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 @ 12:03 PM
Ignite Modification Date: 2025-12-25 @ 11:58 AM
NCT ID: NCT00744861
Description: None
Frequency Threshold: 2
Time Frame: 12 months post treatment start
Study: NCT00744861
Study Brief: Ultrasound as Adjunct Therapy for Increasing Fusion Success After Lumbar Surgery
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Exogen 4000+ Sham Stage 1 Feasibility: Exogen 4000+ sham, inactive single transducer None None 1 8 5 8 View
Exogen 4000+ Stage 1 Feasibility: Exogen 4000+, active single transducer None None 0 10 7 10 View
Exospine Sham Stage 2 Pivotal: Exospine sham dual transducers None None 23 156 56 156 View
Exospine Stage 2 Pivotal: Exospine active dual transducers None None 18 154 59 154 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Atrial fibrilation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Cardiac arrest NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Meningocele NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA View
Abdominal pain lower NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA View
Incision site infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Lobar pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Wound infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Failure of implant NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Scapula fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Tendon rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Colon cancer stage IV NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA View
Coronary artery occlusion NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Pericarditis NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Supraventricular tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Tachycardia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA View
Non-cardiac chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Chest pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA View
Cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Escherichia urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Gastroenteritis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Purulen discharge NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Pyelonephritis acute NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Viral infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA View
Overdose NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Post procedural discharge NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Spinal compression fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Dyslipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Osteonecrosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Tonsil cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA View
Migraine NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Stupor NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Uterovaginal prolapse NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA View
Pleural effusion NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Knee arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA View
Arterial stenosis limb NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Spondylolisthesis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Rhabdomyolysis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Convulsion NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Bipolar disorder NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA View
Renal cyst NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Renal failure NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Pulmonary embolism NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Nephrolithiasis NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA View
Vitamin D deficiency NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA View
Ligament sprain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Radicular pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Radiculitis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Paraesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View
Incision site complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA View
Bone pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA View
Lumbar radiculopathy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA View