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 @ 3:38 AM
Ignite Modification Date: 2025-12-26 @ 2:22 AM
NCT ID: NCT00718302
Description: None
Frequency Threshold: 0
Time Frame: 2 weeks, 6 weeks, 12 weeks, 26 weeks, 52 weeks
Study: NCT00718302
Study Brief: A Multicenter Randomized Trial Comparing Antiglide and Lateral Plate Fixation in Ankle 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
Antiglide Plate A plate is placed behind the broken ankle and secured with screws None None 1 119 13 119 View
Lateral Plate A metal plate is placed to the side of the broken ankle and is secured with screws None None 1 114 8 114 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Non-Union SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
SUBJECT EXPIRED DUE TO CANCER SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
PAINFUL IMPLANT-SCREW,PLATE SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Necrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
DVT SYSTEMATIC_ASSESSMENT Vascular disorders None View
MYOCARDIAL INFARCTION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Tendonitis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Developed Equinous Contracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Loosening Hardware SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View