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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01012011
Other study ID # 14792
Secondary ID NX0910KR
Status Completed
Phase N/A
First received November 10, 2009
Last updated September 18, 2015
Start date September 2009
Est. completion date August 2015

Study information

Verified date September 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial 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


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


Recruitment information / eligibility

Status Completed
Enrollment 2845
Est. completion date August 2015
Est. primary completion date January 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 91 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Drug:
Sorafenib (Nexavar, BAY43-9006)
Daily dose, dosage frequency and duration will be decided by physicians.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Adverse events collection From start of treatment to 4 weeks after discontinuation of treatment Yes
Secondary Duration of treatment, dosage and indication Whole treatment period No
Secondary Tumor status Whole treatment period No
Secondary Performance status Whole treatment period No
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