MedDRA Level (0-5),Most Severe (text),Most Related (text),Data Description #1,MedDRA text SOC,MedDRA text Preferred,pub_id,rx,rx_code,summary_level
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Herpangina,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Proteinuria,104-79,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Ear and labyrinth disorders,,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Ear and labyrinth disorders,Ear congestion,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Sinusitis,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Lymphocyte count decreased,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Eczema,104-53,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-31,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-31,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Pharyngitis,104-31,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,Lymph node pain,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Constipation,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site bruising,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site pruritus,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Furuncle,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Ligament sprain,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Skin mass,104-72,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site bruising,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Sinusitis,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Sunburn,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-70,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site pruritus,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Muscle rupture,104-67,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site bruising,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Rash maculo-papular,104-30,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-66,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-66,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Haemorrhoids,104-66,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-66,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Somnolence,104-66,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Proctalgia,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Laceration,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,104-16,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-81,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-81,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-81,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Heart rate irregular,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Haematuria,104-33,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Nausea,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Procedural pain,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Acrochordon,104-88,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral upper respiratory tract infection,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-45,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastroenteritis viral,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Headache,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Hypoaesthesia,104-60,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Fatigue,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Nasopharyngitis,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Otitis media,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Syncope,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,Insomnia,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,Dysmenorrhoea,104-39,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastroenteritis viral,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Neoplasms benign, malignant and unspecified (incl cysts and polyps)",Skin papilloma,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Hyperaesthesia,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Proteinuria,104-73,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Related,AE Summary Data Excluding Reactogenicity Events,,,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Sinusitis,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Blood creatinine increased,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Dermatitis contact,104-23,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Related,AE Summary Data Excluding Reactogenicity Events,,,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-10,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injury associated with device,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Nasopharyngitis,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Respiratory tract infection viral,104-03,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastroenteritis,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastroenteritis viral,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Tinea infection,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral upper respiratory tract infection,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Myalgia,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Pityriasis rosea,104-22,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-76,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-76,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Migraine,104-76,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-76,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Skin mass,104-76,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-75,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastroenteritis,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Pharyngitis streptococcal,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-43,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Myalgia,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Pain in extremity,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,Insomnia,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Night sweats,104-37,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Proteinuria,104-61,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-57,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-57,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Back pain,104-57,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-35,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-35,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Haematuria,104-35,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-82,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,,104-82,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,Neutropenia,104-82,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Proctalgia,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Rectal haemorrhage,104-28,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Back injury,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Neutrophil count decreased,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Papule,104-85,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Toothache,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Tooth fracture,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Musculoskeletal pain,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Headache,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,Dysmenorrhoea,104-48,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-44,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-44,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-44,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Suprapubic pain,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urinary tract infection,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Reproductive system and breast disorders,Vulvovaginal pruritus,104-49,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-58,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-58,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Laryngitis,104-58,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-58,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Pain in jaw,104-58,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Hangover,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Limb injury,104-09,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Influenza like illness,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Rash papular,104-55,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Laceration,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Dizziness,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Presyncope,104-14,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-46,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-46,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-46,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-36,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-36,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-36,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-54,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Food poisoning,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Hangover,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Papule,104-74,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-01,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-01,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Neutrophil count decreased,104-01,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-27,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-27,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Herpes zoster,104-27,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-27,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Arthropod bite,104-27,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Arthropod bite,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Laceration,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Blood creatinine increased,104-63,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-12,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-12,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-12,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Blood alkaline phosphatase increased,104-12,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Vulvovaginal candidiasis,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Neutrophil count decreased,104-84,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Related,AE Summary Data Excluding Reactogenicity Events,,,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Tooth abscess,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Rash generalised,104-17,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Related,AE Summary Data Excluding Reactogenicity Events,,,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Injection site pruritus,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Impetigo,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Proteinuria,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Dermatitis contact,104-34,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,Neutropenia,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Chest pain,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Limb injury,104-80,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Bacterial vaginosis,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Vaginitis bacterial,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Vulvovaginal candidiasis,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Dysuria,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Micturition urgency,104-04,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Gastrointestinal viral infection,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-13,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Related,AE Summary Data Excluding Reactogenicity Events,,,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,Participant
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Chest discomfort,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Bacteriuria,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-47,Placebo for VRC01 IV mo(0) + SC mo(0.5 to 5.5 by 0.5),P3,"Participant, MedDRA Preferred Term"
0,Mild,Related,AE Summary Data Excluding Reactogenicity Events,,,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,Neutropenia,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Toothache,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-26,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Severe,Related,AE Summary Data Excluding Reactogenicity Events,,,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Varicella zoster virus infection,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Psychiatric disorders,Depression,104-32,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-38,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-38,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Influenza like illness,104-38,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-77,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-77,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-77,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-77,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Liver function test increased,104-77,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Blood and lymphatic system disorders,Anaemia,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Constipation,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-41,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Musculoskeletal and connective tissue disorders,Tendonitis,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Nervous system disorders,Headache,104-50,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-24,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-24,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Pharyngitis,104-24,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",,104-24,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Injury, poisoning and procedural complications",Traumatic iritis,104-24,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,General disorders and administration site conditions,Peripheral swelling,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Upper respiratory tract infection,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Erythema,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Generalised erythema,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Pruritus,104-19,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Toothache,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Urethritis gonococcal,104-69,VRC01 40mg/kg IV mo(0) + 5mg/kg SC mo(0.5 to 5.5 by 0.5),T3,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-86,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-86,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Pharyngitis streptococcal,104-86,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-20,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-20,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-20,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Mild,Related,AE Summary Data Excluding Reactogenicity Events,,,104-18,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-18,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Diarrhoea,104-18,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Severe,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Influenza,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Alanine aminotransferase increased,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Respiratory, thoracic and mediastinal disorders",,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Respiratory, thoracic and mediastinal disorders",Sinus congestion,104-52,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Aspartate aminotransferase increased,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Respiratory, thoracic and mediastinal disorders",,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,"Respiratory, thoracic and mediastinal disorders",Sinus congestion,104-71,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,Participant
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Viral infection,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Skin and subcutaneous tissue disorders,Pruritus,104-78,"VRC01 40mg/kg mo(0) + 20mg/kg mo(1,2,3,4,5)",T1,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-68,"VRC01 40mg/kg mo(0,2,4)",T2,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,,104-68,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Investigations,Haemoglobin decreased,104-68,"VRC01 40mg/kg mo(0,2,4)",T2,"Participant, MedDRA Preferred Term"
0,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Gastrointestinal disorders,Anal pruritus,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
1,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA System Organ Class"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Acarodermatitis,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
4,Moderate,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Herpes simplex,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Infections and infestations,Nasopharyngitis,104-15,"VRC01 10mg/kg mo(0,2,4)",T4,"Participant, MedDRA Preferred Term"
0,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,,,104-51,"VRC01 30mg/kg mo(0,2,4)",T5,Participant
1,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,,104-51,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA System Organ Class"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Ketonuria,104-51,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"
4,Mild,Not Related,AE Summary Data Excluding Reactogenicity Events,Renal and urinary disorders,Leukocyturia,104-51,"VRC01 30mg/kg mo(0,2,4)",T5,"Participant, MedDRA Preferred Term"