Regulatory Post Marketing Surveillance Study on Nexavar®

September 18, 2015 updated by: Bayer
This surveillance are to identify problems/questions regarding adverse events, factors that are considered to affect on safety and efficacy in the clinical practice of using Nexavar

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.

  1. Unknown adverse events (in particular, serious adverse events)
  2. Identification of adverse events occurred in the real practice.
  3. Factors that are considered to affect on safety.
  4. Factors that are considered to affect on effectiveness

Study Type

Observational

Enrollment (Actual)

2845

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 91 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with diagnosis of advanced renal cell carcinoma or hepatocellular carcinoma and decision taken by the physician to precribe Nexavar

Description

Inclusion Criteria:

  • Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.

Exclusion Criteria:

  • Exclusion criteria must be read in conjunction with the local product information but patients who are participating in other interventional studies currently will be excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Sorafenib (Nexavar, BAY43-9006)
Daily dose, dosage frequency and duration will be decided by physicians.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adverse events collection
Time Frame: From start of treatment to 4 weeks after discontinuation of treatment
From start of treatment to 4 weeks after discontinuation of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration of treatment, dosage and indication
Time Frame: Whole treatment period
Whole treatment period
Tumor status
Time Frame: Whole treatment period
Whole treatment period
Performance status
Time Frame: Whole treatment period
Whole treatment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

November 10, 2009

First Submitted That Met QC Criteria

November 10, 2009

First Posted (Estimate)

November 11, 2009

Study Record Updates

Last Update Posted (Estimate)

September 21, 2015

Last Update Submitted That Met QC Criteria

September 18, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14792
  • NX0910KR (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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