Adverse Events Module

Home

Certify Doc

Genes

Clinical Trials

CompTox

DrugMatrix

Open Targets

Products

Support

Bugs

Main Search Make This Study a Gene Therapy Make This Study a Not Gene Therapy Report Bug

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 @ 9:48 PM

Ignite Modification Date: 2025-12-25 @ 7:27 PM

NCT ID: NCT00844532

Description: Organ systems designations were chosen to match Abbott Categories coding as closely as possible and may differ from other coding systems. The number at risk excludes subjects who were lost to follow-up or withdrew from the study through 3 years without any events.

Frequency Threshold: 5

Time Frame: 3 years

Study: NCT00844532

Study Brief: Trial to Evaluate the Safety & Efficacy of the Absolute Pro™ Peripheral Self-Expanding Stent System in Subjects With Atherosclerotic de Novo or Restenotic Lesions in the Native Common Iliac Artery and/or Native External Iliac Artery.

Event Groups(If Any):

Event Groups

Title	Description	Deaths # Affected	Deaths # At Risk	Serious # Affected	Serious # At Risk	Other # Affected	Other # At Risk	View

Absolute Pro™ Peripheral Self-Expanding Stent System	The Absolute Pro™ Peripheral Self-Expanding Stent System includes two versions of the device, the Absolute Pro™ and Absolute Pro™ Long Lesion (LL) Peripheral Self-Expanding Stent Systems, which are analyzed together per protocol pre-specification.	None	None	91	151	88	151	View

Serious Events(If Any):

Serious Events

Term	Type	Organ System	Vocab	View

Bleeding	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	Abbott Categories	View
Pain at insertion site	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	Abbott Categories	View
Pseudoaneurysm	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	Abbott Categories	View
Anemia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	Abbott Categories	View
Thrombocytopenia	SYSTEMATIC_ASSESSMENT	Blood and lymphatic system disorders	Abbott Categories	View
Cancer	SYSTEMATIC_ASSESSMENT	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	Abbott Categories	View
Angina	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Arrhythmias (other than bradycardia)	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Bradycardia	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Congestive Heart Failure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Syncope	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Abdominal Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Bleeding	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Diarrhea	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Gastrointestinal Bleed	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Gastro-intestinal	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Other: Cholecystitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Other: Esophagitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Other: Hernia	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Other: Malnutrition	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Other: Pancreatitis	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Pain	SYSTEMATIC_ASSESSMENT	Gastrointestinal disorders	Abbott Categories	View
Fever	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Gastro-intestinal	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Musculoskeletal	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Facial Abscess	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Foot Ulcer	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Inguinal Cellulitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Osteomyelitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Other: Pancreatitis	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Sepsis	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Urinary Tract Infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Viral, bacterial and fungal infections	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Wound complication or wound infection	SYSTEMATIC_ASSESSMENT	Infections and infestations	Abbott Categories	View
Diabetes	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	Abbott Categories	View
Other: Hyperglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	Abbott Categories	View
Other: Hypoglycemia	SYSTEMATIC_ASSESSMENT	Metabolism and nutrition disorders	Abbott Categories	View
Genito-urinary	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Headache	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Musculoskeletal	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Other: Non Cardiac Chest Pain	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Surgery/Interventional Procedure	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Wound complication or wound infection	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Myocardial Infarction - Non-Q- wave	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Myocardial Infarction - Unknown	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Other: Non Stemi MI	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Confusion	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Mental Status Change	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Myalgia	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Hydrocephalus	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Anoxic Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Anxiety	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Extremity Tremors	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Metabolic Encephalopathy	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Other: Subarachnoid/Intracerebral Hemorrhage	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Seizure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Surgery/Interventional Procedure	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Transient Ischemic Attack	SYSTEMATIC_ASSESSMENT	Nervous system disorders	Abbott Categories	View
Dissection	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	Abbott Categories	View
Hypertension	SYSTEMATIC_ASSESSMENT	Injury, poisoning and procedural complications	Abbott Categories	View
Chronic Obstructive Pulmonary Disease	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Other: Pleural Effusion	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Renal Failure	SYSTEMATIC_ASSESSMENT	Renal and urinary disorders	Abbott Categories	View
Other: Drug Toxicity	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Other: Dyspnea	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Other: Shortness Of Breath	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Pneumonia	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Respiratory Failure	SYSTEMATIC_ASSESSMENT	Respiratory, thoracic and mediastinal disorders	Abbott Categories	View
Other: cerebrovascular accident	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Other: Right Cerebellar Infarct	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Stroke: Unknown	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Aneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Dissection	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Hematoma	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Ischemia	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Occlusion	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Other: Carotid Stenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Other: Deep Vein Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Other: Peripheral Vascular Disease	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Pseudoaneurysm	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Restenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Stenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Surgery/Interventional Procedure	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Thrombosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Other: Chest Pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Other: Coronary Artery Disease	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Pain	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Surgery/Interventional Procedure	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Cardiac Arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Hypertension	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Hypotension	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Cardiac Arrest	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View

Other Events(If Any):

Other Events

Term	Type	Organ System	Vocab	View

Arrhythmias (other than bradycardia)	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Hypotension	SYSTEMATIC_ASSESSMENT	Cardiac disorders	Abbott Categories	View
Edema (non pulmonary)	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Musculoskeletal	SYSTEMATIC_ASSESSMENT	Musculoskeletal and connective tissue disorders	Abbott Categories	View
Pain	SYSTEMATIC_ASSESSMENT	General disorders	Abbott Categories	View
Other: Peripheral Vascular Disease	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View
Stenosis	SYSTEMATIC_ASSESSMENT	Vascular disorders	Abbott Categories	View