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 @ 5:58 PM
Ignite Modification Date: 2025-12-25 @ 3:21 PM
NCT ID: NCT03123068
Description: None
Frequency Threshold: 5
Time Frame: 8 weeks
Study: NCT03123068
Study Brief: Cocoa Flavanols for Modulating Immune Response and Accelerating Recovery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Active Treatment Group - Group A Participants will receive a daily oral dose of 1,000 mg cocoa flavanol (CocoaVia®) for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day. CocoaVia®: CocoaVia® is manufactured by Mars, Inc. It is a dietary supplement of cocoa bean extract, containing 125 mg cocoa flavanols per capsule. 0 None 1 22 8 22 View
Placebo Treatment Group - Group B Participants will receive a daily oral dose of a placebo for 5 days before surgery. The daily dose will consist of 8 capsules in divided doses throughout the day. Placebo: The placebo capsules will contain an inert ingredient packaged to be indistinguishable from the active treatment. 0 None 0 20 7 20 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Pain SYSTEMATIC_ASSESSMENT General disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
bursitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
elevated BP SYSTEMATIC_ASSESSMENT Vascular disorders None View
dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders None View
bladder pain SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
blisters at wound site SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
labile BP SYSTEMATIC_ASSESSMENT Vascular disorders None View
loss of appitite SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
lower extremity swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pain SYSTEMATIC_ASSESSMENT General disorders None View
tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
urinary frequency SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View