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 @ 5:04 PM
Ignite Modification Date: 2025-12-25 @ 2:44 PM
NCT ID: NCT00498550
Description: None
Frequency Threshold: 5
Time Frame: 12 Weeks
Study: NCT00498550
Study Brief: Treatment of Schizophrenia and Comorbid Cannabis Use Disorder: Comparing Clozapine to Treatment-as-Usual
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Clozapine Clozapine, Clozaril None None 4 15 15 15 View
Treatment as Usual Treatment as usual with any antipsychotic other than Clozapine. None None 4 16 15 16 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Psychiatric Disorder - Other: Accidental Overdose SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCEA View
Suicide Attempt SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Psychosis SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Pancreatitis SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Agitation SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Akathisia SYSTEMATIC_ASSESSMENT Nervous system disorders CTCEA View
Constipation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Dizziness SYSTEMATIC_ASSESSMENT Nervous system disorders CTCEA View
Dry Mouth SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Fatigue SYSTEMATIC_ASSESSMENT General disorders CTCEA View
Flu Like Symptoms SYSTEMATIC_ASSESSMENT General disorders CTCEA View
Gastrointestinal Disorder - Other: Hypersalivation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Headache SYSTEMATIC_ASSESSMENT Nervous system disorders CTCEA View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders CTCEA View
Insomnia SYSTEMATIC_ASSESSMENT Psychiatric disorders CTCEA View
Irritability SYSTEMATIC_ASSESSMENT General disorders CTCEA View
Libido Decreased SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders CTCEA View
Musculoskeletal And Connective Tissue Disorder - Other: Muscle Spasms SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders CTCEA View
Nasal Congestion SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders CTCEA View
Nausea SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Nervous Sytem Disorder - Other: Unusual Dream Activity SYSTEMATIC_ASSESSMENT Nervous system disorders CTCEA View
Non-Cardiac Chest Pain SYSTEMATIC_ASSESSMENT General disorders CTCEA View
Somnolence SYSTEMATIC_ASSESSMENT Nervous system disorders CTCEA View
Urinary Incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders CTCEA View
Vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders CTCEA View
Weight Gain SYSTEMATIC_ASSESSMENT Investigations CTCEA View