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 @ 1:05 AM
Ignite Modification Date: 2025-12-25 @ 11:18 PM
NCT ID: NCT04050293
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: Baseline (Day 1) to Week 26
Study: NCT04050293
Study Brief: Therapy for Migraine Prevention in Children 6-11 Years of Age
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo Participants received Placebo once a day. 0 None 0 12 2 12 View
SPN-538 Participants received SPN-538 once a day starting at 25 mg/day and increasing every 2 weeks in 25-mg increments to a target dose of 2 to 3 mg/kg/day or the maximal tolerated dose (MTD), whichever is less. 0 None 0 14 6 14 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Ammonia increased SYSTEMATIC_ASSESSMENT Investigations MedDRA (24.1) View
Rash SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA (24.1) View
Arthropod sting SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.1) View
Skin Laceration SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.1) View
Asthma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.1) View
Cough SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.1) View
Rhinorrhoea SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA (24.1) View
Dyspepsia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA (24.1) View
COVID-19 SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.1) View
Croup infectious SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (24.1) View
Depressed mood SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.1) View
Mood altered SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (24.1) View
Hypersensitivity SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (24.1) View
Rhinitis allergic SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA (24.1) View
Skin abrasion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA (24.1) View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA (24.1) View