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Regulatory Post Marketing Surveillance Study on Nexavar®

Regulatory Post Marketing Surveillance Study on Nexavar®

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01012011
Enrollment
2845
Registered
2009-11-11
Start date
2009-09-30
Completion date
2015-08-31
Last updated
2015-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carcinoma, Hepatocellular, Carcinoma, Renal Cell

Keywords

Carcinoma, Hepatocellular, Carcinoma, Renal Cell

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

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

Interventions

DRUGSorafenib (Nexavar, BAY43-9006)

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

Sponsors

Bayer
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to 91 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

*

Design outcomes

Primary

MeasureTime frame
Adverse events collectionFrom start of treatment to 4 weeks after discontinuation of treatment

Secondary

MeasureTime frame
Duration of treatment, dosage and indicationWhole treatment period
Tumor statusWhole treatment period
Performance statusWhole treatment period

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026