Subject : To understand the usage and performance of Enzyl in real-life clinical practice
Enzalutamide is an androgen receptor inhibitor that is used for the treatment prostate cancer. In a randomized, double-blind, placebo-controlled, multinational, phase III trial in patients with mCRPC progressing after docetaxel therapy, enzalutamide significantly prolonged overall survival (OS), delayed prostate specific antigen progression and prolonged radiographic progression-free survival and time to the first skeletal event. The median OS was 18.4 months in the enzalutamide group and 13.6 months in the placebo group, which represents a 37 % reduction in the mortality risk in the enzalutamide group.
Enzalutamide was also associated with significant benefits in health-related quality of life and in pain palliation. Enzalutamide was generally as well tolerated as placebo during the trial, with most adverse events at a mild or moderate level of severity. Enzalutamide carries a small increased risk of seizures that appears to be dose-dependent. Enzalutamide is an efficacious and well tolerated treatment for this severe, rapidly progressive disease.
Enzalutamide 80 mg capsule & 160 mg tablet is marketed by the Amphion team of Sun Pharma The recommended dose is 160 mg of enzalutamide as a single oral daily dose.
Post marketing of a product, it is important to know how it performs in day-to-day practice of individual medical practitioners. For this purpose, we have planned to conduct a surveillance to assess the in-practice usage and performance of ‘Enzyl’ in real-life clinical practice.
We invite you to participate in this surveillance and share your experience of 10 patients in your routine clinical practice. Thus, this is not an experimental study because data of patients already receiving the product will be captured.
If you agree to participate, we request you to provide us a copy of relevant information from the patient’s case papers, and investigational reports if any (which we call source documents), in the standard data collection forms (which we call DCF). You will be responsible for seeking patient consent and for verifying the DCF with the source documents to ensure that the DCF signed by you are free from errors or omissions. The DCF will not contain the patient’s names so as to ensure confidentiality.
We trust you and we are partners in ensuring safe and effective drug therapy. In that spirit we hope you will consent to participate in this surveillance
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