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 @ 11:03 PM
Ignite Modification Date: 2025-12-25 @ 8:34 PM
NCT ID: NCT03995069
Description: None
Frequency Threshold: 0
Time Frame: During the study participation (approximately 10 weeks)
Study: NCT03995069
Study Brief: Novel Training Environment to Normalize Altered Finger Force Direction 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
Visual Feedback of 3D Digit Force The participant's voluntary grip forces in all 3 dimensions will be shown to the participant via computer screen. 3D: Practice generating grip force to the target shown on the computer screen in 3 dimensions. 0 None 2 22 18 22 View
Visual Feedback of 1D Digit Force The participant's voluntary grip force in 1 dimension will be shown to the participant via computer screen. 1D: Practice generating grip force to the target shown on the computer screen in 1 dimension. 0 None 3 23 18 23 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
drug abuse NON_SYSTEMATIC_ASSESSMENT General disorders None View
tremor with new seizure medication NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
car accident NON_SYSTEMATIC_ASSESSMENT General disorders None View
transient amnesia, blackout NON_SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
other adverse events SYSTEMATIC_ASSESSMENT General disorders None View