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 @ 2:11 AM
Ignite Modification Date: 2025-12-26 @ 12:39 AM
NCT ID: NCT02892760
Description: 2 withdrew before adverse event data was collected.
Frequency Threshold: 0
Time Frame: 23 months
Study: NCT02892760
Study Brief: Clinical Algorithm for Post-Stroke Gait Training With C-Brace
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
With C-brace C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. C-Brace: C-Brace is a micro-computer controlled brace that is worn on the leg to assist with walking. 0 None 1 15 8 15 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Skin redness NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
High blood pressure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fall at home/office NON_SYSTEMATIC_ASSESSMENT General disorders None View
Skin pinch NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Blister NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Device non-function NON_SYSTEMATIC_ASSESSMENT Investigations None View