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 @ 12:47 PM
Ignite Modification Date: 2025-12-25 @ 12:15 PM
NCT ID: NCT01566461
Description: None
Frequency Threshold: 5
Time Frame: None
Study: NCT01566461
Study Brief: IN.PACT Admiral Drug-Coated Balloon vs. Standard Balloon Angioplasty for the Treatment of Superficial Femoral Artery (SFA) and Proximal Popliteal Artery (PPA)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Drug-Coated Balloon (DCB) Paclitaxel drug-coated angioplasty balloon IN.PACT Admiral Drug-Coated Balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm None None 102 220 104 220 View
Standard PTA Standard angioplasty balloon without Paclitaxel drug-coating Standard angioplasty balloon: Subjects will be randomized 2:1 to the IN.PACT Admiral Drug-Coated Balloon Arm or to the standard angioplasty balloon Arm None None 62 111 62 111 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Abdominal Pain None Gastrointestinal disorders MedDRA 13.0 View
Acute Coronary Syndrome None Cardiac disorders MedDRA 13.0 View
Acute Myocardial Infarction None Cardiac disorders MedDRA 13.0 View
Acute Pulmonary Oedema None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Adverse Drug Reaction None General disorders MedDRA 13.0 View
Amnesia None Nervous system disorders MedDRA 13.0 View
Anaemia None Blood and lymphatic system disorders MedDRA 13.0 View
MedDRA 13.0 None Gastrointestinal disorders MedDRA 13.0 View
Angina Pectoris None Cardiac disorders MedDRA 13.0 View
Angina Unstable None Cardiac disorders MedDRA 13.0 View
Aorto-Duodenal Fistula None Vascular disorders MedDRA 13.0 View
Arrhythmia None Cardiac disorders MedDRA 13.0 View
Arterial Occlusive Disease None Vascular disorders MedDRA 13.0 View
Arterial Restenosis None Injury, poisoning and procedural complications MedDRA 13.0 View
Arterial Stenosis Limb None Vascular disorders MedDRA 13.0 View
Arterial Thrombosis Limb None Vascular disorders MedDRA 13.0 View
Arteriovenous Fistula None Vascular disorders MedDRA 13.0 View
Artery Dissection None Vascular disorders MedDRA 13.0 View
Arthritis Bacterial None Infections and infestations MedDRA 13.0 View
Atrial Fibrillation None Cardiac disorders MedDRA 13.0 View
Back Pain None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Basal Cell Carcinoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Bile Duct Obstruction None Hepatobiliary disorders MedDRA 13.0 View
Biliary Sepsis None Infections and infestations MedDRA 13.0 View
Bladder Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Bronchiectasis None Infections and infestations MedDRA 13.0 View
Cardiac Arrest None Cardiac disorders MedDRA 13.0 View
Cardiac Failure Congestive None Cardiac disorders MedDRA 13.0 View
Carotid Artery Disease None Nervous system disorders MedDRA 13.0 View
Carotid Artery Stenosis None Nervous system disorders MedDRA 13.0 View
Cellulitis None Infections and infestations MedDRA 13.0 View
Cerebral Infarction None Nervous system disorders MedDRA 13.0 View
Cerebrovascular Accident None Nervous system disorders MedDRA 13.0 View
Chest Pain None General disorders MedDRA 13.0 View
Cholecystitis None Hepatobiliary disorders MedDRA 13.0 View
Chronic Obstructive Pulmonary Disease None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Colon Cancer Metastatic None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Coronary Artery Disease None Cardiac disorders MedDRA 13.0 View
Coronary Artery Thrombosis None Cardiac disorders MedDRA 13.0 View
Device Occlusion None General disorders MedDRA 13.0 View
Device Related Infection None Infections and infestations MedDRA 13.0 View
Diabetic Foot None Metabolism and nutrition disorders MedDRA 13.0 View
Diabetic Retinopathy None Eye disorders MedDRA 13.0 View
Dry Gangrene None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Dyspnoea Exertional None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Embolic Cerebral Infarction None Nervous system disorders MedDRA 13.0 View
Exostosis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Facial Bones Fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Fall None Injury, poisoning and procedural complications MedDRA 13.0 View
Femoral Arterial Stenosis None Vascular disorders MedDRA 13.0 View
Femoral Artery Dissection None Vascular disorders MedDRA 13.0 View
Femoral Artery Occlusion None Vascular disorders MedDRA 13.0 View
Femoral Neck Fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Fibula Fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Fractured Coccyx None Injury, poisoning and procedural complications MedDRA 13.0 View
Gangrene None Infections and infestations MedDRA 13.0 View
Gastroenteritis None Infections and infestations MedDRA 13.0 View
Gastrointestinal Haemorrhage None Gastrointestinal disorders MedDRA 13.0 View
Gastrooesophageal Reflux Disease None Gastrointestinal disorders MedDRA 13.0 View
Haematoma None Vascular disorders MedDRA 13.0 View
Haematuria None Renal and urinary disorders MedDRA 13.0 View
Haemorrhage None Vascular disorders MedDRA 13.0 View
Haemorrhage Intracranial None Nervous system disorders MedDRA 13.0 View
Haemorrhagic Anaemia None Blood and lymphatic system disorders MedDRA 13.0 View
Hepatic Cirrhosis None Hepatobiliary disorders MedDRA 13.0 View
Hyperglycaemia None Metabolism and nutrition disorders MedDRA 13.0 View
Hyperkalaemia None Metabolism and nutrition disorders MedDRA 13.0 View
Hypoaesthesia None Nervous system disorders MedDRA 13.0 View
Hypotension None Vascular disorders MedDRA 13.0 View
Iliac Artery Occlusion None Vascular disorders MedDRA 13.0 View
Iliac Artery Stenosis None Vascular disorders MedDRA 13.0 View
Impaired Gastric Emptying None Gastrointestinal disorders MedDRA 13.0 View
Impaired Healing None General disorders MedDRA 13.0 View
Implant Site Thrombosis None General disorders MedDRA 13.0 View
In-Stent Arterial Restenosis None Injury, poisoning and procedural complications MedDRA 13.0 View
In-Stent Coronary Artery Restenosis None Injury, poisoning and procedural complications MedDRA 13.0 View
Infected Lymphocele None Infections and infestations MedDRA 13.0 View
Intermittent Claudication None Vascular disorders MedDRA 13.0 View
Intervertebral Disc Protrusion None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Intestinal Obstruction None Gastrointestinal disorders MedDRA 13.0 View
Joint Surgery None Surgical and medical procedures MedDRA 13.0 View
Large Intestine Perforation None Gastrointestinal disorders MedDRA 13.0 View
Lipoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Liver Disorder None Hepatobiliary disorders MedDRA 13.0 View
Localised Infection None Infections and infestations MedDRA 13.0 View
Lumbar Radiculopathy None Nervous system disorders MedDRA 13.0 View
Lumbar Spinal Stenosis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Lumbar Vertebral Fracture None Injury, poisoning and procedural complications MedDRA 13.0 View
Malignant Melanoma None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Mass None General disorders MedDRA 13.0 View
Melaena None Gastrointestinal disorders MedDRA 13.0 View
Mental Status Changes None Psychiatric disorders MedDRA 13.0 View
Multi-Organ Failure None General disorders MedDRA 13.0 View
Musculoskeletal Pain None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Myocardial Infarction None Cardiac disorders MedDRA 13.0 View
Myocardial Ischaemia None Cardiac disorders MedDRA 13.0 View
Necrosis None General disorders MedDRA 13.0 View
Neuropathic Ulcer None Skin and subcutaneous tissue disorders MedDRA 13.0 View
Obesity None Metabolism and nutrition disorders MedDRA 13.0 View
Oedema Peripheral None General disorders MedDRA 13.0 View
Orthostatic Hypotension None Vascular disorders MedDRA 13.0 View
Osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Osteomyelitis None Infections and infestations MedDRA 13.0 View
Overdose None Injury, poisoning and procedural complications MedDRA 13.0 View
Pain In Extremity None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Pancreatitis None Gastrointestinal disorders MedDRA 13.0 View
Pancytopenia None Blood and lymphatic system disorders MedDRA 13.0 View
Paraesthesia None Nervous system disorders MedDRA 13.0 View
Peptic Ulcer None Gastrointestinal disorders MedDRA 13.0 View
Peripheral Arterial Occlusive Disease None Vascular disorders MedDRA 13.0 View
Peripheral Arterial Reocclusion None Injury, poisoning and procedural complications MedDRA 13.0 View
Peripheral Artery Dissection None Vascular disorders MedDRA 13.0 View
Peripheral Vascular Disorder None Vascular disorders MedDRA 13.0 View
Peritonitis None Gastrointestinal disorders MedDRA 13.0 View
Pneumonia None Infections and infestations MedDRA 13.0 View
Polyp None General disorders MedDRA 13.0 View
Postmenopausal Haemorrhage None Reproductive system and breast disorders MedDRA 13.0 View
Prostate Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Prostatic Specific Antigen Increased None Investigations MedDRA 13.0 View
Renal Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Renal Colic None Renal and urinary disorders MedDRA 13.0 View
Renal Failure None Renal and urinary disorders MedDRA 13.0 View
Renal Failure Acute None Renal and urinary disorders MedDRA 13.0 View
Respiratory Failure None Respiratory, thoracic and mediastinal disorders MedDRA 13.0 View
Sepsis None Infections and infestations MedDRA 13.0 View
Shock Haemorrhagic None Vascular disorders MedDRA 13.0 View
Sinus Tachycardia None Cardiac disorders MedDRA 13.0 View
Small Intestinal Obstruction None Gastrointestinal disorders MedDRA 13.0 View
Spinal Column Stenosis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spinal Osteoarthritis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Spondylolisthesis None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Subclavian Artery Stenosis None Vascular disorders MedDRA 13.0 View
Sudden Death None General disorders MedDRA 13.0 View
Supraventricular Tachycardia None Cardiac disorders MedDRA 13.0 View
Syncope None Nervous system disorders MedDRA 13.0 View
Synovial Cyst None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Therapeutic Embolisation None Surgical and medical procedures MedDRA 13.0 View
Tonsil Cancer None Neoplasms benign, malignant and unspecified (incl cysts and polyps) MedDRA 13.0 View
Transient Ischaemic Attack None Nervous system disorders MedDRA 13.0 View
Urinary Tract Infection None Infections and infestations MedDRA 13.0 View
Vascular Graft Occlusion None Injury, poisoning and procedural complications MedDRA 13.0 View
Vascular Pseudoaneurysm None Injury, poisoning and procedural complications MedDRA 13.0 View
Ventricular Tachycardia None Cardiac disorders MedDRA 13.0 View
Vertigo None Ear and labyrinth disorders MedDRA 13.0 View
Vessel Puncture Site Haematoma None General disorders MedDRA 13.0 View
West Nile Viral Infection None Infections and infestations MedDRA 13.0 View
Peripheral Embolism None Vascular disorders MedDRA 13.0 View
Peripheral Ischaemia None Vascular disorders MedDRA 13.0 View
Peripheral Revascularisation None Surgical and medical procedures MedDRA 13.0 View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Artery Dissection None Vascular disorders MedDRA 13.0 View
Femoral Artery Dissection None Vascular disorders MedDRA 13.0 View
Intermittent Claudication None Vascular disorders MedDRA 13.0 View
Pain In Extremity None Musculoskeletal and connective tissue disorders MedDRA 13.0 View
Peripheral Artery Dissection None Vascular disorders MedDRA 13.0 View
Vessel Puncture Site Haematoma None General disorders MedDRA 13.0 View