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: 2025-12-25 @ 12:14 AM
Ignite Modification Date: 2025-12-25 @ 10:15 PM
NCT ID: NCT01345058
Description: All eligible participants. One participant in the Lacosamide + Low-Dose Levetiracetam arm did not receive study drug and is not included in the analysis. One participant never confirmed taking the study medication, never followed up, and was not included in the analysis.
Frequency Threshold: 5
Time Frame: 6 Months
Study: NCT01345058
Study Brief: Add on Lacosamide Versus High Dose Monotherapy
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Control Group (High-Dose Levetiracetam) Historical chart review of patients whose dose of levetiracetam was raised to high dose levetiracetam \>1500 mg/day (monotherapy) after a breakthrough seizure. No intervention was administered in the study. None None 0 36 26 36 View
Lacosamide + Low-Dose Levetiracetam Participants received lacosamide 50 mg twice a day for one week followed by 100 mg twice daily added to low dose levetiracetam ≤1500 mg/day (polytherapy) for 6 months in patients with breakthrough seizures on low-dose levetiracetam. None None 0 18 11 18 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Hair Loss SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Itching SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Irritability/depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue SYSTEMATIC_ASSESSMENT General disorders None View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Memory/cognitive difficulties/confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Decreased libido SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Erectile dysfunction SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders None View