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 @ 3:55 PM
Ignite Modification Date: 2025-12-25 @ 2:00 PM
NCT ID: NCT01970592
Description: None
Frequency Threshold: 0
Time Frame: 5 years
Study: NCT01970592
Study Brief: Power Training Post-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
POWER Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking. POWER training: Individuals with chronic post-stroke hemiparesis will undergo training to improve muscle power generation for 24 sessions (3 times/week) that includes both resistive and task-specific elements. Session duration will be \~90 minutes/day (inclusive of rest intervals). Training will include five distinct resistance activities aimed at improving muscle power-- each previously reported to contribute to improved walking 0 None 1 56 3 56 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Medical DIagnosis NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Participant Fall NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View