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: 2025-12-25 @ 4:08 AM
Ignite Modification Date: 2025-12-26 @ 3:05 AM
NCT ID: NCT01151020
Description: None
Frequency Threshold: 5
Time Frame: 5 years
Study: NCT01151020
Study Brief: TX2® Low Profile TAA Endovascular Graft
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Zenith® TX2® Low Profile TAA Endovascular Graft Endovascular treatment of patients with aneurysms/ulcers of the descending thoracic aorta having morphology suitable for endovascular repair 25 None 86 110 0 110 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
coagulopathy SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
thrombocytopenia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
angina pectoris SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac arrest SYSTEMATIC_ASSESSMENT Cardiac disorders None View
cardiac failure congestive SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocardial infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
myocardial ischaemia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
ventricular tachycardai SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Intestinal Ischaemia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
aorto-oesophageal fistula SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
dysphagia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
ileus SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
inguinal hernia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pneumoperitoneum SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Vascular injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
brain contusion SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
femoral neck fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
foreign body SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
incisional hernia SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
patella fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
spinal compression fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
subdural hematoma SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
compartment syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
muscular weakness SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spinal ligament ossification SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
spinal osteoarthritis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Gastric cancer stage II SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
bladder cancer recurrent SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
colon adenoma SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
colon cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
gastric cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
blindness unilateral SYSTEMATIC_ASSESSMENT Eye disorders None View
cataract SYSTEMATIC_ASSESSMENT Eye disorders None View
abdominal pain lower SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
gastrointestinal haemorrhage SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
oesophageal dysplasia SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
pelvic floor dysfunction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
small intestinal obstruction SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
chest pain SYSTEMATIC_ASSESSMENT General disorders None View
multiple organ dysfunction syndrome SYSTEMATIC_ASSESSMENT General disorders None View
stent-graft endoleak SYSTEMATIC_ASSESSMENT General disorders None View
cholecystitis acute SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
anaphylactic reaction SYSTEMATIC_ASSESSMENT Immune system disorders None View
contrast media allergy SYSTEMATIC_ASSESSMENT Immune system disorders None View
abdominal wall abscess SYSTEMATIC_ASSESSMENT Infections and infestations None View
abdominal wall infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
arthritis bacterial SYSTEMATIC_ASSESSMENT Infections and infestations None View
diverticulitis SYSTEMATIC_ASSESSMENT Infections and infestations None View
diverticulitis intestinal perforated SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastroenteritis SYSTEMATIC_ASSESSMENT Infections and infestations None View
gastrointestinal infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
influenza SYSTEMATIC_ASSESSMENT Infections and infestations None View
pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
sepsis SYSTEMATIC_ASSESSMENT Infections and infestations None View
urinary tract infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
hip fracture SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
post laminectomy syndrome SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
pseudoaneurysm SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
respiratory fume inhalation disorder SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
spinal column injury SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
blood creatinine increased SYSTEMATIC_ASSESSMENT Investigations None View
gout SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
malnutrition SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
arthralgia SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
joint swelling SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
lumbar spinal stenosis SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
musculoskeletal pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
rotator cuff syndrome SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
non-small cell lung cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
skin cancer SYSTEMATIC_ASSESSMENT Neoplasms benign, malignant and unspecified (incl cysts and polyps) None View
Generalized tonic-clonic seizure SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Subarachnoid haemorrhage SYSTEMATIC_ASSESSMENT Nervous system disorders None View
aphasia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
carotid artery stenosis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
cerebrovascular accident SYSTEMATIC_ASSESSMENT Nervous system disorders None View
paraparesis SYSTEMATIC_ASSESSMENT Nervous system disorders None View
parkinsonism SYSTEMATIC_ASSESSMENT Nervous system disorders None View
syncope SYSTEMATIC_ASSESSMENT Nervous system disorders None View
device electrical finding SYSTEMATIC_ASSESSMENT Product Issues None View
delirium SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nephropathy toxic SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
calculus urinary SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
chronic kidney disease SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
renal failure SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
urinary incontinence SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
prostatitis SYSTEMATIC_ASSESSMENT Reproductive system and breast disorders None View
acute respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
aorto-bronchial fistula SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
bronchial secretion retention SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
chronic obstructive pulmonary disease SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
haemoptysis SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pneumonia aspiration SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary embolism SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
pulmonary haematoma SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
respiratory failure SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Soft tissue excision SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
craniotomy SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
percutaneous coronary intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
aortic aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
haematoma SYSTEMATIC_ASSESSMENT Vascular disorders None View
haemmorrhage SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
hypotension SYSTEMATIC_ASSESSMENT Vascular disorders None View
iliac artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
iliac artery stenosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
ischaemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
peripheral arterial occlusive disease SYSTEMATIC_ASSESSMENT Vascular disorders None View
peripheral artery occlusion SYSTEMATIC_ASSESSMENT Vascular disorders None View
vascular dissection SYSTEMATIC_ASSESSMENT Vascular disorders None View
vascular rupture SYSTEMATIC_ASSESSMENT Vascular disorders None View
ATRIAL FIBRILLATION SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CARDIAC FAILURE SYSTEMATIC_ASSESSMENT Cardiac disorders None View
CORONARY ARTERY STENOSIS SYSTEMATIC_ASSESSMENT Cardiac disorders None View
RETROPERITONEAL HAEMATOMA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
DEATH SYSTEMATIC_ASSESSMENT General disorders None View
VASCULAR STENT THROMBOSIS SYSTEMATIC_ASSESSMENT General disorders None View
CHOLANGITIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
CHOLELITHIASIS SYSTEMATIC_ASSESSMENT Hepatobiliary disorders None View
OSTEOMYELITIS SYSTEMATIC_ASSESSMENT Infections and infestations None View
HERPES ZOSTER SYSTEMATIC_ASSESSMENT Infections and infestations None View
ABSCESS LIMB SYSTEMATIC_ASSESSMENT Infections and infestations None View
FEMUR FRACTURE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
POST PROCEDURAL HAEMMORRHAGE SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
BACK PAIN SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
BONE METABOLISM DISORDER SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
MUSCLE RUPTURE SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
POLYMYALGIA RHEUMATICA SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
URETHRAL STENOSIS SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
URINARY RETENTION SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
LUNG OPACITY SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PLEURAL EFFUSION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY CONGESTION SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
PULMONARY OEDEMA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DECUBITUS ULCER SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
STASIS DERMATITIS SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
MEDICAL DEVICE REMOVAL SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
RENAL DISORDER PROPHYLAXIS SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
STENT PLACEMENT SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
ABDOMINAL ADHESIONS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
PAPILLA OF VATER STENOSIS SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
MULTIPLE FRACTURES SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
BURSITIS SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
MENTAL STATUS CHANGES SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
DEPENDENCE ON VENTILATOR SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
DYSPNOEA SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
NAUSEA SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):