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Regulatory Post Marketing Surveillance Study on Nexavar®

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ClinicalTrials.gov Identifier: NCT01012011
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : September 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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

Condition or disease Intervention/treatment
Carcinoma, Hepatocellular Carcinoma, Renal Cell Drug: Sorafenib (Nexavar, BAY43-9006)

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 Design
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Study Type : Observational
Actual Enrollment : 2845 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Regulatory Post Marketing Surveillance Study on Nexavar®
Study Start Date : September 2009
Actual Primary Completion Date : January 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine


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


Outcome Measures
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Primary Outcome Measures :
  1. Adverse events collection [ Time Frame: From start of treatment to 4 weeks after discontinuation of treatment ]

Secondary Outcome Measures :
  1. Duration of treatment, dosage and indication [ Time Frame: Whole treatment period ]
  2. Tumor status [ Time Frame: Whole treatment period ]
  3. Performance status [ Time Frame: Whole treatment period ]

Biospecimen Retention:   None Retained
n.a

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 91 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012011


Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information
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Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01012011     History of Changes
Other Study ID Numbers: 14792
NX0910KR ( Other Identifier: company internal )
First Posted: November 11, 2009    Key Record Dates
Last Update Posted: September 21, 2015
Last Verified: September 2015

Keywords provided by Bayer:
Carcinoma, Hepatocellular
Carcinoma, Renal Cell

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
 Liver Diseases
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action