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: 2025-12-24 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT01523756
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01523756
Study Brief: A Clinical Investigation of New Ostomy Appliances
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Test Product 1 own product (baseline) - test product 1 - test product 2 test product 1 = New ostomy base plate. Due to company confidentiality the product is just called test product 1 None None 0 20 8 19 View
Test Product 2 own product (baseline) - test product 2 - test product 1 test product 2 = New ostomy base plate. Due to company confidentiality the product is just called test product 2 None None 0 20 6 18 View
Baseline Data collected on own product- All subjects collected baseline data on own product in the first period. None None 1 20 1 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Gastroenterit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin irritation (peristomal) NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Bleeding peristomal skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itchy peristomal skin NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Gastroenterit SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urin retension SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Cystitis SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
febrilia SYSTEMATIC_ASSESSMENT Infections and infestations None View
pain in bladder/Tenesmi SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
elevated prostataspecific antigen SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
cold SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
sclerose attack SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Herpes on the back of the thigh SYSTEMATIC_ASSESSMENT Infections and infestations None View
candidiacis on labia SYSTEMATIC_ASSESSMENT Infections and infestations None View