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 @ 4:03 AM
Ignite Modification Date: 2025-12-26 @ 2:58 AM
NCT ID: NCT03406702
Description: Treatment-emergent adverse events (TEAEs) are all adverse events (AEs) occurring during the treatment period or a pretreatment event that worsens in intensity during the treatment period. The number of participants varied during Days 3-8 due to the lack of completion of assessments.
Frequency Threshold: 5
Time Frame: Adverse events (AEs) were collected from Day 1 up to Day 26 post-dose, or up to 1 year 3 weeks.
Study: NCT03406702
Study Brief: CX-8998 for Absence 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
CX-8998 Days 1 - 2 (4 mg/d) Participants were administered suvecaltamide orally 2mg capsules twice daily (4 mg/d) on Days 1 to 2. 0 None 0 7 2 7 View
CX-8998 Days 3 - 8 (8 mg/d) Participants were administered suvecaltamide orally 2-2mg capsules twice daily (8 mg/d) on Days 3 to 8. 0 None 0 5 2 5 View
CX-8998 Days 15 - 20 (16 mg/d) Participants were administered suvecaltamide orally 4-2mg capsules twice daily (16 mg/d) on Days 15 to 20. 0 None 0 6 1 6 View
CX-8998 Days 21 - 27 (20 mg/d) Participants were administered suvecaltamide orally 5-2mg capsules twice daily (20 mg/d) on Days 21 to 27. 0 None 0 6 2 6 View
CX-8998 Days 9 - 14 (12 mg/d) Participants were administered suvecaltamide orally 3-2mg capsules twice daily (12 mg/d) on Days 9 to 14. 0 None 0 6 0 6 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View
Sluggishness SYSTEMATIC_ASSESSMENT General disorders MedDRA (20.1) View
Seizure SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Lethargy SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA (20.1) View
Euphoric mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (20.1) View
Palpitations SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (20.1) View
Visual impairment SYSTEMATIC_ASSESSMENT Eye disorders MedDRA (20.1) View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (20.1) View