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 @ 3:45 AM
Ignite Modification Date: 2025-12-26 @ 2:31 AM
NCT ID: NCT01537302
Description: None
Frequency Threshold: 0
Time Frame: Day 0 through Day 30
Study: NCT01537302
Study Brief: Chronic Total Occlusion Crossing With the Ocelot System - CONNECT II
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Ocelot System CTO crossing in femoropopliteal arteries using the Ocelot System 0 None 26 100 25 100 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
AV Fistula SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Vessel Dissection, Grade A or B SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Bruising or hemorrhage at procedural access site SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain, new or worsening SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding (other than access site) SYSTEMATIC_ASSESSMENT Vascular disorders None View
Hypotension, sustained SYSTEMATIC_ASSESSMENT Vascular disorders None View
Perforation requiring intervention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Shortness of breath SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Urinary tract infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Perforation, not requiring intervention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Acute COPD exacerbation SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Aneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Allergic reaction to contrast medium SYSTEMATIC_ASSESSMENT Immune system disorders None View
Lethargy SYSTEMATIC_ASSESSMENT General disorders None View
Uncontrolled hyperglycemia SYSTEMATIC_ASSESSMENT Metabolism and nutrition disorders None View
Vessel Dissection, Grade C or greater SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
limb ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
Embolism SYSTEMATIC_ASSESSMENT Vascular disorders None View
Altered mental state SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Leg ulcerations SYSTEMATIC_ASSESSMENT Vascular disorders None View
Depression SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Intractable nausea/vomiting SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Bruising or hemorrhage at procedural access site SYSTEMATIC_ASSESSMENT Vascular disorders None View
Swelling SYSTEMATIC_ASSESSMENT Vascular disorders None View
Confusion SYSTEMATIC_ASSESSMENT Psychiatric disorders None View
Nausea/Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Perforation not requiring intervention SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel dissection, Grade C or greater SYSTEMATIC_ASSESSMENT Vascular disorders None View
AV fistula SYSTEMATIC_ASSESSMENT Vascular disorders None View
Bleeding, other than access site SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dysphagia SYSTEMATIC_ASSESSMENT Nervous system disorders None View
Pain, new or worsening SYSTEMATIC_ASSESSMENT General disorders None View
Vessel dissection, Grade A or B SYSTEMATIC_ASSESSMENT Vascular disorders None View
Shortness of breath SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View