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 @ 5:19 PM
Ignite Modification Date: 2025-12-25 @ 2:55 PM
NCT ID: NCT02132650
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were monitored over a period of approximately 6 months, from enrollment in the study until completion of the 3-month follow up assessment.
Study: NCT02132650
Study Brief: Rehabilitating Corticospinal Control of Walking
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Accurate Walking Training Rehabilitation of walking using accurate (ACC) walking tasks ACC training: Rehabilitation of walking using accurate (ACC) walking tasks, such as stepping on targets, over obstacles, etc. 0 None 1 20 5 20 View
Steady State Walking Training Rehabilitation of walking using typical steady state (SS) walking SS training: Rehabilitation of walking using typical steady state (SS) walking. Conducted overground and on treadmill. 36 sessions of training conducted over the course of 12 weeks. Each session lasts about 1 hour. 0 None 1 18 6 18 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
unstable medical condition NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bone fracture occurring offsite NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
falling NON_SYSTEMATIC_ASSESSMENT General disorders None View
seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
car accident NON_SYSTEMATIC_ASSESSMENT General disorders None View