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: 2025-12-25 @ 12:56 AM
Ignite Modification Date: 2025-12-25 @ 11:11 PM
NCT ID: NCT05511467
Description: Adverse events were defined as unexpected events during experimental procedures, specifically including magnetic resonance imaging (MRI), related or unrelated to experimental procedures.
Frequency Threshold: 1
Time Frame: Adverse event data was collected for the duration of the experimental procedures (approximately 4 individual visits within 2 consecutive weeks).
Study: NCT05511467
Study Brief: Learning 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
stroke group Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'. 0 None 0 25 0 25 View
control group Visuomotor learning task: Participants undergo functional magnetic resonance imaging during the performance of the visuomotor learning task. The visuomotor learning task involves holding a device in the hand that measures the strength of the grip when squeezing the 'gripper'. 0 None 0 15 1 15 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Incidental finding during MRI SYSTEMATIC_ASSESSMENT Nervous system disorders None View