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 @ 12:24 AM
Ignite Modification Date: 2025-12-25 @ 10:29 PM
NCT ID: NCT02485158
Description: None
Frequency Threshold: 0
Time Frame: During study only (1 Day)
Study: NCT02485158
Study Brief: Individual Differences in the Response to Drugs
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Healthy Adult Volunteers 24 healthy adult volunteers completed a 6 session within-subject, double-blind, placebo-controlled trial. At three of these sessions, they received one of three recreational drugs, d-amphetamine, THC and alochol (only one drug was administered per drug session). The other three sessions were matched placebo sessions. At each session, they received a capsule and a drink. At the amphetamine drug session, they received a capsule containing d-amphetamine and a placebo beverage. At the THC drug session, they received a capsule containing THC and a placebo beverage. At the alcohol drug session they received a placebo capsule and a beverage containing alcohol. At the three matched placebo sessions, both the capsule and the beverage were placebo. None None 0 28 1 28 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
vomiting from alcohol dose NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View