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 @ 11:50 PM
Ignite Modification Date: 2025-12-25 @ 9:45 PM
NCT ID: NCT00655551
Description: None
Frequency Threshold: 5
Time Frame: up to 7 days
Study: NCT00655551
Study Brief: Safety of Intravenous Lacosamide Dose Followed by Twice Daily Oral Lacosamide in Subjects With Partial-onset Seizures
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 (400 mg) Single loading dose of intravenous (iv) lacosamide 400 mg followed by 6.5 days of oral lacosamide 200 mg twice daily None None 1 25 20 25 View
Lacosamide (200 mg) Single loading dose of intravenous (iv) lacosamide 200 mg followed by 6.5 days of oral lacosamide 100 mg twice daily None None 0 25 7 25 View
Lacosamide (300 mg) Single loading dose of intravenous (iv) lacosamide 300 mg dose followed by 6.5 days of oral lacosamide 150 mg twice daily None None 0 50 37 50 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diplopia NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (9.1) View
Vision blurred NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (9.1) View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Dry mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Hypoaesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Paraesthesia oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Gait disturbance NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Tremor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.1) View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA (9.1) View
Coordination abnormal NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (9.1) View
Hyperhidrosis NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (9.1) View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (9.1) View