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 @ 10:35 PM
Ignite Modification Date: 2025-12-25 @ 8:07 PM
NCT ID: NCT00733135
Description: None
Frequency Threshold: 5
Time Frame: Through 30 days post-procedure
Study: NCT00733135
Study Brief: Study of the SilverHawk™ /TurboHawk™ Plaque Excision Systems Used With SpiderFX to Treat Calcified Peripheral Arterial Disease (DEFINITIVE Ca++)
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Study Cohort All participants were treated with SilverHawk/TurboHawk atherectomy catheters, with the SpiderFX Embolic Protection Device placed distally. None None 26 133 36 133 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Access Site AE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Amputation at or below metatarsal line SYSTEMATIC_ASSESSMENT Vascular disorders None View
AV fistula, target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection, grade A or B; target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection, grade D or greater; target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Distal embolism; plaque, thrombus (blood clot) or debris distal to the filter, clinically relevant SYSTEMATIC_ASSESSMENT Vascular disorders None View
GI bleeding due to anticoagulation SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Hypotension or hypertension SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial infarction, acute SYSTEMATIC_ASSESSMENT Vascular disorders None View
Renal insufficiency SYSTEMATIC_ASSESSMENT Endocrine disorders None View
Pseudoaneurysm, non-target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Target vessel revascularization; non-clinically driven SYSTEMATIC_ASSESSMENT Vascular disorders None View
Thrombosis (acute and subacute); target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel clinical perforation, target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other, respiratory SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Other SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Access site adverse event SYSTEMATIC_ASSESSMENT Vascular disorders None View
Dissection, grade A or B; target vessel SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other SYSTEMATIC_ASSESSMENT Vascular disorders None View