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: 2025-12-26 @ 11:12 PM
Ignite Modification Date: 2025-12-26 @ 11:12 PM
NCT ID: NCT01029912
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01029912
Study Brief: Electrical Stimulation for Recovery of Ankle Dorsiflexion in Chronic Stroke Survivors
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
CCNMES Contralaterally Controlled Neuromuscular Electrical Stimulation (Electrical Stimulator) Electrical stimulator: 6-week intervention 15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week. Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device. None None 0 12 1 12 View
Cyclic NMES Cyclic Neuromuscular Electrical Stimulation (Electrical Stimulator) Electrical stimulator: 6-week intervention 15 minutes of therapist-guided stimulated ankle exercise + 30 minutes of physical therapy in the laboratory twice a week. Self-administered active repetitive ankle dorsiflexion exercise performed twice a day, 6 days a week at home using the device. None None 0 12 1 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Discomfort from stimulation SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View