Study 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

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.

Trial summary

Enrollment Goal

2845

Trial Dates

September 2009 - August 2015

Phase

N/A

Could I Receive a placebo

Products

Nexavar (Sorafenib, BAY43-9006)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed		Many Locations, Korea, Republic Of

Primary Outcome

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

Secondary Outcome

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