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: 2025-12-24 @ 1:14 PM
Ignite Modification Date: 2025-12-25 @ 12:24 PM
NCT ID: NCT03334695
Description: The full analysis set (FAS) included all participants who were randomized and received at least one dose of study vaccine, regardless of the occurrence of protocol deviations.
Frequency Threshold: 5
Time Frame: Up to 6 months post-vaccination and up to 6 months post-challenge
Study: NCT03334695
Study Brief: An Exploratory Study to Evaluate the Prophylactic Efficacy of a Single Immunization of Ad26.RSV.preF Against Respiratory Syncytial Virus Infection in a Virus Challenge Model in Healthy 18 to 50 Year-old Adults
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Post-dose: Ad26.RSV.preF (1x10^11 vp) Participants received a single intramuscular injection of 1\*10\^11 vp (viral particles) of Ad26.RSV.preF on Day -28. 0 None 0 31 4 31 View
Post-dose: Placebo Participants received a single intramuscular injection of matching placebo on Day -28. 0 None 0 32 9 32 View
Post-challenge: Challenge After Ad26.RSV.preF Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of 1x1011 vp of Ad26.RSV.preF on Day -28. 0 None 1 27 16 27 View
Post-challenge: Challenge After Placebo Participants undergone intranasal challenge with RSV-A Memphis 37b virus on Day 0, after receiving single intramuscular doses of placebo on Day -28. 0 None 0 26 16 26 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Ovarian Cyst NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA Version 21.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Lymphadenopathy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 21.0 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 21.0 View
Pharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 21.0 View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA Version 21.0 View
Alanine Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Aspartate Aminotransferase Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Troponin T Increased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 21.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 21.0 View
Epistaxis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
Rhinorrhoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA Version 21.0 View
Dry Skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA Version 21.0 View