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 @ 11:52 PM
Ignite Modification Date: 2025-12-25 @ 9:47 PM
NCT ID: NCT04690751
Description: None
Frequency Threshold: 0
Time Frame: 69 days
Study: NCT04690751
Study Brief: Bioavailability and Food Effect Study of Cenobamate as an Oral Suspension and Tablet
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment C Treatment C: Oral Dose of cenobamate administered at a single 200 mg/20 mL suspension under fed conditions 0 None 0 25 7 25 View
Treatment B Treatment B: Oral Dose of cenobamate administered as a single 200 mg/20 mL suspension under fasted conditions 0 None 0 24 8 24 View
Treatment A Treatment A: Oral Dose of cenobamate administered as a single 200 mg tablet under fasted conditions 0 None 0 25 8 25 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Catheter Site Related Reaction NON_SYSTEMATIC_ASSESSMENT General disorders None View
Covid-19 SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sunburn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Back Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Neck Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Presyncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Oropharyngeal Pain NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Nasal Congestion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dermatitis Contact NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Ecchymosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hyperhidrosis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pruitus SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Pseudofolliculitis SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Skin Lesion SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Paraesthesia Oral NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Euphoric Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Eczema SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Phlebitis SYSTEMATIC_ASSESSMENT Vascular disorders None View