Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03232593
NCT03232593CompletedNot Applicable

Post-Marketing Surveillance of Tecentriq in MFDS-Approved Indication(s)

Hoffmann-La Roche55 sites in 1 country1,758 target enrollmentStarted: November 29, 2017Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
1,758
Locations
55
Primary Endpoint
Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Participants who Receive Atezolizumab

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.

Intervention: Atezolizumab (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs)

Time Frame: Approximately 6 years

Secondary Outcomes

  • Percentage of Participants With Progressive Disease (PD) Assessed per RECIST 1.1(Approximately 6 years)
  • Percentage of Participants With Complete Response (CR) Assessed per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)(Approximately 6 years)
  • Percentage of Participants With Stable Disease (SD) Assessed per RECIST 1.1(Approximately 6 years)
  • Percentage of Participants With Partial Response (PR) Assessed per RECIST 1.1(Approximately 6 years)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (55)

Loading locations...

Similar Trials

Completed
Phase 4
Post-Market Surveillance Study of the TM Ardis Interbody Fusion SystemDegenerative Disc Disease
NCT02429908Zimmer Biomet80
Completed
Not Applicable
An Observational Study of Herceptin SC Safety in Breast CancerBreast Cancer
NCT02305628Hoffmann-La Roche600
Recruiting
Phase 4
A Post Marketing Surveillance to Evaluate the Safety of Desidustat for the Treatment of Anemia in Subjects With Chronic Kidney Disease (CKD).(Real World Evidence Study)Chronic Kidney DiseasesAnemia of Chronic Kidney Disease
NCT05515367Zydus Lifesciences Limited1,004
Terminated
Not Applicable
PMCF Study of the CLS Brevius Stem With Kinectiv TechnologyFemoral Neck FracturesProsthesis FailureOsteoarthritisRheumatoid ArthritisAvascular Necrosis
NCT03410940Zimmer Biomet223
Completed
Not Applicable
Observational Study of Pertuzumab Safety in Participants With Breast CancerBreast Cancer
NCT02266173Hoffmann-La Roche1,130