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 @ 6:25 PM
Ignite Modification Date: 2025-12-25 @ 3:55 PM
NCT ID: NCT03224468
Description: Adverse events are reported for baseline-3 months, as the primary outcomes were assessed at 3 months.
Frequency Threshold: 5
Time Frame: Adverse event data was collected for 3 months.
Study: NCT03224468
Study Brief: Effect of Medical Marijuana on Neurocognition and Escalation of Use
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 Arm This group can begin using medical marijuana immediately. Medical Marijuana: Patients in this group can choose when, where, and how much medical marijuana to use. 0 None 1 105 90 105 View
Waitlist Control Arm This group agrees to wait 3 months before using medical marijuana. 0 None 0 81 60 81 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cardiac Ablation SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA (Unspecified) View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Immune system disorders SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA View
Infections and infestations SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA (Unspecified) View
Psychiatric symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA (Unspecified) View
General disorders and conditions SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Nervous system symptoms SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Injury and poisoning SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Gastrointestinal disorders SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Respiratory, thoracic, and mediastinal disorders SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Musculoskeletal disorders SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View