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 @ 2:45 PM
Ignite Modification Date: 2025-12-25 @ 1:14 PM
NCT ID: NCT01628159
Description: All Serious Adverse Events (SAE) presented in table were CEC-Adjudicated as probably or highly probably device-related. All non-serious Adverse Events (AE) presented in AE table are site reported and not all may be device-related events. The number of participants affected by non-serious events (528 out of 657 participants) is for all AEs reported in study, not only for events over the 5% threshold.
Frequency Threshold: 5
Time Frame: From Post Index Procedure to End of Follow up Period (5-Year visit window).
Study: NCT01628159
Study Brief: LEVANT 2 Continuation Registry of the Lutonix® Drug Coated Balloon (DCB)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lutonix Drug Coated Balloon Formerly called the Moxy Drug Coated Balloon, the Lutonix Drug Coated Balloon (Lutonix DCB) is a paclitaxel coated balloon catheter Lutonix Drug Coated Balloon: balloon angioplasty with a drug coated balloon 83 None 67 657 528 657 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Infection, local SYSTEMATIC_ASSESSMENT Infections and infestations Internal System View
Infection (systemic) SYSTEMATIC_ASSESSMENT Infections and infestations Internal System View
Significant hemorrhage SYSTEMATIC_ASSESSMENT General disorders Internal System View
Pseudoaneurysm SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Target vessel injury SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Distal embolization with study treatment SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Distal embolization with post treatment SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Clot/Thrombus formation SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Other angiographic event SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Restenosis of study lesion SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Clinically-driven Target Lesion Revascularization SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Target (study) vessel revascularization (TVR) SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Target (study) limb ishchemia SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Other vascular event SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Claudication SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Arrhytmia SYSTEMATIC_ASSESSMENT Cardiac disorders Internal System View
Hypertension SYSTEMATIC_ASSESSMENT Cardiac disorders Internal System View
Other cardiovascular events SYSTEMATIC_ASSESSMENT Cardiac disorders Internal System View
Gastrointestinal events (other) SYSTEMATIC_ASSESSMENT Gastrointestinal disorders Internal System View
Local Infection SYSTEMATIC_ASSESSMENT Infections and infestations Internal System View
Neurological events (other) SYSTEMATIC_ASSESSMENT Nervous system disorders Internal System View
Respiratory (other) SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders Internal System View
Back pain SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Internal System View
Claudication SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Internal System View
Skeletal, spine and muscular events (Other) SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders Internal System View
Restenosis SYSTEMATIC_ASSESSMENT Vascular disorders Internal System View
Renal failure/ insufficiency SYSTEMATIC_ASSESSMENT Renal and urinary disorders Internal System View
Urinary infection SYSTEMATIC_ASSESSMENT Renal and urinary disorders Internal System View
Various SYSTEMATIC_ASSESSMENT General disorders Internal System View
Vessel specific events (Other) SYSTEMATIC_ASSESSMENT General disorders Internal System View