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 @ 5:12 AM
Ignite Modification Date: 2025-12-26 @ 4:17 AM
NCT ID: NCT02633527
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: 8 Weeks
Study: NCT02633527
Study Brief: Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children 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 Treatment A: Placebo was administered once daily 0 None 0 24 3 24 View
100mg SPN-812 Treatment B: 100mg SPN-812 was administered once daily and compared to placebo 0 None 0 48 23 48 View
200mg SPN-812 Treatment C: 200mg SPN-812 was administered once daily and compared to placebo 0 None 0 48 22 48 View
300mg SPN-812 Treatment D: 300mg SPN-812 was administered once daily and compared to placebo 0 None 0 48 30 48 View
400mg SPN-812 Treatment E: 400mg SPN-812 was administered once daily and compared to placebo 0 None 0 49 30 49 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Fatigue SYSTEMATIC_ASSESSMENT General disorders MedDRA 18.1 View
Gastroenteritis viral SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 18.1 View
Weight decreased SYSTEMATIC_ASSESSMENT Investigations MedDRA 18.1 View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 18.1 View
Irritability SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 18.1 View
Abdominal pain upper SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View
Decreased appetite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 18.1 View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 18.1 View