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 @ 11:58 PM
Ignite Modification Date: 2025-12-25 @ 9:55 PM
NCT ID: NCT00610558
Description: All-Cause Mortality, Serious, and non-serious Adverse Events were monitored/assessed, but none observed
Frequency Threshold: 0
Time Frame: Subjects monitored for safety events during the entire imaging session; up to 1 hour
Study: NCT00610558
Study Brief: Neocortical Epilepsies - Do They Progress?
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 1: Juvenile Myoclonic Epilepsy 15 Subjects were monitored/assessed, but none observed 0 None 0 15 0 15 View
Arm 2: Frontal Lobe Epilepsy 14 Subjects were monitored/assessed, but none observed 0 None 0 14 0 14 View
Arm 3: Normal Controls 14 Subjects were monitored/assessed, but none observed 0 None 0 14 0 14 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Allergic reactions to the contrasts SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bleeding, soreness or swelling of injection site SYSTEMATIC_ASSESSMENT General disorders None View