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 @ 9:22 PM
Ignite Modification Date: 2025-12-25 @ 7:09 PM
NCT ID: NCT04650204
Description: None
Frequency Threshold: 0
Time Frame: Adverse events were collected from a baseline to end of study participation for approximately 12 months on all participants.
Study: NCT04650204
Study Brief: Perampanel for the Reduction of Seizure Frequency in Patients With High-grade Glioma and Focal Epilepsy
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 B (ASD) Patients receive ASD per standard of care for 40 weeks in the absence of disease progression or unacceptable toxicity. Anticonvulsant Agent: Given ASD Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies 0 None 0 1 0 1 View
Arm A (Perampanel) Patients receive perampanel PO QD for 40 weeks in the absence of disease progression or unacceptable toxicity. Perampanel: Given PO Quality-of-Life Assessment: Ancillary studies Questionnaire Administration: Ancillary studies 0 None 0 3 2 3 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Imbalance & problems with coordination SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Valproic acid Toxicity SYSTEMATIC_ASSESSMENT General disorders None View
Headaches SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fever SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View