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 @ 3:58 PM
Ignite Modification Date: 2025-12-25 @ 2:01 PM
NCT ID: NCT00534092
Description: An adverse event case report form was administered at each follow up visit with routine investigator assessment; adverse events were source verified. Patients may have had multiple adverse events.
Frequency Threshold: 0
Time Frame: 3+ years following first 2 years post-X-STOP implant through IDE study
Study: NCT00534092
Study Brief: Long-Term Outcomes for Lumbar Spinal Stenosis Patients Treated With X STOP®
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Safety Patients who had mildly impaired physical function prior to X-STOP implantation, as determined by a baseline score ≤2.0 in the PF domain of the ZCQ. None None 4 14 13 14 View
Target Patients with impaired physical function prior to X-STOP implantation, as determined by a baseline score \>2.0 in the Physical Function (PF) domain of the Zurich Claudication Questionnaire (ZCQ). None None 11 55 48 55 View
Total Total patients included target group and safety group. None None 15 69 61 69 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Device dislocation NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Wound dehiscence NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
Lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Hip arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Anaemia NON_SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders MedDRA 12.0 View
Gastrointestinal arteriovenous malformation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 12.0 View
Gastritis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Portal hypertensive gastropathy NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Varices oesophageal NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
Device deployment issue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Device failure NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Hypertrophy NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Periprosthetic fracture NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
Intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Musculoskeletal chest pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
Colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
Hydrocephalus NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Spinal claudication NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
Dyspnoea exertional NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
Cardiac pacemaker insertion NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Hip surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Intervertebral disc operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Spinal fusion surgery NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
arrhythmia NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
atrial fibrillation NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
coronary artery disease NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
myocardial infarction NON_SYSTEMATIC_ASSESSMENT Cardiac disorders MedDRA 12.0 View
factor v leiden mutation NON_SYSTEMATIC_ASSESSMENT Congenital, familial and genetic disorders MedDRA 12.0 View
deafness neurosensory NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
hypoacusis NON_SYSTEMATIC_ASSESSMENT Ear and labyrinth disorders MedDRA 12.0 View
acromegaly NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
thyroid disorder NON_SYSTEMATIC_ASSESSMENT Endocrine disorders MedDRA 12.0 View
cataract NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
glaucoma NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
macular degeneration NON_SYSTEMATIC_ASSESSMENT Eye disorders MedDRA 12.0 View
constipation NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
dysphagia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
gastrointestinal haemorrhage NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
gastrooesophageal reflux disease NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
haemorrhoids NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
inguinal hernia NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
nausea NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
oesophageal stenosis NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
vomiting NON_SYSTEMATIC_ASSESSMENT Gastrointestinal disorders MedDRA 12.0 View
asthenia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
chills NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
drug withdrawal syndrome NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
fatigue NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
feeling abnormal NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
hernia NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
oedema peripheral NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
pain NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
polyp NON_SYSTEMATIC_ASSESSMENT General disorders MedDRA 12.0 View
multiple allergies NON_SYSTEMATIC_ASSESSMENT Immune system disorders MedDRA 12.0 View
bronchitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
cellulitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
cystitis NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
influenza NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
pneumonia NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
upper respiratory tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
urinary tract infection NON_SYSTEMATIC_ASSESSMENT Infections and infestations MedDRA 12.0 View
ankle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
clavicle fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
contusion NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
excoriation NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
fall NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
femur fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
ligament rupture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
lumbar vertebral fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
pelvic fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
post-traumatic pain NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
road traffic accident NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
spinal fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
upper limb fracture NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
pedal pulse decreased NON_SYSTEMATIC_ASSESSMENT Investigations MedDRA 12.0 View
diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
gout NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
hyperlipidaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
hypocholesterolaemia NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
type 2 diabetes mellitus NON_SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders MedDRA 12.0 View
arthralgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
arthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
arthropathy NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
back pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
bursitis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
cervical spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
intervertebral disc degeneration NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
intervertebral disc disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
intervertebral disc protrusion NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
limb discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
lumbar spinal stenosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
muscle tightness NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
musculoskeletal discomfort NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
musculoskeletal pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
myalgia NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
neck pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
pain in extremity NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
polychondritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
rotator cuff syndrome NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
scoliosis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
spinal osteoarthritis NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
tendon pain NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
colon cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
lung neoplasm malignant NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
malignant neoplasm of eye NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
multiple myeloma NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
pituitary tumor benign NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
prostate cancer NON_SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 12.0 View
amnesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
ataxia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
carotid artery stenosis NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
carpal tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
cerebrovascular accident NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
cognitive disorder NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
cubital tunnel syndrome NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
headache NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
hypoaesthesia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
neuropathy peripheral NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
occipital neuralgia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
parkinson's disease NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
peroneal nerve palsy NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
radicular pain NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
sciatica NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
spinal claudication NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
transient ischaemic attack NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
vascular dementia NON_SYSTEMATIC_ASSESSMENT Nervous system disorders MedDRA 12.0 View
anxiety NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
depression NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
depressive symptom NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
insomnia NON_SYSTEMATIC_ASSESSMENT Psychiatric disorders MedDRA 12.0 View
incontinence NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
pollakiuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
proteinuria NON_SYSTEMATIC_ASSESSMENT Renal and urinary disorders MedDRA 12.0 View
benign prostatic hyperplasia NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
prostatomegaly NON_SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders MedDRA 12.0 View
chronic obstructive pulmonary disease NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
dyspnoea NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
emphysema NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
rhinitis allergic NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
sleep apnoea syndrome NON_SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders MedDRA 12.0 View
bladder repair NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
cholecystectomy NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
corneal transplant NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
hip arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
injection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
knee arthroplasty NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
knee operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
partial lung resection NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
spinal operation NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
stent placement NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
wound treatment NON_SYSTEMATIC_ASSESSMENT Surgical and medical procedures MedDRA 12.0 View
aortic aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
deep vein thrombosis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
hot flush NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
hypertension NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
intermittent claudication NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
wound complication NON_SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications MedDRA 12.0 View
back disorder NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
muscle spasms NON_SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders MedDRA 12.0 View
erythema nodosum NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
night sweats NON_SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders MedDRA 12.0 View
peripheral artery aneurysm NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
phlebitis NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View
varicose vein NON_SYSTEMATIC_ASSESSMENT Vascular disorders MedDRA 12.0 View