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 @ 2:24 AM
Ignite Modification Date: 2025-12-26 @ 12:56 AM
NCT ID: NCT02730234
Description: Definition are consistent with clinicaltrials.gov definition for AE and SAE
Frequency Threshold: 5
Time Frame: Major Adverse Events were collected for up to 1 year
Study: NCT02730234
Study Brief: JetStream Atherectomy for the Treatment of In-stent Restenosis
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
JetStream XC With Balloon Angioplasty The intervention consists of JetStream atherectomy of femoropopliteal in-stent restenosis using the JetStream XC device followed by adjunctive balloon angioplasty in all patients. JetStream XC with balloon angioplasty: JetStream XC to treat femoropopliteal in-stent restenosis followed by adjunctive balloon angioplasty (same arm). The control arm in this study is historic. 8 None 21 60 15 60 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Target Lesion Revascularization with Bailout Stenting NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Target Lesion Revascularization without Bailout Stenting NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Unplanned Major amputation NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
New Stent Fracture or Disruption NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Device Induced Vascular Injury NON_SYSTEMATIC_ASSESSMENT Vascular disorders None View
Distal Embolization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Major Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Nonfatal myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Angina SYSTEMATIC_ASSESSMENT Cardiac disorders None View
worsening claudication in non affected limb SYSTEMATIC_ASSESSMENT Vascular disorders None View