A Study of Atezolizumab (Tecentriq®) in Ministry of Food and Drug Safety (MFDS)-Approved Indication(s)

Sponsor
Hoffmann-La Roche
Study ID
NCT03232593
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Atezolizumab — DRUG
    Participants will receive atezolizumab as per the local label and standard of care at physician's discretion.

Study Details

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.

Key Dates

Start date
Nov 29, 2017
Status verified
Aug 2022
Primary completion
Aug 12, 2022
Completion
Aug 12, 2022

Study Design

Enrollment
1,758 participants (actual)

Arms

  • Arm: 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.

Primary Outcome Measure

Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) [ Time Frame: Approximately 6 years ]

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