"Number of days onset post-SPA","Closest Previous SPA No.","Severity","Relationship to Study Product","Is AE Record MedDRA Coded? (0/1)","Duration of AE in Days","Study Day of Onset (derived)","Study Day of Outcome (derived)","Treatment","MedDRA flagversion","MedDRA text Preferred","MedDRA text SOC","Adverse Experience (AE)","Status/Outcome","SAE according to ICH?","Reported as EAE?","Visit Code Reported","pub_id","rx","rx_code"
0,2,Mild,Not Related,1,18,14,31,None,U~19.0,Haemoglobin decreased,Investigations,Lowered Hemoglobin,Resolved,No,No,4,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,2,Mild,Not Related,1,18,14,31,None,U~19.0,Proteinuria,Renal and urinary disorders,Proteinuria 1+,Resolved,No,No,4,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,5,Mild,Not Related,1,6,68,73,Medication,E~19.0,Herpangina,Infections and infestations,Herpangina,Resolved,No,No,11,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
9,6,Mild,Not Related,1,13,79,91,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,11.1,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
23,11,Mild,Not Related,1,10,160,169,Medication,E~19.0,Viral infection,Infections and infestations,Viral Syndrome,Resolved,No,No,18,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
17,1,Mild,Not Related,1,5,17,21,Medication,E~19.0,Sinusitis,Infections and infestations,sinusitis,Resolved,No,No,6,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
9,2,Mild,Not Related,1,3,37,39,Medication,U~19.0,Ear congestion,Ear and labyrinth disorders,R ear congestion,Resolved,No,No,8,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
21,2,Mild,Not Related,1,2,49,50,Medication,E~19.0,Viral infection,Infections and infestations,viral syndrome,Resolved,No,No,9,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
34,4,Mild,Not Related,1,21,121,141,Medication,U~19.0,Eczema,Skin and subcutaneous tissue disorders,eczema dorsal aspect L + R forearm,Resolved,No,No,16,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
49,4,Mild,Not Related,1,3,136,138,Medication,U~19.0,Viral infection,Infections and infestations,viral syndrome,Resolved,No,No,16,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,3,Mild,Not Related,1,32,56,87,None,U~19.0,Lymphocyte count decreased,Investigations,Lymphocytes decreased,Resolved,No,No,9,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
146,2,Mild,Not Related,1,15,199,213,Medication,E~19.0,Pharyngitis,Infections and infestations,Pharyngitis,Resolved,No,No,23,104-31,"VRC01 40mg/kg mo(0,2,4)",T2
10,1,Mild,Not Related,1,3,10,12,Medication,E~19.0,Constipation,Gastrointestinal disorders,constipation,Resolved,No,No,4,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
9,1,Mild,Not Related,1,3,9,11,None,U~19.0,Lymph node pain,Blood and lymphatic system disorders,Tender left axilla lymph node,Resolved,No,No,4,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,1,Mild,Not Related,1,11,12,22,Other,U~19.0,Furuncle,Infections and infestations,Furuncle - supra pubic midline,Resolved,No,No,4,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
3,3,Mild,Not Related,1,3,28,30,None,U~19.0,Injection site pruritus,General disorders and administration site conditions,Pruritis - R abdomen inj. site,Resolved,No,No,6.1,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
3,4,Mild,Not Related,1,18,46,63,None,U~19.0,Skin mass,Skin and subcutaneous tissue disorders,Nodule inner aspect R ear lobule,Resolved,No,No,8.1,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,9,Mild,Not Related,1,7,110,116,None,U~19.0,Injection site bruising,General disorders and administration site conditions,Bruise 1cm x 1cm at injection site,Resolved,No,No,14.1,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
7,10,Moderate,Not Related,1,10,133,142,Other,U~19.0,Ligament sprain,"Injury, poisoning and procedural complications",R thumb sprain,Resolved,No,No,16,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
69,11,Mild,Not Related,1,,209,,Other,U~19.0,Ligament sprain,"Injury, poisoning and procedural complications",L index finger sprain,Continuing at End of Study,No,No,23,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
4,1,Mild,Not Related,1,6,4,9,None,E~19.0,Sinusitis,Infections and infestations,Sinusitis,Resolved,No,No,3,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
0,2,Mild,Not Related,1,44,16,59,None,E~19.0,Haemoglobin decreased,Investigations,decreased hemoglobin,Resolved,No,No,4,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
3,9,Mild,Not Related,1,3,115,117,None,U~19.0,Injection site bruising,General disorders and administration site conditions,bruise at injection site L side,Resolved,No,No,14.1,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
15,9,Mild,Not Related,1,12,127,138,Medication,E~19.0,Viral infection,Infections and infestations,viral syndrome,Resolved,No,No,15,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
68,11,Mild,Not Related,1,5,210,214,"Medication, Other",U~19.0,Sunburn,"Injury, poisoning and procedural complications",Sunburn,Resolved,No,No,23,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
7,2,Moderate,Not Related,1,25,21,45,"Medication, Other",U~19.0,Muscle rupture,"Injury, poisoning and procedural complications",Presumptive tear to Sartorius muscle L Leg,Resolved,No,No,6,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,9,Mild,Not Related,1,9,120,128,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,15,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,10,Mild,Not Related,1,12,128,139,None,U~19.0,Injection site pruritus,General disorders and administration site conditions,Pruritus bilateral injection sites,Resolved,No,No,16,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
4,3,Mild,Not Related,1,5,30,34,None,E~19.0,Viral infection,Infections and infestations,viral syndrome,Resolved,No,No,6.1,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
36,6,Mild,Not Related,1,5,104,108,Medication,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,14,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,9,Mild,Not Related,1,7,109,115,None,U~19.0,Injection site bruising,General disorders and administration site conditions,BRUISE AT LEFT INJECTION SITE,Resolved,No,No,14.1,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,10,Mild,Not Related,1,10,123,132,None,U~19.0,Injection site bruising,General disorders and administration site conditions,Left and Right injection site bruise,Resolved,No,No,15.1,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,11,Mild,Not Related,1,7,137,143,None,U~19.0,Injection site bruising,General disorders and administration site conditions,Bruise R injection site,Resolved,No,No,16.1,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
5,11,Moderate,Not Related,1,3,142,144,Medication,E~19.0,Urinary tract infection,Infections and infestations,UTI,Resolved,No,No,16.2,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
1,11,Mild,Not Related,1,28,138,165,Medication,U~19.0,Rash maculo-papular,Skin and subcutaneous tissue disorders,Maculopapular rash upper extremities and intergluteal cleft,Resolved,No,No,17,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
27,11,Mild,Not Related,1,13,164,176,Medication,E~19.0,Urinary tract infection,Infections and infestations,UTI,Resolved,No,No,19,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
38,11,Mild,Not Related,1,36,175,210,Medication,U~19.0,Rash maculo-papular,Skin and subcutaneous tissue disorders,maculopapular rash upper extremities,Resolved,No,No,19.1,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
46,2,Mild,Not Related,1,,102,,Medication,E~19.0,Haemorrhoids,Gastrointestinal disorders,Hemorrhoids,Continuing at End of Study,No,No,14,104-66,"VRC01 40mg/kg mo(0,2,4)",T2
135,2,Moderate,Not Related,1,,191,,None,E~19.0,Somnolence,Nervous system disorders,Somnolence,Continuing at End of Study,No,No,23,104-66,"VRC01 40mg/kg mo(0,2,4)",T2
0,2,Mild,Not Related,1,1,57,57,None,U~19.0,Proctalgia,Gastrointestinal disorders,Pain - rectum,Resolved,No,No,10,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
2,2,Mild,Not Related,1,2,59,60,None,U~19.0,Musculoskeletal pain,Musculoskeletal and connective tissue disorders,Pain R Shoulder,Resolved,No,No,10,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
38,3,Mild,Not Related,1,15,150,164,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,19,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
54,3,Mild,Not Related,1,15,166,180,Other,U~19.0,Laceration,"Injury, poisoning and procedural complications",1 cm laceration index finger right hand,Resolved,No,No,19,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
66,3,Mild,Not Related,1,8,178,185,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,21,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
87,3,Mild,Not Related,1,10,199,208,Other,U~19.0,Laceration,"Injury, poisoning and procedural complications",1 cm laceration thumb right hand,Resolved,No,No,21,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
95,3,Mild,Not Related,1,,207,,None,U~19.0,Upper respiratory tract infection,Infections and infestations,URI with cough,Continuing at End of Study,No,No,22,104-16,"VRC01 10mg/kg mo(0,2,4)",T4
13,1,Moderate,Not Related,1,8,13,20,Medication,E~19.0,Viral infection,Infections and infestations,Viral Syndrome,Resolved,No,No,4,104-81,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
3,1,Mild,Not Related,1,2,3,4,None,U~19.0,Heart rate irregular,Investigations,irregular heart beat on auscultation,Resolved,No,No,3,104-33,"VRC01 10mg/kg mo(0,2,4)",T4
55,3,Mild,Not Related,1,15,165,179,Medication,E~19.0,Viral infection,Infections and infestations,viral syndrome,Resolved,No,No,19,104-33,"VRC01 10mg/kg mo(0,2,4)",T4
57,3,Moderate,Not Related,1,13,167,179,None,E~19.0,Haematuria,Renal and urinary disorders,hematuria,Resolved,No,No,19,104-33,"VRC01 10mg/kg mo(0,2,4)",T4
7,1,Mild,Not Related,1,3,7,9,Medication,E~19.0,Nausea,Gastrointestinal disorders,Nausea,Resolved,No,No,3.1,104-88,"VRC01 30mg/kg mo(0,2,4)",T5
73,1,Mild,Not Related,1,1,73,73,None,U~19.0,Acrochordon,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Skin tag removed L axilla,Resolved,No,No,12,104-88,"VRC01 30mg/kg mo(0,2,4)",T5
24,3,Mild,Not Related,1,59,140,198,Medication,U~19.0,Procedural pain,"Injury, poisoning and procedural complications",Pain left foot after plantar wart destruction,Resolved,No,No,16,104-88,"VRC01 30mg/kg mo(0,2,4)",T5
1,1,Mild,Not Related,1,7,1,7,Medication,U~19.0,Urinary tract infection,Infections and infestations,UTI,Resolved,No,No,3,104-45,"VRC01 30mg/kg mo(0,2,4)",T5
4,2,Moderate,Not Related,1,15,62,76,None,U~19.0,Viral upper respiratory tract infection,Infections and infestations,Viral URI,Resolved,No,No,11,104-45,"VRC01 30mg/kg mo(0,2,4)",T5
0,3,Mild,Not Related,1,30,112,141,None,U~19.0,Haemoglobin decreased,Investigations,Decreased hemoglobin 10.9g/dL,Resolved,No,No,14,104-45,"VRC01 30mg/kg mo(0,2,4)",T5
1,3,Mild,Not Related,1,8,113,120,None,U~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,14.1,104-45,"VRC01 30mg/kg mo(0,2,4)",T5
58,3,Mild,Not Related,1,44,170,213,None,U~19.0,Haemoglobin decreased,Investigations,Lowered Hemoglobin,Resolved,No,No,19,104-45,"VRC01 30mg/kg mo(0,2,4)",T5
7,1,Moderate,Not Related,1,1,7,7,Medication,E~19.0,Headache,Nervous system disorders,headache,Resolved,No,No,4,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
10,1,Moderate,Not Related,1,1,10,10,Medication,E~19.0,Headache,Nervous system disorders,headache,Resolved,No,No,4,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
14,2,Moderate,Not Related,1,6,43,48,Medication,E~19.0,Gastroenteritis viral,Infections and infestations,viral gastroenteritis,Resolved,No,No,9,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,3,Mild,Not Related,1,1,55,55,None,U~19.0,Hypoaesthesia,Nervous system disorders,"numbness in middle, ring, and pinky fingers (left hand)",Resolved,No,No,9,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
28,1,Mild,Not Related,1,28,28,55,None,S~19.0,Aspartate aminotransferase increased,Investigations,elevated AST,Resolved,No,No,6,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
28,1,Mild,Not Related,1,28,28,55,None,S~19.0,Alanine aminotransferase increased,Investigations,Elevated ALT,Resolved,No,No,6,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
10,2,Moderate,Not Related,1,9,38,46,Medication,E~19.0,Urinary tract infection,Infections and infestations,Urinary Tract Infection,Resolved,No,No,9,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
21,2,Moderate,Not Related,1,17,49,65,Medication,E~19.0,Nasopharyngitis,Infections and infestations,Common Cold,Resolved,No,No,9,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,4,Moderate,Not Related,1,1,86,86,Medication,U~19.0,Syncope,Nervous system disorders,Vasovagal syncope,Resolved,No,No,12,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
19,4,Mild,Not Related,1,11,105,115,None,U~19.0,Fatigue,General disorders and administration site conditions,Fatigue (related to life schedule),Resolved,No,No,14,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
19,4,Mild,Not Related,1,11,105,115,None,E~19.0,Insomnia,Psychiatric disorders,Difficulty sleeping,Resolved,No,No,14,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
21,4,Mild,Not Related,1,9,107,115,None,U~19.0,Dysmenorrhoea,Reproductive system and breast disorders,Right upper quadrant abdominal tenderness secondary to menses,Resolved,No,No,14,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
40,4,Moderate,Not Related,1,10,126,135,Medication,E~19.0,Otitis media,Infections and infestations,Otitis Media,Resolved,No,No,16,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
24,4,Mild,Not Related,1,2,110,111,None,E~19.0,Gastroenteritis viral,Infections and infestations,Viral Gastroenteritis,Resolved,No,No,14,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
26,5,Mild,Not Related,1,3,140,142,None,U~19.0,Hyperaesthesia,Nervous system disorders,TACTILE SENSITIVITY (LEFT THIGH/SKIN),Resolved,No,No,16,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
28,6,Mild,Not Related,1,51,170,220,None,U~19.0,Proteinuria,Renal and urinary disorders,Proteinuria (mild),Resolved,No,No,19,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
30,6,Mild,Not Related,1,,172,,None,U~19.0,Skin papilloma,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",2 plantar warts on right foot,Continuing at End of Study,No,No,23,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
14,1,Mild,Related,1,15,14,28,None,U~19.0,Blood creatinine increased,Investigations,creatinine elevation,Resolved,No,No,4,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
14,4,Moderate,Not Related,1,21,98,118,Medication,U~19.0,Dermatitis contact,Skin and subcutaneous tissue disorders,"Contact Dermatitis (inner, upper thighs bilaterally, left forearm)",Resolved,No,No,12.1,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
7,5,Moderate,Not Related,1,23,119,141,Medication,E~19.0,Sinusitis,Infections and infestations,sinusitis,Resolved,No,No,16,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
11,1,Moderate,Not Related,1,25,11,35,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,4,104-10,"VRC01 40mg/kg mo(0,2,4)",T2
13,1,Mild,Related,1,44,13,56,None,S~19.0,Aspartate aminotransferase increased,Investigations,elevated AST,Resolved,No,No,4,104-10,"VRC01 40mg/kg mo(0,2,4)",T2
13,1,Mild,Related,1,44,13,56,None,S~19.0,Alanine aminotransferase increased,Investigations,elevated ALT,Resolved,No,No,4,104-10,"VRC01 40mg/kg mo(0,2,4)",T2
49,1,Moderate,Not Related,1,6,49,54,Medication,U~19.0,Respiratory tract infection viral,Infections and infestations,viral respiratory infection,Resolved,No,No,9,104-03,"VRC01 40mg/kg mo(0,2,4)",T2
40,3,Moderate,Not Related,1,5,154,158,Medication,E~19.0,Nasopharyngitis,Infections and infestations,common cold,Resolved,No,No,19,104-03,"VRC01 40mg/kg mo(0,2,4)",T2
94,3,Moderate,Not Related,1,1,208,208,Medication,U~19.0,Injury associated with device,General disorders and administration site conditions,occupational percutaneous needle puncture wound of finger due to a hypodermic needle,Resolved,No,No,22,104-03,"VRC01 40mg/kg mo(0,2,4)",T2
0,1,Mild,Not Related,1,13,0,12,None,U~19.0,Viral upper respiratory tract infection,Infections and infestations,upper respiratory infection viral,Resolved,No,No,3,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
8,2,Moderate,Not Related,1,5,35,39,Medication,U~19.0,Myalgia,Musculoskeletal and connective tissue disorders,MUSCLE PAIN IN NECK AND LEFT SIDE OF UPPER BACK,Resolved,No,No,8,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
40,2,Moderate,Not Related,1,3,67,69,None,E~19.0,Gastroenteritis viral,Infections and infestations,stomach flu,Resolved,No,No,12,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
66,2,Mild,Not Related,1,20,93,112,None,E~19.0,Urinary tract infection,Infections and infestations,Urinary Tract Infection,Resolved,No,No,12.1,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
62,2,Moderate,Not Related,1,6,89,94,Medication,U~19.0,Viral upper respiratory tract infection,Infections and infestations,Upper Respiratory Viral Infection,Resolved,No,No,12.1,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
83,2,Mild,Not Related,1,2,110,111,Medication,E~19.0,Gastroenteritis,Infections and infestations,Gastroenteritis,Resolved,No,No,14,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
17,5,Mild,Not Related,1,91,134,224,Medication,U~19.0,Pityriasis rosea,Skin and subcutaneous tissue disorders,"Pityriasis Rosea (neck, arms, torso)",Resolved,No,No,16,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
83,6,Mild,Not Related,1,6,224,229,None,U~19.0,Tinea infection,Infections and infestations,ringworm,Resolved,No,No,23,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
10,3,Moderate,Not Related,1,1,118,118,None,E~19.0,Migraine,Nervous system disorders,Migraine,Resolved,No,No,14,104-76,"VRC01 40mg/kg mo(0,2,4)",T2
103,3,Mild,Not Related,1,10,211,220,None,U~19.0,Skin mass,Skin and subcutaneous tissue disorders,Neck Nodule (right side of neck),Resolved,No,No,23,104-76,"VRC01 40mg/kg mo(0,2,4)",T2
24,4,Mild,Not Related,1,44,105,148,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,16,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
23,6,Mild,Not Related,1,17,161,177,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,19,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
75,6,Mild,Not Related,1,,213,,None,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Continuing at End of Study,No,No,23,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
50,1,Moderate,Not Related,1,4,50,53,Medication,U~19.0,Pharyngitis streptococcal,Infections and infestations,strep throat,Resolved,No,No,9,104-43,"VRC01 40mg/kg mo(0,2,4)",T2
13,2,Moderate,Not Related,1,2,69,70,Other,E~19.0,Gastroenteritis,Infections and infestations,gastroenteritis,Resolved,No,No,12,104-43,"VRC01 40mg/kg mo(0,2,4)",T2
57,3,Mild,Not Related,1,56,168,223,None,E~19.0,Haemoglobin decreased,Investigations,Decreased hemoglobin,Resolved,No,No,19,104-43,"VRC01 40mg/kg mo(0,2,4)",T2
0,1,Mild,Not Related,1,2,0,1,None,U~19.0,Pain in extremity,Musculoskeletal and connective tissue disorders,right thigh pain,Resolved,No,No,2,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
26,1,Mild,Not Related,1,21,26,46,Medication,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,6,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
19,2,Mild,Not Related,1,19,47,65,None,E~19.0,Insomnia,Psychiatric disorders,insomnia,Resolved,No,No,9,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
12,3,Mild,Not Related,1,23,68,90,Medication,U~19.0,Myalgia,Musculoskeletal and connective tissue disorders,generalized myalgia,Resolved,No,No,12,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
20,3,Mild,Not Related,1,2,76,77,None,E~19.0,Night sweats,Skin and subcutaneous tissue disorders,night sweats,Resolved,No,No,12,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
32,6,Mild,Not Related,1,8,168,175,None,U~19.0,Proteinuria,Renal and urinary disorders,Proteinuria 1+,Resolved,No,No,19,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
32,6,Severe,Not Related,1,11,168,178,None,S~19.0,Aspartate aminotransferase increased,Investigations,Elevated AST,Resolved,No,No,19,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
32,6,Severe,Not Related,1,24,168,191,None,S~19.0,Alanine aminotransferase increased,Investigations,Elevated ALT,Resolved,No,No,19,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
93,3,Moderate,Not Related,1,9,205,213,Medication,U~19.0,Back pain,Musculoskeletal and connective tissue disorders,lower back pain,Resolved,No,No,22,104-57,"VRC01 40mg/kg mo(0,2,4)",T2
6,2,Mild,Not Related,1,9,19,27,None,E~19.0,Haematuria,Renal and urinary disorders,microscopic hematuria,Resolved,No,No,5.1,104-35,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,3,Mild,Not Related,1,29,111,139,None,E~19.0,Neutropenia,Blood and lymphatic system disorders,Neutropenia,Resolved,No,No,14,104-82,"VRC01 30mg/kg mo(0,2,4)",T5
7,8,Moderate,Not Related,1,4,108,111,None,E~19.0,Proctalgia,Gastrointestinal disorders,Rectal Pain,Resolved,No,No,14,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
10,8,Mild,Not Related,1,4,111,114,None,E~19.0,Rectal haemorrhage,Gastrointestinal disorders,rectal bleeding,Resolved,No,No,14,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
7,5,Mild,Not Related,1,8,63,70,None,U~19.0,Papule,Skin and subcutaneous tissue disorders,erythematous papules on abdomen,Resolved,No,No,11,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
10,10,Mild,Not Related,1,8,136,143,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper respiratory infection,Resolved,No,No,16,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,9,Mild,Not Related,1,29,112,140,None,U~19.0,Neutrophil count decreased,Investigations,Decreased absolute neutrophils count,Resolved,No,No,14,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
40,12,Moderate,Not Related,1,6,194,199,None,U~19.0,Back injury,"Injury, poisoning and procedural complications",Back injury with associated lower back pain,Resolved,No,No,21,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
13,1,Mild,Not Related,1,15,13,27,None,E~19.0,Urinary tract infection,Infections and infestations,UTI,Resolved,No,No,4,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
20,1,Moderate,Not Related,1,10,20,29,Medication,U~19.0,Toothache,Gastrointestinal disorders,Wisdom tooth pain,Resolved,No,No,6,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
13,2,Mild,Not Related,1,1,67,67,Medication,E~19.0,Headache,Nervous system disorders,headache,Resolved,No,No,11,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
29,2,Moderate,Not Related,1,1,83,83,Medication,U~19.0,Musculoskeletal pain,Musculoskeletal and connective tissue disorders,Muscle pain - R shoulder,Resolved,No,No,12,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
33,2,Severe,Not Related,1,15,87,101,"Medication, Procedure/Surgery",U~19.0,Tooth fracture,"Injury, poisoning and procedural complications",Cracked Tooth,Resolved,No,No,19,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
126,2,Mild,Not Related,1,1,180,180,Medication,E~19.0,Headache,Nervous system disorders,headache,Resolved,No,No,20,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
151,2,Moderate,Not Related,1,3,205,207,Medication,E~19.0,Dysmenorrhoea,Reproductive system and breast disorders,menstrual cramps,Resolved,No,No,22,104-48,"VRC01 30mg/kg mo(0,2,4)",T5
14,1,Mild,Not Related,1,,14,,None,S~19.0,Alanine aminotransferase increased,Investigations,elevated ALT,Continuing at End of Study,No,No,4,104-44,"VRC01 30mg/kg mo(0,2,4)",T5
27,1,Mild,Not Related,1,4,27,30,"Medication, Other",E~19.0,Urinary tract infection,Infections and infestations,urinary tract infection,Resolved,No,No,6,104-49,"VRC01 30mg/kg mo(0,2,4)",T5
24,2,Mild,Not Related,1,6,80,85,Medication,S~19.0,Upper respiratory tract infection,Infections and infestations,uri,Resolved,No,No,12,104-49,"VRC01 30mg/kg mo(0,2,4)",T5
36,3,Mild,Not Related,1,20,150,169,Medication,S~19.0,Upper respiratory tract infection,Infections and infestations,URI,Resolved,No,No,19,104-49,"VRC01 30mg/kg mo(0,2,4)",T5
73,3,Mild,Not Related,1,26,187,212,Medication,U~19.0,Suprapubic pain,General disorders and administration site conditions,suprapubic discomfort,Resolved,No,No,20,104-49,"VRC01 30mg/kg mo(0,2,4)",T5
73,3,Mild,Not Related,1,6,187,192,Medication,U~19.0,Vulvovaginal pruritus,Reproductive system and breast disorders,vaginal itching,Resolved,No,No,20,104-49,"VRC01 30mg/kg mo(0,2,4)",T5
7,2,Severe,Not Related,1,18,64,81,Medication,U~19.0,Pain in jaw,Musculoskeletal and connective tissue disorders,Jaw pain - L side,Resolved,No,No,11,104-58,"VRC01 10mg/kg mo(0,2,4)",T4
48,3,Mild,Not Related,1,10,159,168,Medication,E~19.0,Laryngitis,Infections and infestations,laryngitis,Resolved,No,No,19,104-58,"VRC01 10mg/kg mo(0,2,4)",T4
4,1,Mild,Not Related,1,2,4,5,None,E~19.0,Hangover,General disorders and administration site conditions,Hangover,Resolved,No,No,3,104-09,"VRC01 40mg/kg mo(0,2,4)",T2
2,2,Mild,Not Related,1,4,55,58,None,U~19.0,Limb injury,"Injury, poisoning and procedural complications",left fifth toe injury,Resolved,No,No,10,104-09,"VRC01 40mg/kg mo(0,2,4)",T2
60,3,Moderate,Not Related,1,13,171,183,None,U~19.0,Limb injury,"Injury, poisoning and procedural complications",R 2nd finger strain,Resolved,No,No,20,104-09,"VRC01 40mg/kg mo(0,2,4)",T2
78,3,Mild,Not Related,1,4,189,192,None,E~19.0,Viral infection,Infections and infestations,Viral Syndrome,Resolved,No,No,20,104-09,"VRC01 40mg/kg mo(0,2,4)",T2
90,3,Mild,Not Related,1,2,201,202,None,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper Respiratory infection,Resolved,No,No,22,104-09,"VRC01 40mg/kg mo(0,2,4)",T2
16,1,Mild,Not Related,1,8,16,23,None,U~19.0,Rash papular,Skin and subcutaneous tissue disorders,Papular rash on R hand & R foot,Resolved,No,No,4,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
81,6,Moderate,Not Related,1,,217,,Medication,E~19.0,Influenza like illness,General disorders and administration site conditions,flu like symptoms,Continuing at End of Study,No,No,23,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,1,Mild,Not Related,1,1,0,0,None,U~19.0,Presyncope,Nervous system disorders,Vaso vagal response to blood draw,Resolved,No,No,2,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,6,Mild,Not Related,1,4,138,141,None,U~19.0,Laceration,"Injury, poisoning and procedural complications",2mm X 2mm laceration at top of gluteal fold,Resolved,No,No,16,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
9,6,Mild,Not Related,1,41,147,187,None,E~19.0,Dizziness,Nervous system disorders,Dizziness,Resolved,No,No,17,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
57,6,Mild,Not Related,1,4,195,198,None,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper Respiratory Tract Infection,Resolved,No,No,21,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
14,3,Moderate,Not Related,1,7,123,129,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper Respiratory Infection,Resolved,No,No,16,104-46,"VRC01 40mg/kg mo(0,2,4)",T2
22,1,Mild,Not Related,1,11,22,32,None,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,6,104-36,"VRC01 40mg/kg mo(0,2,4)",T2
23,2,Mild,Not Related,1,10,77,86,None,U~19.0,Upper respiratory tract infection,Infections and infestations,Upper respiratory infection,Resolved,No,No,12,104-36,"VRC01 40mg/kg mo(0,2,4)",T2
14,1,Mild,Not Related,1,14,14,27,None,S~19.0,Alanine aminotransferase increased,Investigations,increased ALT,Resolved,No,No,4,104-54,"VRC01 30mg/kg mo(0,2,4)",T5
14,1,Moderate,Not Related,1,14,14,27,None,S~19.0,Aspartate aminotransferase increased,Investigations,increased AST,Resolved,No,No,4,104-54,"VRC01 30mg/kg mo(0,2,4)",T5
2,2,Mild,Not Related,1,3,56,58,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper Respiratory Infection,Resolved,No,No,10,104-54,"VRC01 30mg/kg mo(0,2,4)",T5
15,7,Moderate,Not Related,1,4,97,100,None,E~19.0,Food poisoning,Gastrointestinal disorders,Food poisoning,Resolved,No,No,13,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
0,9,Mild,Not Related,1,29,112,140,None,U~19.0,Alanine aminotransferase increased,Investigations,Elevated ALT (Alanine Aminotransferase),Resolved,No,No,14,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
7,12,Mild,Not Related,1,21,159,179,None,S~19.0,Alanine aminotransferase increased,Investigations,INCREASED ALT,Resolved,No,No,19,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
38,12,Moderate,Not Related,1,2,190,191,None,E~19.0,Hangover,General disorders and administration site conditions,Hangover,Resolved,No,No,21,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
38,12,Mild,Not Related,1,,190,,None,U~19.0,Papule,Skin and subcutaneous tissue disorders,Elevated papule on anus,Continuing at End of Study,No,No,21,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
12,2,Mild,Not Related,1,15,68,82,None,U~19.0,Neutrophil count decreased,Investigations,decreased neutrophils,Resolved,No,No,11,104-01,"VRC01 10mg/kg mo(0,2,4)",T4
29,1,Mild,Not Related,1,89,29,117,None,U~19.0,Arthropod bite,"Injury, poisoning and procedural complications",bug bites,Resolved,No,No,6,104-27,"VRC01 30mg/kg mo(0,2,4)",T5
74,1,Moderate,Not Related,1,7,74,80,Medication,U~19.0,Herpes zoster,Infections and infestations,Shingles (right foot),Resolved,No,No,12,104-27,"VRC01 30mg/kg mo(0,2,4)",T5
17,1,Mild,Not Related,1,29,17,45,None,U~19.0,Arthropod bite,"Injury, poisoning and procedural complications",Bed Bug Bites,Resolved,No,No,6,104-63,"VRC01 30mg/kg mo(0,2,4)",T5
0,2,Mild,Not Related,1,13,54,66,None,U~19.0,Laceration,"Injury, poisoning and procedural complications",lacerations in gluteal cleft,Resolved,No,No,9,104-63,"VRC01 30mg/kg mo(0,2,4)",T5
29,2,Mild,Not Related,1,13,83,95,None,S~19.0,Blood creatinine increased,Investigations,Elevated creatinine,Resolved,No,No,12,104-63,"VRC01 30mg/kg mo(0,2,4)",T5
0,2,Mild,Not Related,1,14,58,71,None,U~19.0,Blood alkaline phosphatase increased,Investigations,Elevated Alkaline Phosphate,Resolved,No,No,9,104-12,"VRC01 10mg/kg mo(0,2,4)",T4
0,3,Mild,Not Related,1,5,107,111,None,S~19.0,Alanine aminotransferase increased,Investigations,Elevated ALT,Resolved,No,No,14,104-12,"VRC01 10mg/kg mo(0,2,4)",T4
0,3,Mild,Not Related,1,16,28,43,None,U~19.0,Neutrophil count decreased,Investigations,decreased neutrophils,Resolved,No,No,6,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
11,10,Mild,Not Related,1,16,138,153,Medication,E~19.0,Vulvovaginal candidiasis,Infections and infestations,vaginal candidiasis,Resolved,No,No,16,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
3,2,Mild,Related,1,2,17,18,None,U~19.0,Rash generalised,Skin and subcutaneous tissue disorders,rash - generalized,Resolved,No,No,5.1,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
19,2,Moderate,Not Related,1,5,33,37,Medication,U~19.0,Tooth abscess,Infections and infestations,dental abcess,Resolved,No,No,8,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
3,3,Mild,Related,1,3,29,31,None,U~19.0,Injection site pruritus,General disorders and administration site conditions,pruritus at injection sites,Resolved,No,No,6,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,7,Moderate,Not Related,1,14,81,94,None,E~19.0,Proteinuria,Renal and urinary disorders,proteinuria,Resolved,No,No,12,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
11,9,Mild,Not Related,1,106,119,224,Medication,U~19.0,Dermatitis contact,Skin and subcutaneous tissue disorders,contact dermatitis - r face/neck,Resolved,No,No,15,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
14,12,Mild,Not Related,1,60,165,224,Medication,E~19.0,Impetigo,Infections and infestations,impetigo,Resolved,No,No,19,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,1,Mild,Not Related,1,17,12,28,Medication,U~19.0,Limb injury,"Injury, poisoning and procedural complications",traumatic injury - Left great toe,Resolved,No,No,4,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,3,Moderate,Not Related,1,7,28,34,None,E~19.0,Neutropenia,Blood and lymphatic system disorders,neutropenia,Resolved,No,No,6,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
16,7,Moderate,Not Related,1,6,100,105,None,E~19.0,Chest pain,General disorders and administration site conditions,chest pain,Resolved,No,No,13.1,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,4,Moderate,Not Related,1,17,42,58,None,E~19.0,Neutropenia,Blood and lymphatic system disorders,neutropenia,Resolved,No,No,8,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
7,2,Mild,Not Related,1,5,21,25,None,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,6,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
7,5,Mild,Not Related,1,18,63,80,None,U~19.0,Micturition urgency,Renal and urinary disorders,urgency to urinate,Resolved,No,No,11,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
7,5,Mild,Not Related,1,18,63,80,None,U~19.0,Dysuria,Renal and urinary disorders,pain with urination,Resolved,No,No,11,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
10,6,Moderate,Not Related,1,29,80,108,Medication,E~19.0,Bacterial vaginosis,Infections and infestations,bacterial vaginosis,Resolved,No,No,12,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
10,6,Moderate,Not Related,1,29,80,108,Medication,E~19.0,Vulvovaginal candidiasis,Infections and infestations,vaginal candidiasis,Resolved,No,No,12,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
49,12,Moderate,Not Related,1,,200,,Medication,U~19.0,Vaginitis bacterial,Infections and infestations,bacterial vaginitis,Continuing at End of Study,No,No,23,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
4,3,Moderate,Not Related,1,3,29,31,None,U~19.0,Gastrointestinal viral infection,Infections and infestations,GI Viral Illness,Resolved,No,No,6,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
14,9,Moderate,Not Related,1,10,123,132,None,U~19.0,Viral infection,Infections and infestations,viral illness,Resolved,No,No,15,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,2,Mild,Related,1,1,14,14,None,U~19.0,Chest discomfort,General disorders and administration site conditions,tightness in chest after SC injection,Resolved,No,No,4,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
0,2,Mild,Not Related,1,30,14,43,Medication,E~19.0,Bacteriuria,Infections and infestations,bacteriuria,Resolved,No,No,5,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
40,2,Mild,Not Related,1,10,54,63,None,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,9,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3
0,3,Mild,Not Related,1,28,28,55,None,U~19.0,Haemoglobin decreased,Investigations,Decrease in Hemoglobin > 2.5 from baseline,Resolved,No,No,6,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,9,Mild,Not Related,1,43,111,153,None,U~19.0,Haemoglobin decreased,Investigations,Drop in hemoglobin > 2.5 g/dl,Resolved,No,No,14,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
0,12,Mild,Related,1,4,153,156,None,E~19.0,Neutropenia,Blood and lymphatic system disorders,neutropenia,Resolved,No,No,17,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,12,Mild,Not Related,1,,165,,Medication,U~19.0,Toothache,Gastrointestinal disorders,dental pain - upper left molar,Continuing at End of Study,No,No,19,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
12,1,Mild,Not Related,1,10,12,21,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,4,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
2,9,Severe,Not Related,1,4,111,114,None,U~19.0,Depression,Psychiatric disorders,worsening of depression,Resolved,No,No,15,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
11,10,Mild,Not Related,1,5,134,138,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,16,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
16,11,Mild,Related,1,21,155,175,Medication,U~19.0,Varicella zoster virus infection,Infections and infestations,presumptive varicella zoster,Resolved,No,No,17,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
5,12,Severe,Not Related,1,,163,,Other,U~19.0,Depression,Psychiatric disorders,depression - worsening of pre-existing condition,Continuing at End of Study,No,No,19,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
11,7,Moderate,Not Related,1,6,96,101,Medication,E~19.0,Influenza like illness,General disorders and administration site conditions,flu-like symptoms,Resolved,No,No,13,104-38,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
44,2,Mild,Not Related,1,7,97,103,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,upper respiratory infection,Resolved,No,No,14,104-77,"VRC01 40mg/kg mo(0,2,4)",T2
0,3,Mild,Not Related,1,21,116,136,None,U~19.0,Liver function test increased,Investigations,elevated lfts,Resolved,No,No,14,104-77,"VRC01 40mg/kg mo(0,2,4)",T2
0,1,Mild,Not Related,1,5,0,4,None,E~19.0,Constipation,Gastrointestinal disorders,constipation,Resolved,No,No,3,104-41,"VRC01 40mg/kg mo(0,2,4)",T2
1,2,Mild,Not Related,1,19,54,72,None,U~19.0,Upper respiratory tract infection,Infections and infestations,"URI, sore throat, runny nose, sneezing",Resolved,No,No,10,104-41,"VRC01 40mg/kg mo(0,2,4)",T2
0,2,Mild,Not Related,1,27,53,79,None,E~19.0,Anaemia,Blood and lymphatic system disorders,anemia,Resolved,No,No,9,104-41,"VRC01 40mg/kg mo(0,2,4)",T2
5,2,Mild,Not Related,1,152,32,183,Other,U~19.0,Tendonitis,Musculoskeletal and connective tissue disorders,right patellar tendonitis,Resolved,No,No,9,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
17,4,Mild,Not Related,1,15,102,116,None,U~19.0,Headache,Nervous system disorders,headaches,Resolved,No,No,14,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
35,2,Mild,Not Related,1,6,95,100,Medication,U~19.0,Traumatic iritis,"Injury, poisoning and procedural complications",tramatic iritis - OD,Resolved,No,No,14,104-24,"VRC01 40mg/kg mo(0,2,4)",T2
14,1,Mild,Not Related,1,15,14,28,None,U~19.0,Pharyngitis,Infections and infestations,mild pharyngitis,Resolved,No,No,4,104-24,"VRC01 40mg/kg mo(0,2,4)",T2
2,2,Mild,Not Related,1,7,58,64,None,U~19.0,Erythema,Skin and subcutaneous tissue disorders,skin redness - front neck,Resolved,No,No,10,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
2,2,Mild,Not Related,1,7,58,64,None,U~19.0,Pruritus,Skin and subcutaneous tissue disorders,skin itchiness - front neck,Resolved,No,No,10,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
2,2,Mild,Not Related,1,7,58,64,None,U~19.0,Generalised erythema,Skin and subcutaneous tissue disorders,redness - left hand,Resolved,No,No,10,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
2,2,Mild,Not Related,1,7,58,64,None,U~19.0,Peripheral swelling,General disorders and administration site conditions,swelling - left hand,Resolved,No,No,10,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
13,2,Mild,Not Related,1,4,69,72,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper respiratory infection,Resolved,No,No,12,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
33,3,Mild,Not Related,1,12,146,157,Medication,E~19.0,Upper respiratory tract infection,Infections and infestations,Upper respiratory infection,Resolved,No,No,19,104-19,"VRC01 40mg/kg mo(0,2,4)",T2
7,4,Mild,Not Related,1,18,49,66,Medication,U~19.0,Toothache,Gastrointestinal disorders,dental pain - bottom left rear tooth,Resolved,No,No,9,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
6,12,Mild,Not Related,1,1,160,160,Medication,U~19.0,Urethritis gonococcal,Infections and infestations,Neisseria gonorrhoeae - urethral,Resolved,No,No,19,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3
72,3,Mild,Not Related,1,8,184,191,Medication,E~19.0,Pharyngitis streptococcal,Infections and infestations,streptococcal pharyngitis,Resolved,No,No,20,104-86,"VRC01 30mg/kg mo(0,2,4)",T5
175,1,Mild,Not Related,1,,175,,None,E~19.0,Haemoglobin decreased,Investigations,decreased hemoglobin,Continuing at End of Study,No,No,19,104-20,"VRC01 10mg/kg mo(0,2,4)",T4
2,3,Mild,Related,1,1,57,57,None,E~19.0,Diarrhoea,Gastrointestinal disorders,diarrhea,Resolved,No,No,9,104-18,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
2,1,Severe,Not Related,1,12,2,13,Medication,U~19.0,Influenza,Infections and infestations,influenza A virus infection,Resolved,No,No,3,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,2,Mild,Not Related,1,30,27,56,None,S~19.0,Aspartate aminotransferase increased,Investigations,increased AST,Resolved,No,No,6,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,2,Mild,Not Related,1,30,27,56,None,S~19.0,Alanine aminotransferase increased,Investigations,increased ALT,Resolved,No,No,6,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,4,Mild,Not Related,1,32,83,114,None,S~19.0,Alanine aminotransferase increased,Investigations,increased ALT,Resolved,No,No,12,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
25,3,Mild,Not Related,1,8,81,88,Medication,E~19.0,Sinus congestion,"Respiratory, thoracic and mediastinal disorders",sinus congestion,Resolved,No,No,12,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
24,4,Severe,Not Related,1,7,107,113,Medication,E~19.0,Influenza,Infections and infestations,Influenza B virus infection,Resolved,No,No,14,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
0,6,Mild,Not Related,1,22,140,161,None,S~19.0,Alanine aminotransferase increased,Investigations,Increased ALT,Resolved,No,No,16,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
15,1,Mild,Not Related,1,41,15,55,None,S~19.0,Aspartate aminotransferase increased,Investigations,INCREASED AST,Resolved,No,No,4,104-71,"VRC01 40mg/kg mo(0,2,4)",T2
54,3,Mild,Not Related,1,,167,,None,E~19.0,Haemoglobin decreased,Investigations,decreased hemoglobin,Continuing at End of Study,No,No,19,104-71,"VRC01 40mg/kg mo(0,2,4)",T2
111,3,Mild,Not Related,1,,224,,Medication,E~19.0,Sinus congestion,"Respiratory, thoracic and mediastinal disorders",SINUS CONGESTION,Continuing at End of Study,No,No,23,104-71,"VRC01 40mg/kg mo(0,2,4)",T2
22,1,Mild,Not Related,1,4,22,25,None,U~19.0,Pruritus,Skin and subcutaneous tissue disorders,"itching, arms, torso and back",Resolved,No,No,6,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
3,4,Moderate,Not Related,1,14,87,100,Medication,U~19.0,Viral infection,Infections and infestations,"flu like syndrome, viral infection",Resolved,No,No,12,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1
13,1,Mild,Not Related,1,74,13,86,None,E~19.0,Haemoglobin decreased,Investigations,Decreased hemoglobin,Resolved,No,No,4,104-68,"VRC01 40mg/kg mo(0,2,4)",T2
0,3,Mild,Not Related,1,62,114,175,None,E~19.0,Haemoglobin decreased,Investigations,decreased hemoglobin,Resolved,No,No,14,104-68,"VRC01 40mg/kg mo(0,2,4)",T2
21,2,Moderate,Not Related,1,32,81,112,Medication,E~19.0,Acarodermatitis,Infections and infestations,SCABIES,Resolved,No,No,11.1,104-15,"VRC01 10mg/kg mo(0,2,4)",T4
22,2,Moderate,Not Related,1,31,82,112,Medication,U~19.0,Herpes simplex,Infections and infestations,HERPES SIMPLEX VIRUS,Resolved,No,No,11.1,104-15,"VRC01 10mg/kg mo(0,2,4)",T4
49,2,Mild,Not Related,1,19,109,127,None,U~19.0,Anal pruritus,Gastrointestinal disorders,ANAL ITCHING,Resolved,No,No,14,104-15,"VRC01 10mg/kg mo(0,2,4)",T4
99,3,Mild,Not Related,1,21,211,231,Medication,E~19.0,Nasopharyngitis,Infections and infestations,COLD SYMPTOMS,Resolved,No,No,22,104-15,"VRC01 10mg/kg mo(0,2,4)",T4
63,3,Mild,Not Related,1,25,171,195,None,E~19.0,Leukocyturia,Renal and urinary disorders,LEUKOCYTURIA,Resolved,No,No,19,104-51,"VRC01 30mg/kg mo(0,2,4)",T5
63,3,Mild,Not Related,1,25,171,195,None,E~19.0,Ketonuria,Renal and urinary disorders,KETONURIA,Resolved,No,No,19,104-51,"VRC01 30mg/kg mo(0,2,4)",T5