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 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:11 AM
NCT ID: NCT02996305
Description: None
Frequency Threshold: 5
Time Frame: 12 Weeks
Study: NCT02996305
Study Brief: A Study in Adults and Adolescents With Angelman Syndrome (STARS)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
OV101 BID OV101 15 mg Evening OV101 10 mg Morning 0 None 1 29 19 29 View
Placebo Placebo Morning and Evening 0 None 0 29 13 29 View
OV101 QD OV101 15mg Evening 0 None 1 29 18 29 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
General disorders and administration site conditions NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Decreased appetite NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Lethargy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Aggression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Myoclonic epilepsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Myoclonus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Irritability NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View