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 @ 3:46 AM
Ignite Modification Date: 2025-12-26 @ 2:33 AM
NCT ID: NCT00915902
Description: Adverse Events were only collected and reported during the clinical trial, not after the conclusion of the trial, or prior to its start.
Frequency Threshold: 5
Time Frame: During the 20 week duration of the clinical trial. Specifically, during the first 8 week treatment period, the subsequent 4 week washout period, and the following 8 week treatment period.
Study: NCT00915902
Study Brief: Fish Oil Study for High Triglyceride Levels in Children
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Treatment (Lovaza) Followed by Placebo, During Treatment Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of treatment before placebo. None None 0 20 0 20 View
Treatment (Lovaza) Followed by Placebo, During Placebo Omega-3-acid ethyl esters (Lovaza) two 1-gram capsules taken twice daily for 8 weeks followed by placebo for 8 weeks. Adverse events during 8 weeks of placebo, after 8 weeks of treatment and 4 weeks of washout. None None 0 20 0 20 View
Placebo Followed by Treatment (Lovaza), During Placebo Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week placebo, after 8 weeks of treatment with Lovaza and a 4 week washout. None None 0 22 0 22 View
Placebo Followed by Treatment (Lovaza), During Treatment Placebo, two 1-gram capsules (corn oil) taken twice daily for 8 weeks followed by 4 week washout then treatment (Lovaza) for 8 weeks. Adverse events during 8 week Treatment with Lovaza that followed 8 weeks of placebo and a 4 week washout. None None 1 22 0 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
depression, worsening SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):