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 @ 3:31 PM
Ignite Modification Date: 2025-12-25 @ 1:45 PM
NCT ID: NCT00535392
Description: None
Frequency Threshold: 5
Time Frame: Up to 4 days
Study: NCT00535392
Study Brief: Open-label Study of Levetiracetam Intravenous Infusion in Children (4-16 Years Old) With 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
Levetiracetam Intravenous 100 mg/mL, twice a day, maximum of 4 days Subjects on oral levetiracetam at study entry receive the same intravenous (IV) dosage (mg-for-mg) to their oral dose. Dosage for subjects not on levetiracetam at study entry was based on weight: if \<50 kg, the dose was 20 mg/kg/day (10 mg/kg/day twice daily); if weight ≥ 50 kg, the dose of levetiracetam intravenous (LEV IV) was 1000 mg/day (500 mg twice daily). None None 3 33 12 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
CONVULSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
NAUSEA NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
DRY MOUTH NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
VOMITING NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.0) View
PYREXIA NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.0) View
WEIGHT DECREASED NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA (9.0) View
CONVULSION NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
SOMNOLENCE NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.0) View
HYPOTENSION NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA (9.0) View