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 @ 1:02 AM
Ignite Modification Date: 2025-12-25 @ 11:16 PM
NCT ID: NCT01104493
Description: None
Frequency Threshold: 0.5
Time Frame: From the time that written informed consent was obtained, adverse events were collected through Study Day 15 after receipt of investigational product and serious adverse events were collected through Study Day 181 after receipt of investigational product.
Study: NCT01104493
Study Brief: A Clinical Study to Assess the Safety of a New 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
Placebo Placebo was supplied in intranasal sprayers containing 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer. A single dose of investigational product was administered on Day 1. None None 0 60 2 60 View
Monovalent Influenza Virus Vaccine Frozen monovalent vaccine containing the new strain was supplied in intranasal sprayers containing a total volume of 0.2 mL of sucrose phosphate/concentrated gelatin-arginine-glutamate buffer, egg allantoic fluid, and approximately 10\^7 fluorescent focus units of influenza virus type A/Perth/16/2009 (H3N2) virus. A single dose of investigational product was administered on Day 1. None None 3 240 6 240 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
oesophageal perforation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDraVersion 12.1 View
diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDraVersion 12.1 View
rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDraVersion 12.1 View
uterine leiomyoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDraVersion 12.1 View
menometrorrhagia SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDraVersion 12.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Sinus congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDraVersion 12.1 View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDraVersion 12.1 View
Sneezing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDraVersion 12.1 View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDraVersion 12.1 View