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A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Completed
Conditions
Infusion Reaction
Registration Number
NCT01156090
Lead Sponsor
SCRI Development Innovations, LLC
Brief Summary

The purpose of this study is to identify approximately 100 - 150 patients who have received Vectibix (Panitumumab) in offices and clinics located in Tennessee, North Carolina, South Carolina, and North Georgia from February 2004 - April 2009. Information regarding the incidence and severity of hypersensitivity infusion reactions to Vectibix (Panitumumab)will be captured. In patients who experienced hypersensitivity reactions, the following information will also be collected: premedication, treatment cycle symptoms that were experienced during chemotherapy, changes required in subsequent Vectibix (Panitumumab) or chemotherapy treatment, and outcome of the hypersensitivity reaction.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
141
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Rate of Vectibix-related infusion reactions w/high rate of Erbitux-related infusion reactionsFebruary 2004 -April 2009

To determine the rate of Vectibix (Panitumumab)-related infusion reactions (CTCAE v3.0 grade I-IV) in geographic areas of the United States associated with a high rate of Erbitux-related infusion reactions

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (7)

St. Louis Cancer Care

🇺🇸

Chesterfield, Missouri, United States

South Carolina Oncology Associates, PA

🇺🇸

Columbia, South Carolina, United States

Northeast Georgia Medical Center

🇺🇸

Gainesville, Georgia, United States

Medical Oncology Associates of Augusta

🇺🇸

Augusta, Georgia, United States

Baptist Hospital East

🇺🇸

Louisville, Kentucky, United States

Tennessee Oncology, PLLC

🇺🇸

Nashville, Tennessee, United States

Northeast Arkansas Clinic

🇺🇸

Jonesboro, Arkansas, United States

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