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 @ 7:41 PM
Ignite Modification Date: 2025-12-25 @ 5:20 PM
NCT ID: NCT01235403
Description: None
Frequency Threshold: 5
Time Frame: During the study (up to 24 - 28 weeks). The study is comprised of a 12-week Titration Phase, a 12 -week Maintenance Phase, and a 3 to 4 week Taper Phase if needed.
Study: NCT01235403
Study Brief: Trial to Assess Optimized Dosage of Lacosamide as add-on Therapy in Patients With Partial Onset Seizure
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lacosamide Flexible dosing between 200mg/day and 400mg/day Lacosamide: 50 mg tablets bid. Titration phase: (12 weeks) 100 mg/day: duration 1 to 3 weeks. Then uptitration to optimal therapeutic dose of 200 mg/day to 400 mg/day, in steps of 100 mg/day and a time period per step of 1 to 3 weeks. Maintenance phase (12 weeks): Optimal therapeutic dose 200 mg/day to 400 mg/day. Taper phase if needed: 3 to 4 weeks None None 3 100 49 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 14.1 View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 14.1 View
Coma NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 14.1 View
Partial seizures with secondary generalisation NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Status epilepticus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 14.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (14.1) View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (14.1) View