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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT02675634
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from subject enrollment to the subject left the study. Subjects with serious adverse events were followed until their condition was resolved.
Study: NCT02675634
Study Brief: Investigation of Two New 1-piece Ostomy Products in People With an Ileostomy or Colostomy
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 B This is the results from all the subjects evaluating Test B None None 0 54 11 54 View
Own Product this is the result from all the subjects evaluating Own product. None None 0 51 4 51 View
Test A This is the result from all subjects evaluating Test A None None 1 52 8 52 View
Serious Events(If Any):

Serious Events

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

Other Events

Term Type Organ System Vocab View
Peristomal skin dermatitis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View