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 @ 5:09 PM
Ignite Modification Date: 2025-12-25 @ 2:47 PM
NCT ID: NCT03345550
Description: None
Frequency Threshold: 5
Time Frame: 3 months
Study: NCT03345550
Study Brief: OPTIMA-TBI Pilot Study
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 Polyunsaturated Fatty Acid Treatment Arm Participants randomized to this study arm received 6g DHA+EPA for one month followed by 1.2 g DHA+EPA for two months. Capsules contain fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules. Omega-3 Polyunsaturated Fatty Acids (Fish Oil 1000 mg (contains 500 mg DHA \& 100 mg EPA)) or placebo capsules.: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules. 0 None 0 22 3 22 View
Placebo Arm Participants randomized to this study arm received placebo drug for 3 months. Placebo - Cap: Participants were randomized to receive fish oil 1000 mg (contains 500 mg DHA \& 100 mg EPA) or placebo capsules (olive oil capsules that look identical to the intervention DHA+EPA). 0 None 0 22 0 22 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Diarrhea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCAE (5.0) View