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 @ 3:24 AM
Ignite Modification Date: 2025-12-26 @ 2:03 AM
NCT ID: NCT06235905
Description: Treatment Emergent Adverse Event (TEAE) is an adverse event (AE) with a start date on or after the first dose of study medication is taken, or that worsened following first administration of study medication.
Frequency Threshold: 5
Time Frame: Treatment Emergent Adverse Events (TEAEs) were collected after the first dose of study medication up to 12 days (i.e., safety follow up phone call 5 days after the last dose of study medication).
Study: NCT06235905
Study Brief: Open-Label of SPN-820 in Adults With Major Depressive Disorder
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
SPN-820 (2400 mg) SPN-820 (2400 mg) oral capsules Participants received SPN-820 6 x 400 mg capsules administered orally every 3 days for a 7-day treatment period. 0 None 0 40 25 40 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.1 View
Cognitive Disorder SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.1 View
Dry mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.1 View
Paraesthesia oral SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA version 26.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA version 26.1 View
Nasal congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA version 26.1 View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA version 26.1 View