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 @ 3:29 PM
Ignite Modification Date: 2025-12-25 @ 1:44 PM
NCT ID: NCT00142792
Description: None
Frequency Threshold: 1
Time Frame: None
Study: NCT00142792
Study Brief: Functional Electrical Stimulation (FES) for Upper Extremity Recovery in Stroke
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
A. Cyclic Stim * Preprogrammed cycles of finger and thumb flexor and extensor stimulation (and flexor stimulation if deemed necessary by the PI) repeatedly and automatically close and open the hand without any effort or voluntary intent required by the subject. * Subject instructed to relax, not attempt to assist the stimulation, and not to move the contralateral arm/hand during stimulation NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. None None 10 39 1 39 View
C. EMG-Triggered EMG-Triggered electrical stimulation. Subjects in this group will attempt to extend their affected wrist and fingers in response to an audio cue. They will be "rewarded" with stimulation to cause full hand opening once they have generated EMG sufficient to reach a preset threshold level. NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. None None 13 41 3 41 View
B. Sensory Stim Sensory-only electrical stimulation. The stimulation will be cyclic in nature but intensity will be set to a level that can be felt by the patient but not sufficient to cause muscle contraction. NMES device with EMG-triggered and Cyclic capabilities: All groups will use the NeuroMove NM900 stimulator. Subjects will use the stimulator as described for their group (treatment arm) for two 40-minute sessions per day, 5 days per week for 8 weeks. Surface electrodes for all three groups will be placed over the affected EDC and ECR (finger and wrist extensor) muscles. None None 9 42 2 42 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Surgery or procedure NON_SYSTEMATIC_ASSESSMENT Investigations Adverse Events View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Adverse Event View
Other NON_SYSTEMATIC_ASSESSMENT General disorders Adverse Event View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders Adverse Events View
Illness, +/- hospitalization NON_SYSTEMATIC_ASSESSMENT General disorders Adverse Events View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shock NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications Adverse Events View
Muscle Twitch NON_SYSTEMATIC_ASSESSMENT Nervous system disorders Adverse Events View