Bavencio Intravenous 200 mg Special Drug Use results Survey (Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma)
Not Applicable
- Conditions
- Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma
- Registration Number
- JPRN-UMIN000043435
- Lead Sponsor
- Merck Biopharma Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 465
Inclusion Criteria
Not provided
Exclusion Criteria
None
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The safety profile of Bavencio Intravenous 200 mg in clinical practice is to be further characterized, by estimating the incidence of events listed as safety specifications, Urinary tract infection and Hematuria in this surveillance study.
- Secondary Outcome Measures
Name Time Method To investigate the effectiveness of Bavencio Intravenous 200 mg in patients with Maintenance following chemotherapy treatment in curatively unresectable urothelial carcinoma in terms of time to treatment failure(TTF), time to first subsequent therapy (TFST) and overall survival (OS) in clinical practice.