Adverse Events Module

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 @ 11:54 PM
Ignite Modification Date: 2025-12-25 @ 9:49 PM
NCT ID: NCT00517751
Description: Due to early study termination, not all subjects were followed through 60 months.
Frequency Threshold: 0.0
Time Frame: Overall study period (up to 60 months)
Study: NCT00517751
Study Brief: Condition of Approval Study
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
X-STOP PEEK In this arm, patients will undergo X-STOP PEEK surgery. None None 65 162 118 162 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Cervical spinal stenosis None Musculoskeletal and connective tissue disorders None View
Fracture nonunion None Musculoskeletal and connective tissue disorders None View
Intervertebral disc degeneration None Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders None View
Joint ankylosis None Musculoskeletal and connective tissue disorders None View
Lumbar spinal stenosis None Musculoskeletal and connective tissue disorders None View
Muscular weakness None Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Periarthritis None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Sacroiliitis None Musculoskeletal and connective tissue disorders None View
Scoliosis None Musculoskeletal and connective tissue disorders None View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders None View
Spondylolisthesis None Musculoskeletal and connective tissue disorders None View
Vertebral foraminal stenosis None Musculoskeletal and connective tissue disorders None View
Breast cancer in situ None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Metastatic malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Morton's neuroma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Non-hodgkin's lymphoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Hypoaesthesia None Nervous system disorders None View
Intracranial hypotension None Nervous system disorders None View
Lumbar radiculopathy None Nervous system disorders None View
Radiculopathy None Nervous system disorders None View
Sensory disturbance None Nervous system disorders None View
Spinal claudication None Nervous system disorders None View
Delusion None Psychiatric disorders None View
Hallucination None Psychiatric disorders None View
Renal failure None Renal and urinary disorders None View
Renal failure acute None Renal and urinary disorders None View
Urinary retention None Renal and urinary disorders None View
Cervical polyp None Reproductive system and breast disorders None View
Aspiration None Respiratory, thoracic and mediastinal disorders None View
Bronchitis None Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Hypoxia None Respiratory, thoracic and mediastinal disorders None View
Lung infiltration None Respiratory, thoracic and mediastinal disorders None View
Activities of daily living impaired None Social circumstances None View
Abdominal hernia repair None Surgical and medical procedures None View
Carotid endarterectomy None Surgical and medical procedures None View
External fixation of fracture None Surgical and medical procedures None View
Hip arthroplasty None Surgical and medical procedures None View
Joint dislocation reduction None Surgical and medical procedures None View
Leg amputation None Surgical and medical procedures None View
Medical device removal None Surgical and medical procedures None View
Shoulder arthroplasty None Surgical and medical procedures None View
Aortic aneurysm None Vascular disorders None View
Deep vein thrombosis None Vascular disorders None View
Hematoma None Vascular disorders None View
Hypotension None Vascular disorders None View
Iliac artery thrombosis None Vascular disorders None View
Vascular insufficiency None Vascular disorders None View
Myocarditis None Cardiac disorders None View
Supraventricular tachycardia None Cardiac disorders None View
Ventricular tachycardia None Cardiac disorders None View
Ear pain None Ear and labyrinth disorders None View
Haematotympanum None Ear and labyrinth disorders None View
Cataract None Eye disorders None View
Cataract cortical None Eye disorders None View
Macular hole None Eye disorders None View
Diverticulum None Gastrointestinal disorders None View
Gastrointestinal haemorrhage None Gastrointestinal disorders None View
Gastrooesophageal reflux disease None Gastrointestinal disorders None View
Oesophageal ulcer haemorrhage None Gastrointestinal disorders None View
Rectal fissure None Gastrointestinal disorders None View
Adverse drug reaction None General disorders None View
Death None General disorders None View
Device dislocation None General disorders None View
Device ineffective None General disorders None View
Gait disturbance None General disorders None View
Medical device pain None General disorders None View
Pyrexia None General disorders None View
Anal abscess None Infections and infestations None View
Cellulitis None Infections and infestations None View
Clostridial infection None Infections and infestations None View
Device related infection None Infections and infestations None View
Meningitis bacterial None Infections and infestations None View
Pneumonia None Infections and infestations None View
Post procedural infection None Infections and infestations None View
Postoperative wound infection None Infections and infestations None View
Sepsis None Infections and infestations None View
Wound infection staphylococcal None Infections and infestations None View
Animal bite None Injury, poisoning and procedural complications None View
Ankle fracture None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Hip fracture None Injury, poisoning and procedural complications None View
Incision site complication None Injury, poisoning and procedural complications None View
Injury None Injury, poisoning and procedural complications None View
Joint dislocation None Injury, poisoning and procedural complications None View
Procedural pain None Injury, poisoning and procedural complications None View
Seroma None Injury, poisoning and procedural complications None View
Spinal compression fracture None Injury, poisoning and procedural complications None View
Spinal fracture None Injury, poisoning and procedural complications None View
Toxicity to various agents None Injury, poisoning and procedural complications None View
Urinary retention postoperative None Injury, poisoning and procedural complications None View
Vascular graft complication None Injury, poisoning and procedural complications None View
Wound dehiscence None Injury, poisoning and procedural complications None View
Anticoagulation drug level above therapeutic None Investigations None View
Blood magnesium decreased None Investigations None View
Blood pressure decreased None Investigations None View
Blood pressure increased None Investigations None View
Cardiac stress test abnormal None Investigations None View
Metabolic acidosis None Metabolism and nutrition disorders None View
Total fluid volume decreased None Metabolism and nutrition disorders None View
Anaemia None Blood and lymphatic system disorders None View
Acute myocardial infarction None Cardiac disorders None View
Angina pectoris None Cardiac disorders None View
Atrial fibrillation None Cardiac disorders None View
Cardiac disorder None Cardiac disorders None View
Cardiogenic shock None Cardiac disorders None View
Cardiomyopathy None Cardiac disorders None View
Coronary artery disease None Cardiac disorders None View
Diastolic dysfunction None Cardiac disorders None View
Intracardiac thrombus None Cardiac disorders None View
Myocardial infarction None Cardiac disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Carpal tunnel syndrome None Nervous system disorders None View
Cerebrovascular accident None Nervous system disorders None View
Cervical myelopathy None Nervous system disorders None View
Cervicobrachial syndrome None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Pulmonary embolism None Respiratory, thoracic and mediastinal disorders None View
Respiratory failure None Respiratory, thoracic and mediastinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Duodenal ulcer None Gastrointestinal disorders None View
Dyspepsia None Gastrointestinal disorders None View
Dysphagia None Gastrointestinal disorders None View
Pharyngitis streptococcal None Infections and infestations None View
Hand fracture None Injury, poisoning and procedural complications None View
Radius fracture None Injury, poisoning and procedural complications None View
Rib fracture None Injury, poisoning and procedural complications None View
Anaemia None Blood and lymphatic system disorders None View
Thrombocytopenia None Blood and lymphatic system disorders None View
Atrial fibrillation None Cardiac disorders None View
Bradycardia None Cardiac disorders None View
Cardiac failure congestive None Cardiac disorders None View
Coronary artery disease None Cardiac disorders None View
Diastolic dysfunction None Cardiac disorders None View
Tachycardia None Cardiac disorders None View
Gastrointestinal arteriovenous malformation None Congenital, familial and genetic disorders None View
Ear discomfort None Ear and labyrinth disorders None View
Vertigo None Ear and labyrinth disorders None View
Hypothyroidism None Endocrine disorders None View
Cataract nuclear None Eye disorders None View
Corneal bleeding None Eye disorders None View
Glaucoma None Eye disorders None View
Macular degeneration None Eye disorders None View
Vision blurred None Eye disorders None View
Vitreous floaters None Eye disorders None View
Abdominal discomfort None Gastrointestinal disorders None View
Abdominal distension None Gastrointestinal disorders None View
Abdominal pain None Gastrointestinal disorders None View
Abdominal pain lower None Gastrointestinal disorders None View
Abdominal pain upper None Gastrointestinal disorders None View
Colonic polyp None Gastrointestinal disorders None View
Constipation None Gastrointestinal disorders None View
Crohn's disease None Gastrointestinal disorders None View
Diarrhoea None Gastrointestinal disorders None View
Diverticulitis None Gastrointestinal disorders None View
Diverticulum None Gastrointestinal disorders None View
Faecal incontinence None Gastrointestinal disorders None View
Faecaloma None Gastrointestinal disorders None View
Gastritis None Gastrointestinal disorders None View
Gastrointestinal infection None Gastrointestinal disorders None View
Gastrooesophageal reflux disease None Gastrointestinal disorders None View
Haemorrhoids None Gastrointestinal disorders None View
Levator syndrome None Gastrointestinal disorders None View
Nausea None Gastrointestinal disorders None View
Rectal haemorrhage None Gastrointestinal disorders None View
Vomiting None Gastrointestinal disorders None View
Adverse drug reaction None General disorders None View
Asthenia None General disorders None View
Axillary pain None General disorders None View
Chest pain None General disorders None View
Complication of device insertion None General disorders None View
Device difficult to use None General disorders None View
Device dislocation None General disorders None View
Device material issue None General disorders None View
Fatigue None General disorders None View
Gait disturbance None General disorders None View
Malaise None General disorders None View
Non-cardiac chest pain None General disorders None View
Oedema peripheral None General disorders None View
Pyrexia None General disorders None View
Xerosis None General disorders None View
Autoimmune disorder None Immune system disorders None View
Hypersensitivity None Immune system disorders None View
Acute sinusitis None Infections and infestations None View
Bronchitis None Infections and infestations None View
Candidiasis None Infections and infestations None View
Cystitis None Infections and infestations None View
Gastrointestinal bacterial infection None Infections and infestations None View
Herpes virus infection None Infections and infestations None View
Herpes zoster None Infections and infestations None View
Incision site infection None Infections and infestations None View
Influenza None Infections and infestations None View
Kidney infection None Infections and infestations None View
Laryngitis viral None Infections and infestations None View
Nasopharyngitis None Infections and infestations None View
Oral herpes None Infections and infestations None View
Otitis externa None Infections and infestations None View
Pyelonephritis None Infections and infestations None View
Respiratory tract infection bacterial None Infections and infestations None View
Sinusitis None Infections and infestations None View
Tooth abscess 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
Wound infection staphylococcal None Infections and infestations None View
Anaemia postoperative None Injury, poisoning and procedural complications None View
Back injury None Injury, poisoning and procedural complications None View
Cervical vertebral fracture None Injury, poisoning and procedural complications None View
Clavicle fracture None Injury, poisoning and procedural complications None View
Contusion None Injury, poisoning and procedural complications None View
Corneal abrasion None Injury, poisoning and procedural complications None View
Dural tear None Injury, poisoning and procedural complications None View
Excoriation None Injury, poisoning and procedural complications None View
Fall None Injury, poisoning and procedural complications None View
Femur fracture None Injury, poisoning and procedural complications None View
Gastroenteritis radiation None Injury, poisoning and procedural complications None View
Incision site complication None Injury, poisoning and procedural complications None View
Incision site erythema None Injury, poisoning and procedural complications None View
Incision site haemorrhage None Injury, poisoning and procedural complications None View
Incision site oedema None Injury, poisoning and procedural complications None View
Incision site pain None Injury, poisoning and procedural complications None View
Incision site pruritus None Injury, poisoning and procedural complications None View
Injury None Injury, poisoning and procedural complications None View
Joint injury None Injury, poisoning and procedural complications None View
Ligament injury None Injury, poisoning and procedural complications None View
Ligament rupture None Injury, poisoning and procedural complications None View
Meniscus lesion None Injury, poisoning and procedural complications None View
Muscle strain None Injury, poisoning and procedural complications None View
Operative haemorrhage None Injury, poisoning and procedural complications None View
Postoperative fever None Injury, poisoning and procedural complications None View
Postoperative ileus None Injury, poisoning and procedural complications None View
Postoperative wound complication None Injury, poisoning and procedural complications None View
Procedural pain None Injury, poisoning and procedural complications None View
Road traffic accident None Injury, poisoning and procedural complications None View
Scapula fracture None Injury, poisoning and procedural complications None View
Seroma None Injury, poisoning and procedural complications None View
Soft tissue injury None Injury, poisoning and procedural complications None View
Spinal fracture None Injury, poisoning and procedural complications None View
Tendonitis None Injury, poisoning and procedural complications None View
Upper limb fracture None Injury, poisoning and procedural complications None View
Urinary retention postoperative None Injury, poisoning and procedural complications None View
Wound secretion None Injury, poisoning and procedural complications None View
Blood glucose increased None Investigations None View
Blood potassium increased None Investigations None View
Blood pressure decreased None Investigations None View
Blood pressure increased None Investigations None View
Blood triglycerides increased None Investigations None View
Body temperature increased None Investigations None View
Glysolated haemoglobin increased None Investigations None View
Pulse absent None Investigations None View
Spinal x-ray abnormal None Investigations None View
Weight decreased None Investigations None View
Dehydration None Metabolism and nutrition disorders None View
Diabetes mellitus None Metabolism and nutrition disorders None View
Fluid retention None Metabolism and nutrition disorders None View
Glucose tolerance impaired None Metabolism and nutrition disorders None View
Gout None Metabolism and nutrition disorders None View
Hypercholesterolaemia None Metabolism and nutrition disorders None View
Hyperglycaemia None Metabolism and nutrition disorders None View
Hyperlipidaemia None Metabolism and nutrition disorders None View
Hypokalaemia None Metabolism and nutrition disorders None View
Insulin-requiring type 2 diabetes mellitus None Metabolism and nutrition disorders None View
Arthralgia None Musculoskeletal and connective tissue disorders None View
Arthritis None Musculoskeletal and connective tissue disorders None View
Back pain None Musculoskeletal and connective tissue disorders None View
Bursitis None Musculoskeletal and connective tissue disorders None View
Coccydynia None Musculoskeletal and connective tissue disorders None View
Dupuytren's contracture None Musculoskeletal and connective tissue disorders None View
Facet joint syndrome None Musculoskeletal and connective tissue disorders None View
Flank pain None Musculoskeletal and connective tissue disorders None View
Groin pain None Musculoskeletal and connective tissue disorders None View
Intervertebral disc degeneration None Musculoskeletal and connective tissue disorders None View
Intervertebral disc protrusion None Musculoskeletal and connective tissue disorders None View
Joint swelling None Musculoskeletal and connective tissue disorders None View
Joint contracture None Musculoskeletal and connective tissue disorders None View
Joint crepitation None Musculoskeletal and connective tissue disorders None View
Joint range of motion decreased None Musculoskeletal and connective tissue disorders None View
Lower extremity mass None Musculoskeletal and connective tissue disorders None View
Lumbar spinal stenosis None Musculoskeletal and connective tissue disorders None View
Metatarsalgia None Musculoskeletal and connective tissue disorders None View
Muscle spasms None Musculoskeletal and connective tissue disorders None View
Muscle tightness None Musculoskeletal and connective tissue disorders None View
Muscular weakness None Musculoskeletal and connective tissue disorders None View
Musculoskeletal chest pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal discomfort None Musculoskeletal and connective tissue disorders None View
Musculoskeletal pain None Musculoskeletal and connective tissue disorders None View
Musculoskeletal stiffness None Musculoskeletal and connective tissue disorders None View
Myalgia None Musculoskeletal and connective tissue disorders None View
Neck pain None Musculoskeletal and connective tissue disorders None View
Osteoarthritis None Musculoskeletal and connective tissue disorders None View
Osteopenia None Musculoskeletal and connective tissue disorders None View
Osteoporosis None Musculoskeletal and connective tissue disorders None View
Pain in extremity None Musculoskeletal and connective tissue disorders None View
Periarthritis None Musculoskeletal and connective tissue disorders None View
Plantar fasciitis None Musculoskeletal and connective tissue disorders None View
Rotator cuff syndrome None Musculoskeletal and connective tissue disorders None View
Scoliosis None Musculoskeletal and connective tissue disorders None View
Spinal osteoarthritis None Musculoskeletal and connective tissue disorders None View
Spondylolisthesis None Musculoskeletal and connective tissue disorders None View
Malignant melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Morton's neuroma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Prostate cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Seborrhoeic keratosis None Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Amnesia None Nervous system disorders None View
Carpal tunnel syndrome None Nervous system disorders None View
Cerebral atrophy None Nervous system disorders None View
Cerebral small vessel ischaemic disease None Nervous system disorders None View
Coordination abnormal None Nervous system disorders None View
Diabetic neuropathy None Nervous system disorders None View
Dizziness None Nervous system disorders None View
Headache None Nervous system disorders None View
Hypoaesthesia None Nervous system disorders None View
Lethargy None Nervous system disorders None View
Lumbar radiculopathy None Nervous system disorders None View
Multiple sclerosis None Nervous system disorders None View
Neuralgia None Nervous system disorders None View
Neuropathy peripheral None Nervous system disorders None View
Paraesthesia None Nervous system disorders None View
Poor quality sleep None Nervous system disorders None View
Presyncope None Nervous system disorders None View
Radicular pain None Nervous system disorders None View
Senile dementia None Nervous system disorders None View
Spinal claudication None Nervous system disorders None View
Tarsal tunnel syndrome None Nervous system disorders None View
Agitation None Psychiatric disorders None View
Anxiety None Psychiatric disorders None View
Depression None Psychiatric disorders None View
Flashback None Psychiatric disorders None View
Grief reaction None Psychiatric disorders None View
Insomnia None Psychiatric disorders None View
Sleep disorder None Psychiatric disorders None View
Dysuria None Renal and urinary disorders None View
Haematuria None Renal and urinary disorders None View
Micturition urgency None Renal and urinary disorders None View
Nocturia None Renal and urinary disorders None View
Pollakiuria None Renal and urinary disorders None View
Renal failure None Renal and urinary disorders None View
Strangury None Renal and urinary disorders None View
Urinary retention None Renal and urinary disorders None View
Benign prostatic hyperplasia None Reproductive system and breast disorders None View
Breast cyst None Reproductive system and breast disorders None View
Breast mass None Reproductive system and breast disorders None View
Erectile dysfunction None Reproductive system and breast disorders None View
Gynaecomastia None Reproductive system and breast disorders None View
Vulvovaginal dryness None Reproductive system and breast disorders None View
Asthma None Respiratory, thoracic and mediastinal disorders None View
Bronchial hyperreactivity None Respiratory, thoracic and mediastinal disorders None View
Bronchitis None Respiratory, thoracic and mediastinal disorders None View
Chronic obstructive pulmonary disease None Respiratory, thoracic and mediastinal disorders None View
Cough None Respiratory, thoracic and mediastinal disorders None View
Dysphonia None Respiratory, thoracic and mediastinal disorders None View
Dyspnoea None Respiratory, thoracic and mediastinal disorders None View
Dysponea exertional None Respiratory, thoracic and mediastinal disorders None View
Hiccups None Respiratory, thoracic and mediastinal disorders None View
Interstitial lung disease None Respiratory, thoracic and mediastinal disorders None View
Nasal congestion None Respiratory, thoracic and mediastinal disorders None View
Pneumonia None Respiratory, thoracic and mediastinal disorders None View
Sleep apnoea syndrome None Respiratory, thoracic and mediastinal disorders None View
Tonsillar disorder None Respiratory, thoracic and mediastinal disorders None View
Vocal cord disorder None Respiratory, thoracic and mediastinal disorders None View
Actinic keratosis None Skin and subcutaneous tissue disorders None View
Dermatitis None Skin and subcutaneous tissue disorders None View
Dermatitis contact None Skin and subcutaneous tissue disorders None View
Erythema None Skin and subcutaneous tissue disorders None View
Hyperkeratosis None Skin and subcutaneous tissue disorders None View
Nail disorder None Skin and subcutaneous tissue disorders None View
Pruritus None Skin and subcutaneous tissue disorders None View
Rash None Skin and subcutaneous tissue disorders None View
Seborrheic dermatitis None Skin and subcutaneous tissue disorders None View
Corneal transplant None Surgical and medical procedures None View
Endodontic procedure None Surgical and medical procedures None View
Hip arthroplasty None Surgical and medical procedures None View
Incisional drainage None Surgical and medical procedures None View
Knee arthroplasty None Surgical and medical procedures None View
Medical device removal None Surgical and medical procedures None View
Arterial thrombosis None Vascular disorders None View
Arteriovenous fistula None Vascular disorders None View
Haematoma None Vascular disorders None View
Hypotension None Vascular disorders None View
Peripheral coldness None Vascular disorders None View