Status:
COMPLETED
A Retrospective Cohort Study of Infusion Reactions Due to Vectibix
Lead Sponsor:
SCRI Development Innovations, LLC
Collaborating Sponsors:
Amgen
Conditions:
Infusion Reaction
Eligibility:
All Genders
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 Nort...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- All patients treated with at least one treatment of Vectibix(Panitumumab) from February 2004 -April 2009 are eligible for the study. Patients may or may not have had an infusion reaction to Vectibix (Panitumumab). Major infusion reactions are defined as rapid onset airway obstruction(bronchospasm, stridor, hoarseness), urticaria, erythema, and/or hypotension, anaphylaxis. Minor infusion reactions are defined as transient flushing or rash, urticaria, dyspnea, drug fever.
- Patients who have received treatment with an EGFR in the past are eligible.
- Exclusion Criteria
- There will be no exclusions based on age, sex, medical history, or use of concomitant therapies. All charts will be abstracted for the same information, through completion of the last chemotherapy cycle.
Exclusion
Key Trial Info
Start Date :
June 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 1 2013
Estimated Enrollment :
141 Patients enrolled
Trial Details
Trial ID
NCT01156090
Start Date
June 1 2010
End Date
January 1 2013
Last Update
August 28 2015
Active Locations (7)
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1
Northeast Arkansas Clinic
Jonesboro, Arkansas, United States, 72401
2
Medical Oncology Associates of Augusta
Augusta, Georgia, United States, 30901
3
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
4
Baptist Hospital East
Louisville, Kentucky, United States, 40207