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 @ 2:22 PM
Ignite Modification Date:
2025-12-25 @ 12:59 PM
NCT ID:
NCT00905359
Description:
None
Frequency Threshold:
0.0
Time Frame:
Overall study period, up to 24 months
Study:
NCT00905359
Study Brief:
Neurogenic Intermittent Claudication Evaluation 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 |
|---|---|---|---|---|---|---|---|---|
| Standalone Decompressive Surgery | Patients randomized to this arm received Standalone Decompressive Surgery, defined as decompressive surgery without instrumentation or fusion. | None | None | 25 | 75 | 57 | 75 | View |
| Aperius™ PercLID™ System | Patients randomized to this arm underwent treatment with the Aperius™ PercLID™ System. | None | None | 26 | 77 | 53 | 77 | View |
Serious Events(If Any):
Serious Events
| Term | Type | Organ System | Vocab | View |
|---|---|---|---|---|
| Gastric ulcer | None | Gastrointestinal disorders | None | View |
| Gastritis | None | Gastrointestinal disorders | None | View |
| Hernia | None | General disorders | None | View |
| Non-cardiac chest pain | None | General disorders | None | View |
| Implant site infection | None | Infections and infestations | None | View |
| Orchitis | None | Infections and infestations | None | View |
| Parotitis | None | Infections and infestations | None | View |
| Pharyngotonsillitis | None | Infections and infestations | None | View |
| Confusion postoperative | None | Injury, poisoning and procedural complications | None | View |
| Dural tear | None | Injury, poisoning and procedural complications | None | View |
| Extradural haematoma | None | Injury, poisoning and procedural complications | None | View |
| Foot fracture | None | Injury, poisoning and procedural complications | None | View |
| Back pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Coronary arterial stent insertion | None | Surgical and medical procedures | None | View |
| Gastric banding reversal | None | Surgical and medical procedures | None | View |
| Cerebrovascular accident | None | Vascular disorders | None | View |
| Femoral artery occlusion | None | Vascular disorders | None | View |
| Peripheral artery stenosis | None | Vascular disorders | None | View |
| Thrombosis | None | Vascular disorders | None | View |
| Anemia | None | Blood and lymphatic system disorders | None | View |
| Arteriosclerosis coronary artery | None | Cardiac disorders | None | View |
| Bradycardia | None | Cardiac disorders | None | View |
| Chest pain | None | Cardiac disorders | None | View |
| Sick sinus syndrome | None | Cardiac disorders | None | View |
| Vertigo | None | Ear and labyrinth disorders | None | View |
| Lumbar vertebral fracture | None | Injury, poisoning and procedural complications | None | View |
| Neurological and psychiatric procedural complications | None | Injury, poisoning and procedural complications | None | View |
| Toxicity to various agents | None | Injury, poisoning and procedural complications | None | View |
| Gout | None | Metabolism and nutrition disorders | None | View |
| Hyponatraemia | 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 |
| Intervertebral disc protrusion | None | Musculoskeletal and connective tissue disorders | None | View |
| Lumbar spinal stenosis | 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 |
| Spondylolisthesis | None | Musculoskeletal and connective tissue disorders | None | View |
| Abdominal neoplasm | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Breast cancer | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Lung neoplasm malignant | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Facet joint syndrome | None | Nervous system disorders | None | View |
| Ischaemic stroke | None | Nervous system disorders | None | View |
| Peroneal nerve palsy | None | Nervous system disorders | None | View |
| Radiculitis lumbosacral | None | Nervous system disorders | None | View |
| Sciatica | None | Nervous system disorders | None | View |
| Spinal claudication | None | Nervous system disorders | None | View |
| Subdural haematoma | None | Nervous system disorders | None | View |
| Vertebral foraminal stenosis | None | Nervous system disorders | None | View |
| Cystocele | None | Renal and urinary disorders | None | View |
| Urinary retention | None | Renal and urinary 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 |
|---|---|---|---|---|
| Bradycardia | None | Cardiac disorders | None | View |
| Vertigo | None | Ear and labyrinth disorders | None | View |
| Constipation | None | Gastrointestinal disorders | None | View |
| Dyspepsia | None | Gastrointestinal disorders | None | View |
| Faecal inconsistence | None | Gastrointestinal disorders | None | View |
| Nausea | None | Gastrointestinal disorders | None | View |
| Chest pain | None | General disorders | None | View |
| Fatigue | None | General disorders | None | View |
| Oedema peripheral | None | General disorders | None | View |
| Bronchitis | None | Infections and infestations | None | View |
| Diverticulitis | None | Infections and infestations | None | View |
| Infection | None | Infections and infestations | None | View |
| Influenza | None | Infections and infestations | None | View |
| Localised infection | None | Infections and infestations | None | View |
| Nasopharyngitis | None | Infections and infestations | None | View |
| Pharyngitis | None | Infections and infestations | None | View |
| Prostate infection | None | Infections and infestations | None | View |
| Rhinitis | None | Infections and infestations | None | View |
| Ankle fracture | None | Injury, poisoning and procedural complications | None | View |
| Back injury | None | Injury, poisoning and procedural complications | None | View |
| Confusion | None | Injury, poisoning and procedural complications | None | View |
| Dural tear | None | Injury, poisoning and procedural complications | None | View |
| Factured coccyx | None | Injury, poisoning and procedural complications | None | View |
| Factured sacrum | None | Injury, poisoning and procedural complications | None | View |
| Limb injury | None | Injury, poisoning and procedural complications | None | View |
| Muscle injury | None | Injury, poisoning and procedural complications | None | View |
| Post procedural constipation | None | Injury, poisoning and procedural complications | None | View |
| Post procedural haematoma | None | Injury, poisoning and procedural complications | None | View |
| Post-traumatic pain | None | Injury, poisoning and procedural complications | None | View |
| Procedural nausea | None | Injury, poisoning and procedural complications | None | View |
| Procedural pain | None | Injury, poisoning and procedural complications | None | View |
| Spinal fracture | None | Injury, poisoning and procedural complications | None | View |
| Subcutaneous haematoma | None | Injury, poisoning and procedural complications | None | View |
| Wound complication | None | Injury, poisoning and procedural complications | None | View |
| Wound discence | None | Injury, poisoning and procedural complications | None | View |
| Wound infection | None | Injury, poisoning and procedural complications | None | View |
| Wrist fracture | None | Injury, poisoning and procedural complications | None | View |
| Biopsy stomach | None | Investigations | 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 |
| Buttock pain Musculoskeletal pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Epicondylitis | None | Musculoskeletal and connective tissue disorders | None | View |
| Facial bones fracture | None | Musculoskeletal and connective tissue disorders | None | View |
| Groin pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Intervertebral disc compression | 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 dislocation | None | Musculoskeletal and connective tissue disorders | None | View |
| Lumbar spinal stenosis | None | Musculoskeletal and connective tissue disorders | None | View |
| Muscle spasms | 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 |
| Myalgia | None | Musculoskeletal and connective tissue disorders | None | View |
| Neck pain | None | Musculoskeletal and connective tissue disorders | None | View |
| Osteitis | 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 |
| Rib fracture | 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 |
| Synovial cyst | None | Musculoskeletal and connective tissue disorders | None | View |
| Tendonitis | None | Musculoskeletal and connective tissue disorders | None | View |
| Tenosynovitis | None | Musculoskeletal and connective tissue disorders | None | View |
| Basal cell carcinoma | None | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | None | View |
| Carpal tunnel syndrome | None | Nervous system disorders | None | View |
| Dysaesthesia | None | Nervous system disorders | None | View |
| Headache | None | Nervous system disorders | None | View |
| Hypoaesthesia | None | Nervous system disorders | None | View |
| Loss of consciousness | None | Nervous system disorders | None | View |
| Meralgia paraesthetica | None | Nervous system disorders | None | View |
| Neuropathy peripheral | None | Nervous system disorders | None | View |
| Parkinson's disease | None | Nervous system disorders | None | View |
| Radiculitis lumbosacral | None | Nervous system disorders | None | View |
| Restless legs syndrome | None | Nervous system disorders | None | View |
| Sciatica | None | Nervous system disorders | None | View |
| Sensory abnormalities NEC | None | Nervous system disorders | None | View |
| Sensory disturbance | None | Nervous system disorders | None | View |
| Depression | None | Psychiatric disorders | None | View |
| Insomnia | None | Psychiatric disorders | None | View |
| Nephrolithiasis | None | Renal and urinary disorders | None | View |
| Nocturia | None | Renal and urinary disorders | None | View |
| Dyspnoea exertional | None | Respiratory, thoracic and mediastinal disorders | None | View |
| Dermatitis allergic | None | Skin and subcutaneous tissue disorders | None | View |
| Impetigo | None | Skin and subcutaneous tissue disorders | None | View |
| Prurigo | None | Skin and subcutaneous tissue disorders | None | View |
| Pruritus | None | Skin and subcutaneous tissue disorders | None | View |
| Aortic aneurysm | None | Vascular disorders | None | View |
| Hypertension | None | Vascular disorders | None | View |
| Abdominal pain upper | None | Gastrointestinal disorders | None | View |
| Anal fissure | None | Gastrointestinal disorders | None | View |
| Sacroiliitis | None | Musculoskeletal and connective tissue disorders | None | View |
| Spinal fracture | None | Musculoskeletal and connective tissue disorders | None | View |
| Syncope | None | Nervous system disorders | None | View |