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 @ 3:51 PM
Ignite Modification Date: 2025-12-25 @ 1:57 PM
NCT ID: NCT02114892
Description: None
Frequency Threshold: 5
Time Frame: Adverse events were collected throughout the study
Study: NCT02114892
Study Brief: Effect of Resveratrol Administration on Metabolic Syndrome, Insulin Sensitivity and Insulin Secretion
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Resveratrol Resveratrol capsules, 500 mg, three times per day before meals during 90 days Resveratrol: Resveratrol capsules of 500 mg three times per day before meals with a total dosis of 1500 mg per day. None None 0 12 5 12 View
Placebo Calcined magnesia capsules, 500 mg, three times per day before meals during 90 days Placebo: Calcined magnesia capsules, 500 mg, three times per day before meals with a total dose per day of 1500 mg None None 0 12 4 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders ANY View
Abdominal pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ANY View
Sickness NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ANY View
Nosebleed NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders ANY View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ANY View
Flatulence NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders ANY View