Brief Title
A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)
Official Title
Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)
Brief Summary
This Phase 4, prospective, multicenter, non-interventional, regulatory post-marketing surveillance study will collect information on the the safety and effectiveness of atezolizumab under the clinical practice, and update the drug label approved by the MFDS in Korea.
Study Type
Observational
Primary Outcome
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Secondary Outcome
Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Condition
Urothelial Carcinoma
Intervention
Atezolizumab
Study Arms / Comparison Groups
Participants who Receive Atezolizumab
Description: Participants who are administered with atezolizumab as per the local label and standard of care at physician's discretion will be observed for approximately 6 years.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
1758
Start Date
November 29, 2017
Completion Date
August 12, 2022
Primary Completion Date
August 12, 2022
Eligibility Criteria
Inclusion Criteria: - Participants who are administered with atezolizumab for the locally approved indications Exclusion Criteria: - Participants with a known hypersensitivity to atezolizumab or to any of the excipients
Gender
All
Ages
N/A - N/A
Accepts Healthy Volunteers
No
Contacts
Clinical Trials, ,
Location Countries
Korea, Republic of
Location Countries
Korea, Republic of
Administrative Informations
NCT ID
NCT03232593
Organization ID
ML39313
Responsible Party
Sponsor
Study Sponsor
Hoffmann-La Roche
Study Sponsor
Clinical Trials, Study Director, Hoffmann-La Roche
Verification Date
August 2022