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 @ 10:48 PM
Ignite Modification Date: 2025-12-25 @ 8:18 PM
NCT ID: NCT00368069
Description: Adverse Event reporting is data is taken from the Safety Set (SS) analysis group. The SS is comprised all subjects who were dispensed study medication.
Frequency Threshold: 5
Time Frame: Adverse Events were collected from Selection Visit (Week 0) until Final Visit (Week 22).
Study: NCT00368069
Study Brief: A Study to Look at the Efficacy and Safety of Keppra® Extended Release Formulation - XR
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Keppra® Keppra® extended release formulation (XR) None None 6 77 23 77 View
Placebo placebo None None 2 79 21 79 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Concussion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 9.0 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Ischaemic stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Partial seizures with secondary generalisation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Simple partial seizures NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Stupor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Respiratory failure NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 9.0 View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue 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
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 9.0 View
Influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 9.0 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 9.0 View