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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT03721835
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from the time of surgery through the 1 year follow-up
Study: NCT03721835
Study Brief: Safety Study of Femoral Neck Fracture System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Femoral Neck Fracture System This is a single arm study of subjects who are to be implanted with the CONQUEST FN™Femoral Neck Fracture System for treatment of a trauma related femoral neck fracture CONQUEST FN Femoral Neck Fracture System: Fracture fixation device consisting of a single plate and three screws 1 None 5 15 3 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Screw fracture (Posterior, Proximal), Screw back out (Anterior, Proximal) NON_SYSTEMATIC_ASSESSMENT Product Issues None View
End stage Parkinson's Disease NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
St. Elevation Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Foot infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Non union NON_SYSTEMATIC_ASSESSMENT Product Issues None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Closed head injury NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Redness to right foot NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ground level fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View