Stivarga Real Life Evidence in Hungary

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

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-01

Study Completion Date

2017-02-15

Brief Summary

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The study aims to evaluate use of regorafenib in clinical practice in Hungary. The study should provide information about clinical characteristics of Hungarian regorafenib patients as well as information about safety and efficacy of regorafenib in Hungarian patients with metastatic colorectal cancer. This much needed data is required by the National Health Insurance Fund in order to accept regorafenib into the regular reimbursement system. This study is proposed to be based on patient data from the Hungarian National Health Insurance Fund's Database. Data to be analyzed includes patient demography and baseline tumor characteristics, overall survival, time to treatment failure, duration of treatment, average dose and dose modifications, and adverse events. Further, treatment costs will be estimated.

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Detailed Description

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Conditions

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Colorectal Neoplasms

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Cohort1/Regorafenib

All patients with at least 1 treatment with regorafenib

Regorafenib (Stivarga, BAY73-4506)

Intervention Type DRUG

Product is used in accordance with SmPC

Interventions

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Regorafenib (Stivarga, BAY73-4506)

Product is used in accordance with SmPC

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Using the National Health Insurance Database, patients will be included in this retrospective data analysis if they had at least one dose of regorafenib treatment cycle (=28 days).