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 @ 4:15 PM
Ignite Modification Date: 2025-12-25 @ 2:13 PM
NCT ID: NCT02582866
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected from Visit 1 (Week 0) to Final Visit (up to Week 158)
Study: NCT02582866
Study Brief: A Clinical Study to Investigate the Long-term Use of Lacosamide as Monotherapy in Subjects Who Completed Study SP0994
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 (SS) Lacosamide (LCM) was administered orally, twice daily from 200 mg/day to 600 mg/day, in 2 divided doses at approximately 12 hour intervals in the morning and in the evening. The investigator may have maintained the subject's LCM dose, decreased the dose in decrements of 100 mg/day per week to a minimum dose of LCM 200 mg/day, or increased the dose in increments of 100 mg/day per week up to a maximum dose of LCM 600 mg/day. Participants stopping LCM should have been tapered off LCM at recommended decreasing steps of 200 mg/day/week. A slower taper (eg, 100 mg/day/week) or faster taper was permitted but the duration of tapering should not have exceeded 6 weeks. Participants formed the Safety Set (SS). 1 None 15 106 19 106 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Hypoglycaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA16.1 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA16.1 View
Breast Cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA16.1 View
Peripheral Sensorimotor Neuropathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA16.1 View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA16.1 View
Atrial Flutter NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA16.1 View
Cardiac Failure NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA16.1 View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA16.1 View
Ventricular Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA16.1 View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA16.1 View
Gastrooesophageal Reflux Disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA16.1 View
Umbilical Hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA16.1 View
Device Dislocation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA16.1 View
Sudden Unexplained Death In Epilepsy NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA16.1 View
Forearm Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA16.1 View
Post Gastric Surgery Syndrome NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA16.1 View
Tibia Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA16.1 View
Arteriogram Coronary NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA16.1 View
Epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA16.1 View
Ischaemic Stroke NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA16.1 View
Dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA16.1 View
Knee Arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA16.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA16.1 View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA16.1 View