Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT03374202
Description: Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Frequency Threshold: 5
Time Frame: Unsolicited adverse event (AE) data collection included AEs of all severities from the date of product administration through the Day 56 (8 weeks) visit. After the Day 56 visit, only serious AEs (SAEs) and new chronic medical conditions (NCMCs) that require ongoing medical management will be recorded through the last expected LTFU visit at Year 5 (260 weeks). After all data are collected, the data reported now for the Day 56 Time Frame will be updated to reflect all post-Day 56 SAEs and NCMCs.
Study: NCT03374202
Study Brief: Safety and Tolerability of AAV8 Delivery of a Broadly Neutralizing Antibody in Adults Living With HIV: a Phase 1, Dose-escalation Trial
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Group 1: AAV8-VRC07 (5 x 10^10 vg/kg IM) AAV8-VRC07 (5 x 10\^10 vg/kg) administered by intramuscular (IM) injection (Day 0) VRC-HIVAAV070-00-GT (AAV8-VRC07): AAV8-VRC07 is a recombinant AAV vector expressing a HIV-1 CD4 binding site-specific neutralizing antibody, VRC07 0 None 0 3 2 3 View
Group 2: AAV8-VRC07 (5 x 10^11 vg/kg IM) AAV8-VRC07 (5 x 10\^11 vg/kg) administered by IM injection (Day 0) VRC-HIVAAV070-00-GT (AAV8-VRC07): AAV8-VRC07 is a recombinant AAV vector expressing a HIV-1 CD4 binding site-specific neutralizing antibody, VRC07 0 None 0 3 2 3 View
Group 3: AAV8-VRC07 (2.5 x 10^12 vg/kg IM) AAV8-VRC07 (2.5 x 10\^12 vg/kg) administered by IM injection (Day 0) VRC-HIVAAV070-00-GT (AAV8-VRC07): AAV8-VRC07 is a recombinant AAV vector expressing a HIV-1 CD4 binding site-specific neutralizing antibody, VRC07 0 None 0 4 4 4 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Aspartate aminotransferase increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 25.0 View
Upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 25.0 View
Diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 25.0 View
Administration site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 25.0 View
Myalgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 25.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 25.0 View
Blood creatinine increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 25.0 View