,Paresthesia-- right hand and fingers,22.1,Nervous system disorders,Paraesthesia,Paresthesia,Paraesthesias and dysaesthesias,Neurological disorders NEC,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,8.1,No,No
120-023,6005,5,Elevated blood pressure,22.1,Investigations,Blood pressure increased,Blood pressure increased,Vascular tests NEC (incl blood pressure),Cardiac and vascular investigations (excl enzyme tests),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,"Medication, Other",No,No,No,No,10,No,No
120-056,6002,2,1cm tender lymph node right axillae,22.1,Blood and lymphatic system disorders,Lymph node pain,Lymph node tenderness,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,8.1,No,No
120-056,6003,3,Pruritus right deltoid injection site,22.1,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-056,6004,4,Neck pain,22.1,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-121,6002,2,viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4.1,No,No
120-121,6003,3,pruritus at injection site R,22.1,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-121,6004,4,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-111,6001,1,Pruritus L deltoid injection site,22.1,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2,No,No
120-111,6002,2,increased creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-111,6003,3,migraine headache,22.1,Nervous system disorders,Migraine,Migraine headache,Migraine headaches,Headaches,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-111,6004,4,sinus congestion,22.1,"Respiratory, thoracic and mediastinal disorders",Sinus congestion,Sinus congestion,Paranasal sinus disorders (excl infections and neoplasms),Upper respiratory tract disorders (excl infections),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-111,6005,5,back pain,22.1,Musculoskeletal and connective tissue disorders,Back pain,Back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4.1,No,No
120-111,6006,6,concussion with post-concussive syndrome,22.1,"Injury, poisoning and procedural complications",Post concussion syndrome,Post concussion syndrome,Non-site specific injuries NEC,Injuries NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-111,6008,8,pneumonia,22.1,Infections and infestations,Pneumonia,Pneumonia,Lower respiratory tract and lung infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-049,6001,1,pleuritic chest pain,22.1,"Respiratory, thoracic and mediastinal disorders",Pleuritic pain,Pleuritic pain,Lower respiratory tract signs and symptoms,Respiratory tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2.1,No,No
120-049,6002,2,Viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3.1,No,No
120-049,6003,3,Viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-122,6001,1,proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3.1,No,No
120-122,6003,3,headaches,22.1,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-124,6001,1,pain:right should injury,22.1,"Injury, poisoning and procedural complications",Limb injury,Shoulder injury,Site specific injuries NEC,Injuries NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-124,6002,2,Upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6.3,No,No
120-124,6003,3,Viral illness,22.1,Infections and infestations,Viral infection,Viral infection,Viral infections NEC,Viral infectious disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-124,6005,5,Torn right anterior cruciate ligament,22.1,"Injury, poisoning and procedural complications",Ligament rupture,Anterior cruciate ligament tear,"Muscle, tendon and ligament injuries",Injuries NEC,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,Other,No,No,No,No,11,No,No
120-070,6002,2,folliculitis on neck,22.1,Infections and infestations,Folliculitis,Folliculitis,Skin structures and soft tissue infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4.1,No,No
120-001,6001,1,Mild pain in bicep tendon of left arm,22.1,Musculoskeletal and connective tissue disorders,Tendon pain,Tendon pain,Tendon disorders,"Tendon, ligament and cartilage disorders",Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-001,6002,2,Elevated ALT,22.1,Investigations,Alanine aminotransferase increased,ALT increased,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-138,6001,1,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-038,6001,1,Swollen lymph node,22.1,Blood and lymphatic system disorders,Lymphadenopathy,Swollen lymph nodes,Lymphatic system disorders NEC,"Spleen, lymphatic and reticuloendothelial system disorders",Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-038,6002,2,Gastroenteritis,22.1,Infections and infestations,Gastroenteritis,Gastroenteritis,Abdominal and gastrointestinal infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-038,6003,3,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-150,6001,1,Pain secondary to chest masculinization surgery,22.1,"Injury, poisoning and procedural complications",Procedural pain,Post procedural pain,Non-site specific procedural complications,Procedural related injuries and complications NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-150,6002,2,swelling 2 degree to chest masculization surgery,22.1,"Injury, poisoning and procedural complications",Post procedural swelling,Post procedural swelling,Non-site specific procedural complications,Procedural related injuries and complications NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-150,6003,3,upper respiratory infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-112,6001,1,decreased creatinine clearance,22.1,Investigations,Creatinine renal clearance decreased,Creatinine clearance decreased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-086,6001,1,Pain related to meniscus repair (surgical procedure),22.1,"Injury, poisoning and procedural complications",Procedural pain,Post procedural pain,Non-site specific procedural complications,Procedural related injuries and complications NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-129,6001,1,injection site itching (left deltoid),22.1,General disorders and administration site conditions,Injection site pruritus,Injection site itching,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4.1,No,No
120-129,6002,2,Depression,22.1,Psychiatric disorders,Depression,Depression,Depressive disorders,Depressed mood disorders and disturbances,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Other,No,No,No,No,8,No,No
120-016,6002,2,Upper Respiratory Illness,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,9,No,No
120-052,6001,1,"sunburn with peeling on neck, forearm and both elbows",22.1,"Injury, poisoning and procedural complications",Sunburn,Sunburn,Radiation injuries,Injuries by physical agents,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-052,6002,2,Grade 1 Protein-Urinalysis,22.1,Investigations,Protein urine present,Protein urine present,Urinalysis NEC,Renal and urinary tract investigations and urinalyses,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-052,6003,3,elevated creatinine level,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-052,6007,7,elevated creatinine level,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-012,6001,1,Left ear cerumen impaction,22.1,Ear and labyrinth disorders,Cerumen impaction,Cerumen impaction,External ear disorders NEC,External ear disorders (excl congenital),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Procedure/Surgery,No,No,No,No,7,No,No
120-012,6003,3,Grade 1 Proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-157,6001,1,"sunburn on back, breasts and arms, bilaterally",22.1,"Injury, poisoning and procedural complications",Sunburn,Sunburn,Radiation injuries,Injuries by physical agents,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-157,6002,2,viral pharyngitis,22.1,Infections and infestations,Viral pharyngitis,Viral pharyngitis,Viral infections NEC,Viral infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6.2,No,No
120-157,6003,3,Elevated Alanine Aminotransferase,22.1,Investigations,Alanine aminotransferase increased,Alanine aminotransferase increased,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-157,6004,4,Upper Respiratory Illness,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-157,6005,5,nosebleed,22.1,"Respiratory, thoracic and mediastinal disorders",Epistaxis,Nosebleed,Nasal disorders NEC,Upper respiratory tract disorders (excl infections),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,8.1,No,No
120-157,6006,6,"Pruritis, right elbow",22.1,Skin and subcutaneous tissue disorders,Pruritus,Pruritus,Pruritus NEC,Epidermal and dermal conditions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,9,No,No
120-096,6001,1,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-096,6002,2,Proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-096,6003,3,Upper Respiratory Infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-096,6004,4,Proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-089,6001,1,diarrhea,22.1,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-089,6002,2,diarrhea,22.1,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-089,6003,3,pruritis (itching at injection site right arm),22.1,General disorders and administration site conditions,Injection site pruritus,Injection site pruritus,Injection site reactions,Administration site reactions,Mild,Mild,Related,Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-032,6001,1,Upper Respiratory Illness,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3.1,No,No
120-140,6001,1,"diarrhea, bloating pain",22.1,Gastrointestinal disorders,Diarrhoea,Diarrhea,Diarrhoea (excl infective),Gastrointestinal motility and defaecation conditions,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5,No,No
120-140,6002,2,upper respiratory illness,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6,No,No
120-140,6003,3,sore throat,22.1,"Respiratory, thoracic and mediastinal disorders",Oropharyngeal pain,Sore throat,Upper respiratory tract signs and symptoms,Respiratory tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-140,6004,4,"laceration on index finger of left hand, ~1.5 inches in length (2 cm)",22.1,"Injury, poisoning and procedural complications",Skin laceration,Laceration of finger,Skin injuries NEC,Injuries NEC,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-047,6001,1,ASYMPTOMATIC GENITOURINARY CHLAMYDIA,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-081,6001,1,HEMOGLOBIN LOW,22.1,Investigations,Haemoglobin decreased,Hemoglobin low,Red blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-055,6001,1,CREATINING HIGH,22.1,Investigations,Blood creatinine increased,Creatinine high,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-055,6002,2,URINARY TRACT INFECTION,22.1,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-055,6003,3,ASYMPTOMATIC GENITOURINARY CHLAMYDIA,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10.2,No,No
120-003,6001,1,NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Neutrophil count low,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-003,6002,2,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-003,6003,3,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-154,6001,1,INCREASE ASPARTATE TRANSAMINASE,22.1,Investigations,Aspartate aminotransferase increased,Aspartate aminotransferase increase,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-154,6002,2,PROTEINURIA,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-154,6003,3,GREATININE HIGH,22.1,Investigations,Blood creatinine increased,Creatinine high,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-154,6005,5,GLYCOSURIA,22.1,Renal and urinary disorders,Glycosuria,Glycosuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-154,6007,7,INCREASED CREATININE,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-154,6008,8,INCREASED AST,22.1,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-054,6001,1,MALARIA,22.1,Infections and infestations,Malaria,Malaria,Plasmodia infections,Protozoal infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6.1,No,No
120-054,6003,3,PROTEINURIA,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6.1,No,No
120-054,6004,4,PLATELETS DECREASED,22.1,Investigations,Platelet count decreased,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6.1,No,No
120-054,6005,5,CREATININE HIGH,22.1,Investigations,Blood creatinine increased,Creatinine high,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6.1,No,No
120-054,6006,6,ASYMPTOMATIC GENITOURINARY CHLAMYDIA,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-075,6001,1,VAGINAL FUNGAL INFECTION,22.1,Infections and infestations,Vulvovaginal mycotic infection,Fungal vulvovaginitis,Fungal infections NEC,Fungal infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-075,6002,2,URINARY TRACT INFECTION,22.1,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-034,6001,1,HEMATURIA,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-133,6001,1,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-133,6002,2,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-133,6003,3,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-133,6004,4,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-133,6005,5,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-116,6001,1,ASYMPTOMATIC GENITOURINARY CHLAMYDIA,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-028,6001,1,HEMATURIA,22.1,Renal and urinary disorders,Haematuria,Hematuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-098,6001,1,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,None,No,No,No,No,5,No,No
120-098,6002,2,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-098,6003,3,PLATELETS DECREASED,22.1,Investigations,Platelet count decreased,Platelets decreased,Platelet analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-098,6004,4,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-098,6005,5,WBC DECREASE,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-098,6006,6,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,None,No,No,No,No,10,No,No
120-024,6001,1,ASYMPTOMATIC VAGINAL TRICHOMONIASIS,22.1,Infections and infestations,Vulvovaginitis trichomonal,Vaginitis trichomonal,Trichomonas infections,Protozoal infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-058,6001,1,NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Neutrophil count low,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Severity/Frequency,Severity/Frequency,Medication,No,No,No,No,3,No,No
120-058,6002,2,NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Neutrophil count low,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-058,6003,3,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,6,No,No
120-058,6004,4,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,None,No,No,No,No,10,No,No
120-058,6005,5,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Severe,Severe,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Continuing at End of Study,Continuing at End of Study,Medication,No,No,No,No,10,No,No
120-080,6001,1,PROTENURIA,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-113,6001,1,CREATININE HIGH,22.1,Investigations,Blood creatinine increased,Creatinine high,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-094,6001,1,NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Neutrophil count low,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-094,6002,2,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-099,6001,1,WBC DECREASE,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-099,6002,2,NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Neutrophil count low,White blood cell analyses,Haematology investigations (incl blood groups),Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-099,6003,3,FLU LIKE ILLNESS,22.1,General disorders and administration site conditions,Influenza like illness,Flu-like illness,General signs and symptoms NEC,General system disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5.1,No,No
120-099,6004,4,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-099,6006,6,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-010,6001,1,AST HIGH,22.1,Investigations,Aspartate aminotransferase increased,AST high,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-010,6002,2,ALT HIGH,22.1,Investigations,Alanine aminotransferase increased,ALT high,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-071,6001,1,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-071,6002,2,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Severe,Severe,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-071,6003,3,WBC DECREASED,22.1,Investigations,White blood cell count decreased,WBC decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-071,6004,4,ABSOLUTE NEUTROPHIL COUNT LOW,22.1,Investigations,Neutrophil count decreased,Absolute neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-100,6001,1,CREATININE HIGH,22.1,Investigations,Blood creatinine increased,Creatinine high,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-100,6002,2,ACUTE BRONCHITIS,22.1,Infections and infestations,Bronchitis,Acute bronchitis,Lower respiratory tract and lung infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,6.1,No,No
120-148,6001,1,ASYMPTOMATIC GENITOURINARY CHLAMYDIA,22.1,Infections and infestations,Genitourinary chlamydia infection,Genitourinary chlamydia infection,Chlamydial infections,Chlamydial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-119,6002,2,gastritis,22.1,Gastrointestinal disorders,Gastritis,Gastritis,Gastritis (excl infective),Gastrointestinal inflammatory conditions,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-119,6003,3,urinary tract infecton,22.1,Infections and infestations,Urinary tract infection,Urinary tract infection,Urinary tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,8.1,No,No
120-120,6001,1,high levels of alanine transferase(alt),22.1,Investigations,Alanine aminotransferase increased,ALT high,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-120,6002,2,BACTERIAL VAGINOSIS(SYMPTOMATIC),22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-013,6001,1,headache,22.1,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-013,6002,2,malaise,22.1,General disorders and administration site conditions,Malaise,Malaise,Asthenic conditions,General system disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-013,6004,4,bilaterla allergic conjunctivitis,22.1,Eye disorders,Conjunctivitis allergic,Allergic conjunctivitis,"Conjunctival infections, irritations and inflammations","Ocular infections, irritations and inflammations",Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,8,No,No
120-039,6001,1,upper respiratory tract infection,22.1,Infections and infestations,Upper respiratory tract infection,Upper respiratory tract infection,Upper respiratory tract infections,Infections - pathogen unspecified,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-039,6002,2,increase creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,7,No,No
120-037,6001,1,moderate headache,22.1,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-037,6002,2,headache,22.1,Nervous system disorders,Headache,Headache,Headaches NEC,Headaches,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-037,6003,3,myalgia of both calf muscles,22.1,Musculoskeletal and connective tissue disorders,Myalgia,Myalgia of lower extremities,Muscle pains,Muscle disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4.1,No,No
120-037,6004,4,cough,22.1,"Respiratory, thoracic and mediastinal disorders",Cough,Cough,Coughing and associated symptoms,Respiratory disorders NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-087,6001,1,common cold,22.1,Infections and infestations,Nasopharyngitis,Common cold,Upper respiratory tract infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,2.1,No,No
120-087,6002,2,feeling tiredness,22.1,General disorders and administration site conditions,Fatigue,Tiredness,Asthenic conditions,General system disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-087,6003,3,numbness of left injection site,22.1,General disorders and administration site conditions,Injection site hypoaesthesia,Injection site numbness,Injection site reactions,Administration site reactions,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2.1,No,No
120-087,6004,4,tenderness on left shoulder and left wrist,22.1,General disorders and administration site conditions,Tenderness,Tenderness,Pain and discomfort NEC,General system disorders NEC,Moderate,Moderate,Related,Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4.1,No,No
120-103,6001,1,anal pruritus,22.1,Gastrointestinal disorders,Anal pruritus,Anal pruritus,Anal and rectal signs and symptoms,Anal and rectal conditions NEC,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,3,No,No
120-103,6002,2,lack of taste sensation,22.1,Nervous system disorders,Ageusia,Loss of taste,Sensory abnormalities NEC,Neurological disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-103,6005,5,symptomatic bacterial vaginosis,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-045,6001,1,respiratory tract infection,22.1,Infections and infestations,Respiratory tract infection,Respiratory tract infection,Infections NEC,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,5.1,No,No
120-108,6001,1,cough,22.1,"Respiratory, thoracic and mediastinal disorders",Cough,Cough,Coughing and associated symptoms,Respiratory disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,2.1,No,No
120-108,6002,2,lower back pain,22.1,Musculoskeletal and connective tissue disorders,Back pain,Low back pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,2.1,No,No
120-068,6001,1,pityriasis vericolor,22.1,Infections and infestations,Tinea versicolour,Pityriasis versicolor,Tinea infections,Fungal infectious disorders,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,4,No,No
120-057,6001,1,Musculoskeletal chest pains,22.1,Musculoskeletal and connective tissue disorders,Musculoskeletal chest pain,Musculoskeletal chest pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2.1,No,No
120-057,6002,2,MILD DIZZINESS,22.1,Nervous system disorders,Dizziness,Dizziness,Neurological signs and symptoms NEC,Neurological disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2.1,No,No
120-057,6003,3,localised joint pains on both knees(bilaterally),22.1,Musculoskeletal and connective tissue disorders,Arthralgia,Knee pain,Joint related signs and symptoms,Joint disorders,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,2.1,No,No
120-005,6001,1,proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,4,No,No
120-005,6003,3,decreased neutrophils count,22.1,Investigations,Neutrophil count decreased,Neutrophil count decreased,White blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-040,6001,1,Abscess on the right cheek proximal to mouth,22.1,Infections and infestations,Subcutaneous abscess,Facial abscess,Skin structures and soft tissue infections,Infections - pathogen unspecified,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,"Medication, Procedure/Surgery",No,No,No,No,5.1,No,No
120-021,6001,1,Left side neck pain,22.1,Musculoskeletal and connective tissue disorders,Neck pain,Neck pain,Musculoskeletal and connective tissue pain and discomfort,Musculoskeletal and connective tissue disorders NEC,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,Medication,No,No,No,No,7.1,No,No
120-090,6001,1,Elevated Creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Other,No,No,No,No,10,No,No
120-106,6001,1,Elevated AST,22.1,Investigations,Aspartate aminotransferase increased,AST increased,Liver function analyses,Hepatobiliary investigations,Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,5,No,No
120-106,6002,2,Asymptomatic Bacterial Vaginosis,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,"Medication, Other",No,No,No,No,10,No,No
120-123,6001,1,Asymptomatic Bacterial Vaginosis,22.1,Infections and infestations,Bacterial vaginosis,Bacterial vaginosis,Bacterial infections NEC,Bacterial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,"Medication, Other",No,No,No,No,10,No,No
120-130,6001,1,Staphylococcus aureus urinary tract infection,22.1,Infections and infestations,Urinary tract infection staphylococcal,Urinary tract infection staphylococcal,Staphylococcal infections,Bacterial infectious disorders,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10.1,No,No
120-144,6001,1,Reduced haemoglobin,22.1,Investigations,Haemoglobin decreased,Decreased haemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,No change,No change,Resolved,Resolved,"Medication, Other",No,No,No,No,7,No,No
120-144,6002,2,Reduced haemoglobin,22.1,Investigations,Haemoglobin decreased,Decreased haemoglobin,Red blood cell analyses,Haematology investigations (incl blood groups),Mild,Mild,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,Medication,No,No,No,No,10,No,No
120-105,6001,1,Proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-044,6001,1,Elevated Creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,No change,No change,Resolved,Resolved,None,No,No,No,No,3,No,No
120-025,6001,1,Proteinuria,22.1,Renal and urinary disorders,Proteinuria,Proteinuria,Urinary abnormalities,Urinary tract signs and symptoms,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No
120-025,6002,2,Elevated creatinine,22.1,Investigations,Blood creatinine increased,Creatinine increased,Renal function analyses,Renal and urinary tract investigations and urinalyses,Moderate,Moderate,Not Related,Not Related,Permanently Discontinued,Permanently Discontinued,Resolved,Resolved,None,No,No,No,No,10,No,No