Regulatory Post Marketing Surveillance Study on Nexavar®

NCT ID: NCT01012011

Last Updated: 2015-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2845 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-09-30

Study Completion Date

2015-08-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Carcinoma, Hepatocellular Carcinoma, Renal Cell

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Sorafenib (Nexavar, BAY43-9006)

Intervention Type DRUG

Daily dose, dosage frequency and duration will be decided by physicians.

Interventions

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Sorafenib (Nexavar, BAY43-9006)

Daily dose, dosage frequency and duration will be decided by physicians.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients with diagnosis of advanced RCC or HCC and decision taken by the physician to prescribe Nexavar.
Minimum Eligible Age

20 Years

Maximum Eligible Age

91 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bayer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bayer Study Director

Role: STUDY_DIRECTOR

Bayer

Locations

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Many Locations, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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NX0910KR

Identifier Type: OTHER

Identifier Source: secondary_id

14792

Identifier Type: -

Identifier Source: org_study_id

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