Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 2:55 AM
Ignite Modification Date: 2025-12-26 @ 1:36 AM
NCT ID: NCT01463033
Description: The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group.
Frequency Threshold: 0
Time Frame: 30 day treatment period
Study: NCT01463033
Study Brief: Levetiracetam to Prevent Post-Traumatic 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 The 66 subjects with acute head injury with a high risk for developing post-traumatic epilepsy that received levetiracetam 55 mg/kg/day in a b.i.d. were monitored for adverse events through the 30 day treatment period. Adverse events were not monitored for the Observational group. None None 18 66 66 66 View
Observational Adverse events were not monitored for the Observational group None None 0 0 0 0 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Halluscinations NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Suicidality NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Psychosis NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE (4.0) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Drowsiness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Memory Impairment NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Pain NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders CTCAE View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders CTCAE View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCAE View
Cognitive disturbance NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders CTCAE View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders CTCAE View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE View
Cough NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCAE View
Weight Gain NON_SYSTEMATIC_ASSESSMENT Investigations CTCAE View