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 @ 2:02 PM
Ignite Modification Date: 2025-12-25 @ 12:46 PM
NCT ID: NCT00416195
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00416195
Study Brief: Exploring the Safety And Tolerability of Doses of E2007 up to a Maximum of 12 mg In Patients With Refractory Partial Seizures
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Matching placebo once daily for 16 weeks (Days 1 to 112) None None 1 10 7 10 View
Perampanel 2 mg perampanel once daily for 2 weeks (Days 1 to 14), then 4 mg perampanel once daily for 2 weeks (Days 15 to 28), then 6 mg perampanel once daily for 2 weeks (Days 29 to 42), then 8 mg perampanel once daily for 2 weeks (Days 43 to 56), then 10 mg perampanel once daily for 2 weeks (Days 57 to 70), then 12 mg perampanel once daily for 6 weeks (the last 2 weeks of the Titration Phase \[Days 71 to 84\] and a 4-week Maintenance Phase \[Days 85 to 112\]) None None 1 38 15 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Colonic polyp SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V. 10.0 View
Convulsions SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V. 10.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhoea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA V. 10.0 View
Rhinitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA V. 10.0 View
Diabetes mellitus SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA V. 10.0 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V. 10.0 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V. 10.0 View
Muscle contractions involuntary SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V. 10.0 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA V. 10.0 View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA V. 10.0 View
Hypertension SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA V. 10.0 View