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 @ 3:25 AM
Ignite Modification Date: 2025-12-26 @ 2:05 AM
NCT ID: NCT00044005
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00044005
Study Brief: Safety and Tolerability Study of Drug to Treat 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 20 mg Lurasdione 20 mg oral tablets None None 3 32 19 32 View
Lurasidone 40 mg Lurasidone 40 mg oral tablets None None 6 33 22 33 View
Lurasidone 80mg Lurasidone 80mg oral tablets None None 3 33 18 33 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Sinus tachycardia None Cardiac disorders None View
Fall None Injury, poisoning and procedural complications None View
Lower Limb Fracture None Injury, poisoning and procedural complications None View
Pelvic Fracture None Injury, poisoning and procedural complications None View
Hypokalaemia None Metabolism and nutrition disorders None View
Schizophrenia None Psychiatric disorders None View
Suicidal Behavior None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Endotracheal Intubation None Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Constipation None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Seasonal Allergy None Immune system disorders None View
Influenza None Infections and infestations None View
Upper Respiratory Tract Infection None Infections and infestations None View
Urinary Tract Infection None Infections and infestations None View
Fall None Injury, poisoning and procedural complications None View
Skin Laceration None Injury, poisoning and procedural complications None View
Blood Creatine Phosphokinase Increased None Investigations None View
Blood Pressure Increased None Investigations None View
Weight Decreased None Investigations None View
Weight Increased None Investigations None View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal Stiffness None Musculoskeletal and connective tissue disorders None View
Pain in Extremity None Musculoskeletal and connective tissue disorders None View
Akathisia None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Dyskinesia None Nervous system disorders None View
Somnolence None Nervous system disorders None View
Insomnia None Psychiatric disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Oropharyngeal Pain None Respiratory, thoracic and mediastinal disorders None View
Ear Pain None Ear and labyrinth disorders None View
Eye Pain None Eye disorders None View
Dry Mouth None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Salivary Hypersecretion None Gastrointestinal disorders None View
Toothache None Gastrointestinal disorders None View
Fatigue None General disorders None View
Oedema Peripheral None General disorders None View
Nasopharyngitis None Infections and infestations None View
Headache None Nervous system disorders None View
Sedation None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Depressed Mood None Psychiatric disorders None View
Suicidal Ideation None Psychiatric disorders None View
Depression None Psychiatric disorders None View