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 @ 1:19 AM
Ignite Modification Date: 2025-12-25 @ 11:27 PM
NCT ID: NCT02017093
Description: Adverse events for all the study participants, were monitored seperately for each of the participants, at the end of the last treatment session. At the end of the study no adveres events were reported from any of investigators to the ethics committee of the rehabilitation institute.
Frequency Threshold: 0
Time Frame: There were no adverse events during the whole trial.
Study: NCT02017093
Study Brief: Error Enhancement of the Velocity Component
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Error Enhancement Training of the upper extremity, using a robotic deviset with error enhanced forces and traditional therapy. Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included. None None 0 4 0 4 View
Control Group: Traditional Therapy Training of the upper extremity, using a robotic deviset without forces applied and traditional therapy. Error Enhancement deXtreme's prototype robot: The subjects were seated on comfortable chairs, individually adjusted, and connected to a manipulandum of deXtreme's prototype robot. We situated the chair so that the computer monitor could be clearly observed by the subject. Each subject's affected extremity was harnessed to a handle connected to a robotic arm accompanying the movement Optimal Velocity Profile and Calculation of Error Enhancement: Fugl-Meyer (FM) and the Motor Assessment Scale (MAS) tests were included. None None 0 3 0 3 View
Serious Events(If Any):
Other Events(If Any):