Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 12:04 AM
Ignite Modification Date: 2025-12-25 @ 10:03 PM
NCT ID: NCT04801758
Description: None
Frequency Threshold: 0
Time Frame: The AE reporting period is for the duration of the participant participation in this study: from study enrollment until the participant terminates. (up to 18 months)
Study: NCT04801758
Study Brief: Analytical Treatment Interruption (ATI) to Assess the Immune System's Ability to Control HIV in Participants Who Became HIV-infected During the HVTN 704/HPTN 085 AMP Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
VRC01 10mg/kg Treatment assignment in HVTN704/HPTN 085: VRC01 10mg/kg at week (0,8,16,24,32,40,48,56,64,72) 0 None 0 7 7 7 View
VRC01 30mg/kg Treatment assignment in HVTN704/HPTN 085: VRC01 30mg/kg at week (0,8,16,24,32,40,48,56,64,72) 0 None 0 5 5 5 View
Placebo Treatment assignment in HVTN704/HPTN 085: Control for VRC01 at week (0,8,16,24,32,40,48,56,64,72) 0 None 1 6 6 6 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Multiple injuries NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA 27.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MEDRA 27.1 View
Congenital cystic kidney disease NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MEDRA 27.1 View
Haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MEDRA 27.1 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MEDRA 27.1 View
Hypertransaminasaemia NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders MEDRA 27.1 View
Acute HIV infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Acute hepatitis C NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Anal chlamydia infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Furuncle NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Genitourinary tract gonococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Latent syphilis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Monkeypox NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Oral herpes NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Oropharyngeal gonococcal infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Parasitic gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Pharyngeal chlamydia infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Primary syphilis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Proctitis gonococcal NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Secondary syphilis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Urethritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Urethritis chlamydial NON_SYSTEMATIC_ASSESSMENT Infections and infestations MEDRA 27.1 View
Contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA 27.1 View
Limb injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MEDRA 27.1 View
Alanine aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Blood triglycerides increased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
CD4 lymphocytes decreased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Creatinine renal clearance decreased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Glomerular filtration rate decreased NON_SYSTEMATIC_ASSESSMENT Investigations MEDRA 27.1 View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 27.1 View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 27.1 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 27.1 View
Mixed anxiety and depressive disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MEDRA 27.1 View
Calculus urinary NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MEDRA 27.1 View
Balanoposthitis NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDRA 27.1 View
Benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MEDRA 27.1 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MEDRA 27.1 View
Acne NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 27.1 View
Alopecia NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 27.1 View
Psoriasis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MEDRA 27.1 View