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 @ 7:04 PM
Ignite Modification Date: 2025-12-25 @ 4:38 PM
NCT ID: NCT02792257
Description: Serious adverse events were defined per FDA guidelines and reported in a timely manner.
Frequency Threshold: 0
Time Frame: Up to 3 weeks
Study: NCT02792257
Study Brief: Trial of Dronabinol Adjunctive Treatment of Agitation in Alzheimer's Disease
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Dronabinol Study medication will be administered twice daily. Capsules of dronabinol will contain 2.5 mg per dose (5mg daily) during Week 1, then increase to 5 mg per dose (10mg daily) for Weeks 2 and 3. Dronabinol (Marinol®): 5mg - 10mg daily dose 0 None 2 37 21 37 View
Placebo Placebo medication will be administered twice daily. Placebo: Daily dose 0 None 0 38 20 38 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Humeral Fracture NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Delirium NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fall NON_SYSTEMATIC_ASSESSMENT General disorders None View
Seizure NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Anemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Leukopenia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Urine Incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Edema NON_SYSTEMATIC_ASSESSMENT General disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Gait Disturbance NON_SYSTEMATIC_ASSESSMENT General disorders None View
Neuroleptic Malignant Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
COVID-19 NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Conjunctivitis NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Prostatitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
UTI NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Pressure Ulcer NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Skin Tear NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot Pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Required Pain Management NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Weakness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Appetite, Decreased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Appetite, Increased NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hyponatremia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Weight Loss NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Dysarthria NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Agitation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Confusion NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Paranoia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nosebleed NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Ingrown Toenail NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Hypotension NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View