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 @ 5:02 AM
Ignite Modification Date: 2025-12-26 @ 4:03 AM
NCT ID: NCT00467818
Description: None
Frequency Threshold: 5
Time Frame: The adverse event data were collected over the course of the study from the start in 2007 until completion in 2011. Each participant was observed for adverse events during the course of their treatment which was the course of the study, ie 12 weeks. Participants were not monitored for adverse events after the completion of the study.
Study: NCT00467818
Study Brief: Omega 3 Fatty Acids in the Treatment of Children With Autism Spectrum Disorders
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Omega 3 Fatty Acids, Drug Omega 3 Fatty acids will be dispensed to subjects in the active experimental group of the study. Omega 3 fatty acids : The study will start with low doses and based on the weight of the individual the dosage will be increased biweekly. None None 0 9 0 9 View
Placebo The placebo will be dispensed to subjects in the control group Placebo : Same dosage as that of omega 3 fatty acids None None 1 8 0 8 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Recurrence of mood disorder in one participant NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):