A Retrospective Cohort Study of Infusion Reactions Due to Vectibix

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

141 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2013-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Infusion Reaction

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Vectibix

patients who received at least one treatment of Vectibix

No interventions assigned to this group

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No