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A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

Last updated on March 14, 2019

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Study Location
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Cell Carcinoma
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- Subjects that will be included in this post marketing surveillance study must be
consistent with the approved label indication of Torisel in the Philippines.

- As per approved label indication, patients diagnosed with advanced renal cell
carcinoma will be the ones eligible to participate in the study.

- The decision to prescribe Torisel will necessarily precede and will be independent of
the decision to enroll the patient into the study.

- Evidence of a personally signed and dated informed consent document indicating that
the subject (or a legally acceptable representative) has been informed of all
pertinent aspects of the study.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Subjects with conditions that are contraindicated with Torisel based on the approved
local product document in the Philippines will be excluded in this study. This
condition includes: Patients with bilirubin >1.5 x ULN.

NCT01781442
Pfizer
Withdrawn
A Post Marketing Surveillance As Required By Philippine Food And Drug Administration

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