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 @ 2:22 AM
Ignite Modification Date: 2025-12-26 @ 12:54 AM
NCT ID: NCT00088634
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00088634
Study Brief: A Study to Test the Effectiveness and Safety of a New Medication in the Treatment of Schizophrenia
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lurasidone 80 mg 2 40 mg lurasidone tablets taken once/day None None 2 90 53 90 View
Placebo Matching placebo to lurasidone 40 mg tablets taken once/day None None 3 90 37 90 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Blood Creatine Phosphokinase Increased None Investigations None View
Schizophrenia NOS None Psychiatric disorders None View
Chronic Obstructive Airways Disease None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Upper Respiratory Tract Infection None Infections and infestations None View
Back Pain None Musculoskeletal and connective tissue disorders None View
Akathisia None Nervous system disorders None View
Headache None Nervous system disorders None View
Sedation None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Anxiety None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View