check_circleStudy Completed

Carcinoma, Hepatocellular, Carcinoma, Renal Cell

Bayer Identifier:

14792

ClinicalTrials.gov Identifier:

NCT01012011

EudraCT Number:

Not Available

EU CT Number:

Not Available
Regulatory Post Marketing Surveillance Study on Nexavar®

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

20 - 91 Years
  • - Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
  • - 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.

Trial summary

Enrollment Goal
2845
Trial Dates
September 2009 - August 2015
Phase
N/A
Could I Receive a placebo
No
Products
Nexavar (Sorafenib, BAY43-9006)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Adverse events collection
    date_rangeTime Frame:
    From start of treatment to 4 weeks after discontinuation of treatment
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Duration of treatment, dosage and indication
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Tumor status
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    No
  • Performance status
    date_rangeTime Frame:
    Whole treatment period
    enhanced_encryption
    Safety Issue:
    No

Trial design

Regulatory Post Marketing Surveillance Study on Nexavar®
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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