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 @ 2:21 AM
Ignite Modification Date: 2025-12-26 @ 12:52 AM
NCT ID: NCT02949934
Description: None
Frequency Threshold: 0
Time Frame: 8 days
Study: NCT02949934
Study Brief: Effects of Cortical Dopamine Regulation on Drinking, Craving, and Cognitive Control
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Placebo/rs4680 Val/Met Placebo three times per day for eight days Individuals with the rs4680 val/met genotype 0 None 0 17 0 17 View
Tolcapone/rs4680 Val/Met Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days Individuals with the rs4680 val/met genotype 0 None 0 16 1 16 View
Placebo/rs4680 Met/Met Placebo three times per day for eight days Individuals with the rs4680 met/met genotype 0 None 0 15 0 15 View
Tolcapone/rs4680 Met/Met Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days Individuals with the rs4680 met/met genotype 0 None 0 14 0 14 View
Placebo/rs4680 Val/Val Placebo three times per day for eight days Individuals with the rs4680 val/val genotype 0 None 0 16 1 16 View
Tolcapone/rs4680 Val/Val Tolcapone 100 mg three times per day for three days Tolcapone 200 mg three times per day for five days Individuals with the rs4680 val/val genotype 0 None 0 12 0 12 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pregnancy NON_SYSTEMATIC_ASSESSMENT Pregnancy, puerperium and perinatal conditions None View
Rash NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View