Adverse Events Module

Home Icon Home Search Icon Search Certify Doc Icon Certify Doc Certify Doc Icon Genes Certify Doc Icon Clinical Trials Certify Doc Icon CompTox Processes Icon DrugMatrix Open Targets Icon Open Targets Processes Icon Products Support Icon Support Bugs Icon Bugs
Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug
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 @ 11:36 PM
Ignite Modification Date: 2025-12-25 @ 9:25 PM
NCT ID: NCT03247556
Description: Number of subjects is based on the Safety Population (defined as subjects who were randomized and took at least one dose of study medication)
Frequency Threshold: 5
Time Frame: 7 weeks
Study: NCT03247556
Study Brief: Evaluation of SPN-812 (Viloxazine Extended-release Capsule) High Dose in Adolescents With ADHD
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 Placebo oral capsule Treatment A: Placebo was administered once daily 0 None 0 97 40 97 View
400mg SPN-812 400mg SPN-812 oral capsule Treatment B: SPN-812 was administered once daily and compared to Placebo 0 None 2 100 92 100 View
600mg SPN-812 600mg SPN-812 oral capsule Treatment C: SPN-812 was administered once daily and compared to Placebo 0 None 0 99 74 99 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Suicide attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Syncope SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 20.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 20.1 View
Nasopharyngitis SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 20.1 View
Sedation SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 20.1 View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 20.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Abdominal Pain Upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View
Oropharyngeal pain SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 20.1 View