Adverse Events Module

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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 @ 3:53 AM
Ignite Modification Date: 2025-12-26 @ 2:42 AM
NCT ID: NCT01994902
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01994902
Study Brief: Investigation of Newly Developed Ostomy Products in Subjects With Ileostomy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Coloplast Test Product Adverse events reported by subjects testing Coloplast test product None None 6 125 28 125 View
SenSura Convex Light Adverse events reported by subjects testing SenSura Convex Light None None 3 120 14 120 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
acute abdominal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrientitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
stoma operation (revision of stome) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
obstruction of stoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Blocked stoma SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dehydration SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Severe sepsis in contex of intra abdominal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin irritations SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View