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 @ 9:43 PM
Ignite Modification Date: 2025-12-25 @ 7:24 PM
NCT ID: NCT04124432
Description: International Council for Harmonization (ICH) guidelines are followed for Adverse Event (AE) reporting, as AEs occur they are documented.
Frequency Threshold: 5
Time Frame: 0-5 hours
Study: NCT04124432
Study Brief: Behavioral Pharmacology of Cannabis and Nicotine
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 Cannabis Without Nicotine Smoked cannabis containing 10mg THC + No nicotine/tobacco Cannabis: Cannabis will be smoked 0 None 0 23 0 23 View
Active Cannabis With Own Brand Cigarettes Smoked cannabis containing 10mg THC + ad-libitum use of preferred brand cigarettes Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 20 0 20 View
Active Cannabis With Low Nicotine E-cigarette Smoked cannabis containing 10mg THC + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 24 1 24 View
Active Cannabis With High Nicotine E-cigarette Smoked cannabis containing 10mg THC + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 22 0 22 View
Placebo Cannabis With Own Brand Cigarettes Smoked placebo cannabis + ad-libitum use of preferred brand cigarettes Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 21 1 21 View
Placebo Cannabis With Low Nicotine E-cigarette Smoked placebo cannabis + ad-libitum use of low nicotine content E-Cig (3% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 22 0 22 View
Placebo Cannabis With High Nicotine E-cigarette Smoked placebo cannabis + ad-libitum use of high nicotine content E-Cig (5% nicotine JUUL) Cannabis: Cannabis will be smoked Nicotine: Nicotine will be smoked or vaporized 0 None 0 21 0 21 View
Serious Events(If Any):
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Vomitting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View