Regulatory Post Marketing Surveillance Study on Nexavar®
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|ClinicalTrials.gov Identifier: NCT01012011|
Recruitment Status : Completed
First Posted : November 11, 2009
Last Update Posted : September 21, 2015
|Condition or disease||Intervention/treatment|
|Carcinoma, Hepatocellular Carcinoma, Renal Cell||Drug: Sorafenib (Nexavar, BAY43-9006)|
The objectives of this surveillance are to identify problems/questions regarding the followings in the clinical practice of using Nexavar®.
- Unknown adverse events (in particular, serious adverse events)
- Identification of adverse events occurred in the real practice.
- Factors that are considered to affect on safety.
- Factors that are considered to affect on effectiveness
|Study Type :||Observational|
|Actual Enrollment :||2845 participants|
|Official Title:||Regulatory Post Marketing Surveillance Study on Nexavar®|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||August 2015|
Drug: Sorafenib (Nexavar, BAY43-9006)
Daily dose, dosage frequency and duration will be decided by physicians.
- Adverse events collection [ Time Frame: From start of treatment to 4 weeks after discontinuation of treatment ]
- Duration of treatment, dosage and indication [ Time Frame: Whole treatment period ]
- Tumor status [ Time Frame: Whole treatment period ]
- Performance status [ Time Frame: Whole treatment period ]
Biospecimen Retention: None Retained
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01012011
|Korea, Republic of|
|Many Locations, Korea, Republic of|
|Study Director:||Bayer Study Director||Bayer|