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 @ 11:57 PM
Ignite Modification Date: 2025-12-25 @ 9:54 PM
NCT ID: NCT01937351
Description: There were three types of events in the study. Major Adverse Event (MAE), Serious Adverse Event (SAE), Adverse Event (AE). Collection of event data was reported by the site within 24 hours for MAEs, 10 days for SAEs and collected during routine monitoring visits for all other AEs.
Frequency Threshold: 5
Time Frame: All subjects between enrollment and 6 month follow-up.
Study: NCT01937351
Study Brief: Evaluation of the Pantheris Atherectomy System
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Primary Cohort Pantheris System 5 None 89 134 22 22 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Clinically Driven Target Lesion Revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Myocardial Infarction SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Clinically Driven Target Vessel Revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stenosis Contralateral (Right) Leg SYSTEMATIC_ASSESSMENT Vascular disorders None View
Stenosis of Left Common Fem Artery Following Procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
TIA Before Admission SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Ulcer Right Heel SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Unplanned, Nontarget Limb Intervention SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Urinary Retension SYSTEMATIC_ASSESSMENT General disorders None View
Urinary Tract Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Vomiting SYSTEMATIC_ASSESSMENT General disorders None View
Access Site Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Bleeding (other than access site) SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypotension, sustained SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Loss of distal collateral flow SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain, new onset or worsening from baseline SYSTEMATIC_ASSESSMENT Vascular disorders None View
Perforation, NHLBI Type I or II SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Emboli requiring intervention to resolve acutely SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel dissection, Grade C or greater SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pseudoaneurysm defined as device related disruption of the arterial wall SYSTEMATIC_ASSESSMENT Vascular disorders None View
Vessel dissection, Grade A or B SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Thrombosis SYSTEMATIC_ASSESSMENT Vascular disorders None View
Unplanned Limb Amputation (Minor or Non-Target Limb) SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other, Acute Bronchitis SYSTEMATIC_ASSESSMENT General disorders None View
Acute Bronchitis SYSTEMATIC_ASSESSMENT General disorders None View
Acute Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute on Chronic Anemia SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Acute on Chronic Kidney Injury SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Acute on Chronic Systolic Congestive Heart Failure Exacerbation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Acute Renal Failure (CR 1.06) SYSTEMATIC_ASSESSMENT Renal and urinary disorders None View
Altered Mental Status Due to Hypoglycemia SYSTEMATIC_ASSESSMENT General disorders None View
Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Atypical Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Bradycardia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
BTK PAD RLE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Burn to Left Heel SYSTEMATIC_ASSESSMENT Skin and subcutaneous tissue disorders None View
Chest Pain SYSTEMATIC_ASSESSMENT General disorders None View
Chest Pain Syndrome of Unknown Etiology SYSTEMATIC_ASSESSMENT General disorders None View
Congestive Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Community Acquired RUL Pneumonia SYSTEMATIC_ASSESSMENT General disorders None View
Degenerative Joint Disease SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Diastolic Heart Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Difficulty Swallowing SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea SYSTEMATIC_ASSESSMENT General disorders None View
Dyspnea on Extertion SYSTEMATIC_ASSESSMENT General disorders None View
Episodic Atrial Fibrillation SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Gangrenous Changes to Bilateral Metatarsals SYSTEMATIC_ASSESSMENT Infections and infestations None View
Head Trauma S/P Substantial Fall SYSTEMATIC_ASSESSMENT Injury, poisoning and procedural complications None View
Hypertensive Crisis SYSTEMATIC_ASSESSMENT General disorders None View
Hypoglycemia SYSTEMATIC_ASSESSMENT General disorders None View
Hypokalemia SYSTEMATIC_ASSESSMENT General disorders None View
Intermittent Chest Discomfort SYSTEMATIC_ASSESSMENT General disorders None View
Intervention Of Contralateral Leg SYSTEMATIC_ASSESSMENT Vascular disorders None View
Left Patella Fracture SYSTEMATIC_ASSESSMENT Musculoskeletal and connective tissue disorders None View
Mild Leukocytosis SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Multi-organ Failure SYSTEMATIC_ASSESSMENT General disorders None View
Nausea SYSTEMATIC_ASSESSMENT General disorders None View
Non Target Revascularization SYSTEMATIC_ASSESSMENT Vascular disorders None View
NSTEMI SYSTEMATIC_ASSESSMENT Cardiac disorders None View
PAD-LSFA SYSTEMATIC_ASSESSMENT Vascular disorders None View
Pain - Right Upper Chest SYSTEMATIC_ASSESSMENT General disorders None View
Pneumonia SYSTEMATIC_ASSESSMENT Infections and infestations None View
Poor Healing Bilateral TMA Wounds Including Infection and Dehiscence SYSTEMATIC_ASSESSMENT Infections and infestations None View
Pseudoaneurysm at Non-Index Procedure SYSTEMATIC_ASSESSMENT Vascular disorders None View
Reperfusion Edema SYSTEMATIC_ASSESSMENT Vascular disorders None View
Respiratory Failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Right Anterior Tibia Hematoma SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Right Leg Ischemia SYSTEMATIC_ASSESSMENT Vascular disorders None View
RLE Abscess on Shin SYSTEMATIC_ASSESSMENT Infections and infestations None View
Septic Schock SYSTEMATIC_ASSESSMENT Infections and infestations None View
Shortness of Breath Due to Influenza A SYSTEMATIC_ASSESSMENT General disorders None View
Other, Abrasion/Cellutitis (R) UE SYSTEMATIC_ASSESSMENT Vascular disorders None View
Other Events(If Any):

Other Events

Term Type Organ System Vocab View
Pain, New Onset or Worsening from Baseline SYSTEMATIC_ASSESSMENT General disorders None View
Access Site Complication SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View