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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT04547192
Description: By the nature of their conditions, all 4,077 enrolled injured patients were at risk of death and serious adverse events.
Frequency Threshold: 0
Time Frame: Patients were followed for adverse events until 18 months, when the last enrolled patient left hospital
Study: NCT04547192
Study Brief: Improving Initial Management of the Injured at Ghanaian District and Regional Hospitals With a Trauma Intake Form
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Mortality Pre-TIF Introduction Patients who died at the study hospitals before TIF introduction. All 2,067 patients in this arm were at risk 47 None 24 2067 0 2067 View
Mortality Post-TIF Introduction Patients who died at the study hospitals after TIF introduction. All 2,010 patients in this arm were at risk 22 None 6 2010 0 2010 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
wound infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):