Stivarga Real Life Evidence in Hungary

Bayer

Status: Completed

Conditions: Colorectal Neoplasms

Treatments: Drug: Regorafenib (Stivarga, BAY73-4506)

Study type: Observational

Funder types: Industry

Identifiers

NCT02656524

18686

Details and patient eligibility

About

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.

Enrollment: 400 patients

Sex: All

Volunteers: No Healthy Volunteers

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).

Exclusion criteria

• Not applicable

Trial design

400 participants in 1 patient group

Cohort1/Regorafenib

Description:

All patients with at least 1 treatment with regorafenib

Treatment:

Drug: Regorafenib (Stivarga, BAY73-4506)