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 @ 12:12 AM
Ignite Modification Date: 2025-12-25 @ 10:14 PM
NCT ID: NCT03560258
Description: Post-entry, all ≥ Grade 3 AEs, all AEs that led to a change in treatment regardless of grade, and all AEs meeting SAE definition or EAE reporting requirement, were collected. The DAIDS AE Grading Table (V2.1) and EAE Manual (V2.0) were used. All eligible participants who initiated study treatment were included.
Frequency Threshold: 0
Time Frame: From treatment initiation to study completion at Week 48 or premature study discontinuation
Study: NCT03560258
Study Brief: HIV-1-Gag Conserved-Element DNA Vaccine (p24CE) Vaccine 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
ArmA Participants received p24CE1/2 pDNA vaccine at Weeks 0 and 4, followed by p24CE1/2 pDNA admixed with full-length p55\^gag pDNA vaccine at Weeks 12 and 24. p24CE1/2 pDNA vaccine: 4 mg administered by one injection/electroporation p24CE1/2 pDNA vaccine admixed with full-length p55\^gag pDNA vaccine: 2 mg p24CE1/2 pDNA admixed with 2 mg full-length p55\^gag pDNA administered by one injection/electroporation 0 None 1 22 11 22 View
ArmB Participants received full-length p55\^gag pDNA vaccine at Weeks 0, 4, 12, and 24. Full-length p55\^gag pDNA vaccine: 4 mg full-length p55\^gag pDNA vaccine administered by one injection/electroporation 0 None 0 10 5 10 View
ArmC Participants received placebo at Weeks 0, 4, 12, and 24. Placebo: 1 mL placebo administered by one injection/electroporation 0 None 0 12 6 12 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Acute myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 24.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Creatinine renal clearance decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Glomerular filtration rate decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Muscle spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 24.0 View
Dyskinesia SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Presyncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 24.0 View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 24.0 View
Injection site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site rash SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Injection site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site bruising SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site erythema SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site pain SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site pruritus SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Vaccination site swelling SYSTEMATIC_ASSESSMENT General disorders MedDRA 24.0 View
Staphylococcal abscess SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 24.0 View
Blood bilirubin increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View
Blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations MedDRA 24.0 View