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 @ 4:00 PM
Ignite Modification Date: 2025-12-25 @ 2:02 PM
NCT ID: NCT02058966
Description: None
Frequency Threshold: 0
Time Frame: None
Study: NCT02058966
Study Brief: Pilot Study of Entacapone for Methamphetamine Abuse
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Open-label Methamphetamine Subject will receive one dose of open-label methamphetamine 20 mg oral dose on their second visit, the familiarization visit. 0 None 0 19 1 19 View
Placebo-Meth Subjects will receive placebo, then one hour later, methamphetamine Placebo: capsules compounded to be of similar appearance to the active drugs Methamphetamine: Methamphetamine 20 mg oral dose 0 None 0 13 0 13 View
Entacapone-Placebo Subjects will receive entacapone, then one hour later, placebo Placebo: capsules compounded to be of similar appearance to the active drugs Entacapone: Entacapone 200 mg oral dose 0 None 0 12 0 12 View
Placebo-Placebo Subjects will receive placebo, then one hour later, placebo Placebo: capsules compounded to be of similar appearance to the active drugs 0 None 0 13 0 13 View
Entacapone-Meth Subjects will receive entacapone, then one hour later, methamphetamine Methamphetamine: Methamphetamine 20 mg oral dose Entacapone: Entacapone 200 mg oral dose 0 None 0 13 0 13 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View