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: 2025-12-26 @ 11:13 PM
Ignite Modification Date: 2025-12-26 @ 11:13 PM
NCT ID: NCT01123512
Description: None
Frequency Threshold: 2
Time Frame: None
Study: NCT01123512
Study Brief: The Kiva® System as a Vertebral Augmentation Treatment
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Kiva VCF Treatment System Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures None None 44 153 81 153 View
Balloon Kyphoplasty Vertebral augmentation: Vertebral augmentation for one or two osteoporotic vertebral compression fractures None None 51 147 80 147 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cytomegalovirus colitis None Infections and infestations None View
Infection None Infections and infestations None View
Influenza None Infections and infestations None View
Intervertebral discitis None Infections and infestations None View
Peridiverticulitis None Infections and infestations None View
Pneumonia None Infections and infestations None View
Post procedural infection None Infections and infestations None View
Pseudomembranous colitis None Infections and infestations None View
Respiratory tract infection None Infections and infestations None View
Sepsis None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Airway complication of anesthesia None Injury, poisoning and procedural complications None View
Cervical vertebral fracture None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Femoral neck fracture None Injury, poisoning and procedural complications None View
Femur fracture None Injury, poisoning and procedural complications None View
Fracture None Injury, poisoning and procedural complications None View
Hip fracture None Injury, poisoning and procedural complications None View
Muscle injury None Injury, poisoning and procedural complications None View
Pelvic fracture None Injury, poisoning and procedural complications None View
Rib fracture None Injury, poisoning and procedural complications None View
Spinal compression fracture None Injury, poisoning and procedural complications None View
Wrist fracture None Injury, poisoning and procedural complications None View
Dehydration None Metabolism and nutrition disorders None View
Electrolyte imbalance None Metabolism and nutrition disorders None View
Failure to thrive None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Intervertebral disc disorder None Musculoskeletal and connective tissue disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Soft tissue necrosis None Musculoskeletal and connective tissue disorders None View
Spinal column stenosis None Musculoskeletal and connective tissue disorders None View
Spondylolysis None Musculoskeletal and connective tissue disorders None View
Breast cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Lung cancer metas None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Multiple myeloma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Myelodysplastics None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Plasmacytoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Spinal menigioma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Ischaemic stroke None Nervous system disorders None View
Myasthenia gravis None Nervous system disorders None View
Presyncope None Nervous system disorders None View
Syncope None Nervous system disorders None View
Bipolar disorder None Psychiatric disorders None View
Confusional state None Psychiatric disorders None View
Fear of falling None Psychiatric disorders None View
Major depression None Psychiatric disorders None View
Pseudodementia None Psychiatric disorders None View
Suicide attempt None Psychiatric disorders None View
renal disorder None Renal and urinary disorders None View
Renal mass None Renal and urinary disorders None View
Pelvic pain None Reproductive system and breast disorders None View
Vaginal prolapse None Reproductive system and breast disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Haemoptysis None Respiratory, thoracic and mediastinal disorders None View
Pneumonia aspiration None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Pulmonary oedema None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Bladder catheter replacement None Surgical and medical procedures None View
Drug delivery device implantation None Surgical and medical procedures None View
Subdural haematoma evacuation None Surgical and medical procedures None View
Aortic aneurysm None Vascular disorders None View
Aortic stenosis None Vascular disorders None View
Deep vein thrombosis None Vascular disorders None View
Hypertension None Vascular disorders None View
Hypotension None Vascular disorders None View
Intermittent claudication None Vascular disorders None View
Peripheral vascular disorder None Vascular disorders None View
Anaemia None Blood and lymphatic system disorders None View
Plasmacytosis None Blood and lymphatic system disorders None View
Spleen disorder None Blood and lymphatic system disorders None View
Acute coronary syndrome None Cardiac disorders None View
Acute myocardial infarction None Cardiac disorders None View
Arrhythmia None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiac arrest None Cardiac disorders None View
Cardiac failure None Cardiac disorders None View
Cardiac failure acute None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Dizziness None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Unstable angina None Cardiac disorders None View
Cataract None Eye disorders None View
Abdominal pain None Gastrointestinal disorders None View
Diverticulum None Gastrointestinal disorders None View
Inguinal hernia None Gastrointestinal disorders None View
Intestinal functional disorder None Gastrointestinal disorders None View
Intestinal perforation None Gastrointestinal disorders None View
Intestinal prolapse None Gastrointestinal disorders None View
Mesenteric artery embolism None Gastrointestinal disorders None View
Pancreatitis acute None Gastrointestinal disorders None View
Rectal haemorrhage None Gastrointestinal disorders None View
Subileus None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Chest pain None General disorders None View
Cholecystitis acute None Hepatobiliary disorders None View
Cholelithiasis None Hepatobiliary disorders None View
Abscess None Infections and infestations None View
Bronchitis None Infections and infestations None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Oedema peripheral None General disorders None View
Pain None General disorders None View
Herpes zoster None Infections and infestations None View
Urinary tract infection None Infections and infestations None View
Fall None Injury, poisoning and procedural complications None View
Rib fracture None Injury, poisoning and procedural complications None View
Spinal compression fracture None Injury, poisoning and procedural complications None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Motor dysfunction None Nervous system disorders None View
Reflexes abnormal None Nervous system disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View