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 @ 9:07 PM
Ignite Modification Date: 2025-12-25 @ 6:58 PM
NCT ID: NCT01964404
Description: None
Frequency Threshold: 0
Time Frame: Since past assessment (1-2 weeks)
Study: NCT01964404
Study Brief: Cannabis, Schizophrenia and Reward: Self-Medication and Agonist Treatment?
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Marijuana cigarette and placebo capsule SCZ-CUD 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. Marijuana: Smoked plant with THC 0 None 1 11 9 11 View
Dronabinol and placebo cigarette SCZ-CUD Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI. Dronabinol: Capsule with THC 0 None 0 12 9 12 View
Placebo cigarette and placebo capsule. SCZ-CUD Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. Placebo: Capsule with no active ingredient 0 None 1 11 8 11 View
SCZ-CUD not randomized Dual diagnosis of Schizophrenia and Cannabis Use disorder, - Completed Scan 1 but not Randomized 0 None 1 8 2 8 View
Marijuana cigarette and placebo capsule CUD only CUD only 3-5% tetrahydrocannabinol cannabis cigarette smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. Marijuana: Smoked plant 0 None 0 17 14 17 View
Dronabinol and placebo cigarette CUD only CUD only Dronabinol 15mg 3-5% by mouth taken approximately 2.75 hours prior to the second functional MRI and a placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI. 0 None 0 17 10 17 View
Placebo cigarette and placebo capsule CUD only CUD only Placebo cigarette (for marijuana) smoked immediately prior to the second functional MRI and a placebo capsule (for dronabinol) by mouth taken approximately 2.75 hours prior to the second functional MRI. 0 None 0 17 14 17 View
Cannabis Use Disorder - CUD Did not randomize Cannabis Use Disorder (CUD), Completed Scan 1 but not Randomized 0 None 1 10 5 10 View
SCZ only No drug intervention - Completed Scan 1 and 2 0 None 2 18 13 18 View
SCZ only - Did not complete Scan 2 No drug intervention - Completed Scan 1 but not Scan 2 0 None 0 3 3 3 View
Healthy Control - No drug intervention - Completed Scan 1 and 2 0 None 0 27 14 27 View
Healthy Control - Did not complete Scan 2 No drug intervention - Completed Scan 1 but not Scan 2 0 None 0 4 0 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Vyvanse Intoxication SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Anxiety SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Hallucinations SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Increased cannabis withdrawal symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Psychiatric symptoms SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Tachycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Dental Issues SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Pain in extremity SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Anxiety in MRI SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Skin irritation SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Back, shoulder or neck pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders None View
MRI Finding - Nervous System SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Nausea or vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Upper Respiratory Infection SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Chalazia SYSTEMATIC_ASSESSMENT Eye disorders None View
Abnormal EKG SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Lightheaded/Dizzy SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dysesthesia/Parasthesia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Ear pain SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Hemorrhoids SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypotension SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Skin infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Muscle aches SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MRI Findings - Vascular SYSTEMATIC_ASSESSMENT Vascular disorders None View
MRI Findings - Respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Swelling of vein SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other SYSTEMATIC_ASSESSMENT Nervous system disorders None View