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 @ 1:43 AM
Ignite Modification Date: 2025-12-26 @ 12:00 AM
NCT ID: NCT04118894
Description: Procedural and device related events will be described and collected on the AE form. It is the responsibility of the operating surgeon/s to be aware and note the adverse effects from the package insert/instructions for use by the manufacturer/sponsor.
Frequency Threshold: 0
Time Frame: Surgery to 1 year
Study: NCT04118894
Study Brief: Wright Foot & Ankle Post-Market Observational Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Foot and Ankle Devices The study subjects included are those treated with one or more approved or cleared Wright Medical products included in this study. 0 None 9 119 19 119 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
acute aortic dissection NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Below Knee Amputation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Infection NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Non-Union NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Algodystrophy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Blister Dorsal Aspect of Operated Foot NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Inflammatory Scar NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Wound Healing Complications NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Ulcer NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View