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 @ 11:25 PM
Ignite Modification Date: 2025-12-25 @ 9:10 PM
NCT ID: NCT01688856
Description: None
Frequency Threshold: 0
Time Frame: From enrollment to 6-month post-treatment outcome assessment.
Study: NCT01688856
Study Brief: Contralaterally Controlled FES of Arm & Hand for Subacute Stroke Rehabilitation
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Arm+Hand CCFES Uses an electrical stimulator that opens the paretic hand and extends the paretic elbow in response to and with an intensity proportional to movement of the contralateral arm and hand. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory. 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session. 0 None 0 28 4 28 View
Hand CCFES Uses an electrical stimulator that opens the paretic hand in response to and with an intensity proportional to movement of the contralateral hand. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided CCFES-mediated task practice performed 70 minutes twice a week in the research laboratory. 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 46 min/session. 0 None 0 28 7 28 View
Arm+Hand Cyclic NMES Uses an electrical stimulator that delivers stimulation to open the hand and extend the elbow repeatedly with preprogrammed timing and intensity. Electrical stimulator: The 12-week treatment period consists of two components: 1. Therapist-guided task practice performed 70 minutes twice a week in the research laboratory. (Stimulator not used during these sessions. To ensure that all 3 groups receive an equivalent dose of stimulation, this group has slightly lengthened self-administered hand opening exercise sessions at home.) 2. Self-administered hand opening exercise performed 10 sessions per week at home using the device. 60 min/session. 0 None 0 11 2 11 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Shoulder pain related to RW assessment NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Numbness and Tingling in Both Hands NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Abdominal Pain During RW Assessment NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Transient Discomfort from Stimulation NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View