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: 2025-12-24 @ 6:55 PM
Ignite Modification Date: 2025-12-25 @ 4:28 PM
NCT ID: NCT04106557
Description: None
Frequency Threshold: 0
Time Frame: 12 Weeks
Study: NCT04106557
Study Brief: A Study of OV101 in Individuals With Angelman Syndrome (AS)
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 Once Daily (Weight-based Dosing) Other Name:Gaboxadol OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration Gaboxadol: OV101 versus placebo once daily at bedtime for 12 weeks Age (Actual) 4 to 12 Years at Screening 0 None 1 47 31 47 View
Placebo Once Daily Matching placebo,oral, provided once daily at bedtime for 12 week duration Placebo: Matching placebo capsules to OV101 capsules. 0 None 0 50 22 50 View
OV101 Once Daily (Weight-based Dosing) Age 2-3 OV101 (gaboxadol), oral, provided once daily at bedtime for 12 week duration Age (Actual) 2 to 3 Years at Screening 0 None 0 7 4 7 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Drooling NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22 View
Pyrexia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22 View
URI NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22 View
Ear Infection NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA Version 22 View
Insomnia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22 View
Lethargy NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA Version 22 View
Prolonged aPTT NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA Version 22 View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA Version 22 View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22 View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22 View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22 View
Generalized tonic-clonic seizure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22 View
Irritability NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22 View
Somnolence NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA Version 22 View
Contusion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA Version 22 View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA Version 22 View