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 @ 2:47 AM
Ignite Modification Date: 2025-12-26 @ 1:27 AM
NCT ID: NCT03233633
Description: The definitions of adverse event and serious adverse event do not differ from the definitions provided by clinicaltrials.gov. Adverse event data was collected by inpatient-care nursing staff members who continuously monitored each patient throughout their time enrolled in the study.
Frequency Threshold: 0
Time Frame: Adverse event data was collected from the entire duration for which each patient was enrolled in the study (minimum of 3 days).
Study: NCT03233633
Study Brief: Marijuana in Combination With Opioids in Palliative and Hospice Patients
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Medical Marijuana Treatment Arm Because this is a single-arm study, all 66 patients included in the study were in the treatment arm, and were administered medical marijuana. All 66 patients were in hospice care and were followed up until either 1) death or 2) unable to take the medication by mouth anymore. Therefore, the study was expected to have 100% all-cause mortality. 66 None 1 66 1 66 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Panic Attack NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Dizziness NON_SYSTEMATIC_ASSESSMENT General disorders None View