Regulatory Post Marketing Surveillance Study on Nexavar®
|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|
|Primary Completion Date :||January 2015|
|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
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|