Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea
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Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Korea who has a disease for which Axitinib is indicated
Patients diagnosed as advanced renal cell carcinoma (aRCC) after failure of one prior systemic therapy.
Patients to whom INLYTA® is first administered or patients who are already on INLYTA® during the study period
Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information
Patients with hypersensitivity to axitinib or to any other component of INLYTA®
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Keywords provided by Pfizer:
Korean PMS of Axitinib
Metastatic RCC ; 2nd line only
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms by Site