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 @ 9:42 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT04312932
Description: Safety Monitoring Uniform Report Form (SMURF)
Frequency Threshold: 0
Time Frame: 90 days
Study: NCT04312932
Study Brief: Fatty Acid Supplementation in Children With ASD (Study 2)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
GLA + EPA + DHA Group 50 mg/kg of gamma-linoleic acid (GLA) + eicosapentaenoic acid (EPA) + docosahexaenoic acid (DHA) as Omega 3-6 oil to be administered twice per day by mouth for 90 days LCPUFA Oil Supplement: 50 mg/kg of GLA+EPA+DHA as Omega 3-6 oil to be administered twice per day by mouth for 90 days 0 None 0 48 45 48 View
Canola Oil Group Assignment an equivalent volume of canola oil as the GLA+EPA+DHA group, based on body weight. 0 None 0 48 46 48 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Energy level SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Gastrointestinal and eating SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Musculoskeletal and movement SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Skin or hair SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest or breathing SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ears SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Eyes SYSTEMATIC_ASSESSMENT Eye disorders None View
Genitourinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Heart SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Mouth lips teeth SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Nose, sinus, throat SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Psychological SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Sleep SYSTEMATIC_ASSESSMENT Psychiatric disorders None View