Adverse Events Module

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 @ 12:32 AM
Ignite Modification Date: 2025-12-25 @ 10:40 PM
NCT ID: NCT03148067
Description: 26 cases of infection were observed after 12 months of follow-up. One patient died from infection.
Frequency Threshold: 5
Time Frame: 18 months
Study: NCT03148067
Study Brief: Incidence and Risk Factors for Surgical Site Infection After Intramedullary Nailing of Femoral and Tibial Fractures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Patients 221 Patients with closed or open diaphyseal femoral and tibial fractures treated through intramedullary nailing for fracture fixation were included and completed follow up Intramedullary nailing for fracture fixation 1 None 26 221 0 221 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgical site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other Events(If Any):