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 @ 4:18 AM
Ignite Modification Date: 2025-12-26 @ 3:18 AM
NCT ID: NCT00677820
Description: Adverse events and SAEs were graded by severity (mild, moderate, severe) and relationship to study vaccine (none, remote, possible, probable, definite).
Frequency Threshold: 0.5
Time Frame: Solicited symptoms, AEs, and concomitant medication use were collected from administration of study vaccine through Study Day 14. Serious adverse events and SNMCs were collected from administration of study vaccine through Study Day 180.
Study: NCT00677820
Study Brief: A Prospective Study to Evaluate the Safety of a New Trivalent Intranasal Influenza Vaccine
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Trivalent Influenza Virus Vaccine Frozen trivalent vaccine containing the 3 new strains was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units (FFU) of each of 3 influenza virus strains type A/South Dakota/6/07 (H1N1), A/Uruguay/716/07 (H3N2), and B/Florida/4/2006. A single dose of investigational product was administered on Day 0. None None 3 240 12 240 View
Placebo Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer and egg allantoic fluid. A single dose of investigational product was administered on Day 0. None None 1 60 5 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Joint Sprain SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Multiple Fractures SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (11.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ear Pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA (11.1) View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Retching SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (11.1) View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (11.1) View