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 @ 9:16 PM
Ignite Modification Date: 2025-12-25 @ 7:05 PM
NCT ID: NCT00361504
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT00361504
Study Brief: A Study to Evaluate Long-Term Safety of Multiple Doses of Tapentadol (CG5503) Prolonged-Release (PR) and Oxycodone Controlled-Release (CR) in Patients With Chronic Pain
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Tapentadol (CG5503) Tapentadol (CG5503) extended release (ER) 100 to 250mg twice daily (BID) for up to one year None None 49 894 766 894 View
Oxycodone Oxycodone controlled release (CR) 20 to 50mg twice daily (BID) for up to one year. None None 9 223 202 223 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Angina Pectoris NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Cardiac Failure Congestive NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Coronary Artery Disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Myocardial Infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Ventricular Fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Abdominal Pain NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colonic Polyp NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diabetic Gastroparesis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Impaired Gastric Emptying NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Volvulus NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Colitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ileitis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Small Intestinal Obstruction NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ankle Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Femoral Neck Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Fibula Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Foot Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hip Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Lower Limb Fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Subdural Haematoma NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Thermal Burn NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Ligament Sprain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Appendicitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Diverticulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pyelonephritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Shock NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Urinary Tract Infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Asthenia NON_SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain NON_SYSTEMATIC_ASSESSMENT General disorders None View
Drug Withdrawal Syndrome NON_SYSTEMATIC_ASSESSMENT General disorders None View
Hernia Obstructive NON_SYSTEMATIC_ASSESSMENT General disorders None View
Oedema Peripheral NON_SYSTEMATIC_ASSESSMENT General disorders None View
Treatment Failure NON_SYSTEMATIC_ASSESSMENT General disorders None View
Syncope NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nerve Compression NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Bipolar Disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Euphoric Mood NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Substance Abuse NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Suicidal Ideation NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Joint Swelling NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Pain in Extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Lumbar Spinal Stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Chronic Obstructive Pulmonary Disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Acute Respiratory Distress Syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Asthma NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dysphonia NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Dehydration NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Anorexia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypoglycemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Hypokalemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Breast cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Thymoma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Thyoid Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Benign Gastrointestinal Neoplasm NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hydrocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders None View
Vertigo NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders None View
Visual Disturbance NON_SYSTEMATIC_ASSESSMENT Eye disorders None View
Cholecystitis NON_SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
Breast Mass NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Menstrual Disorder NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
Erythema NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Deep Vein Thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pruritus NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Dry Mouth NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Diarrhoea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Somnolence NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Dizziness NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Nasopharyngitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Sinusitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations None View
Insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Fatigue NON_SYSTEMATIC_ASSESSMENT General disorders None View
Constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View