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 @ 2:52 AM
Ignite Modification Date: 2025-12-26 @ 1:33 AM
NCT ID: NCT02339233
Description: None
Frequency Threshold: 5
Time Frame: From implant through the end of the second intervention, an average of one year.
Study: NCT02339233
Study Brief: Epi Stim to Facilitate Standing and Stepping
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Epidural Stimulator Eligible participants will be implanted with 16-electrode epidural array in the T11-L1 area of the spinal cord Standing and Stepping with spinal cord Epidural Stimulation: Standing and Stepping with support from trainers as needed, overground or in a harness with body weight support on a treadmill. Epidural stimulation with specific configurations will be administered to generate standing and stepping. 0 None 2 8 5 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Device Malfunction NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Hip Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Muscle Strain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Flipped Stimulator NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Electrode Malfunction SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Incision Site Drainage NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Right Ankle Edema SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View