The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients treated with Imfinzi under the approved indication in Korea.
Primary objective : To assess safety of Imfinzi for patients treated with Imfinzi under the approved indication in Korea Outcome Measure: * Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE)) * Dose interruptions * Duration of treatment * Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients treated with Imfinzi under the approved indication in Korea Outcome Measure: * Progression free survival (PFS) * Objective response rate (ORR) * Duration of response (DoR)
Study Type
OBSERVATIONAL
Enrollment
712
Research Site
Anyang-si, South Korea, South Korea
Research Site
Bucheon-si, South Korea, South Korea
Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE)
safety outcome
Time frame: for up to 1 year after the first dose of Imfinzi
Dose interruptions
Safety outcome
Time frame: for up to 1 year after the first dose of Imfinzi
Duration of treatment
Safety outcome
Time frame: for up to 1 year after the first dose of Imfinzi
Progression free survival (PFS)
efficacy outcome
Time frame: for up to 1 year after the first dose of Imfinzi
Objective response rate (ORR)
efficacy outcome
Time frame: for up to 1 year after the first dose of Imfinzi
Duration of response (DoR)
efficacy outcome
Time frame: for up to 1 year after the first dose of Imfinzi
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Research Site
Busan, South Korea, South Korea
Research Site
Changwon, South Korea, South Korea
Research Site
Changwon-si, South Korea, South Korea
Research Site
Cheonan, South Korea, South Korea
Research Site
Chuncheon, South Korea, South Korea
Research Site
Daegu, South Korea, South Korea
Research Site
Daejeon, South Korea, South Korea
Research Site
Goyang-si, South Korea, South Korea
...and 14 more locations