Based on the re-review of new drugs article, Korean pharmaceutical act, the objectives of this study are to assess safety and effectiveness of the study drugs(Imjudo \& Imfinzi) in a real world setting in patients who treated according to the approved indications in Korea.
Primary Objective: To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea Secondary Objective: To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea Exploratory Objective: To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Study Type
OBSERVATIONAL
Enrollment
246
Research Site
Busan, South Korea
RECRUITINGResearch Site
Goyang, South Korea
RECRUITINGResearch Site
Seongnam, South Korea
RECRUITINGSafety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions (ADRs), serious ADRs (SADRs), unexpected AEs/ADRs)
To assess safety of the study drugs for patients treated with the study drugs under the approved indication in Korea
Time frame: For Imjudo will be conducted for 90 days from the first dose of the treatment. For Imfinzi will be separately conducted for 1 year from the first dose.
Objective Response Rate(ORR)
To assess effectiveness of the study drugs for patients treated with the study drugs under the approved indication in Korea
Time frame: For 1 year from the first dose of the treatment
AstraZeneca Clinical Study Information Center
CONTACT
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Research Site
Seoul, South Korea
RECRUITINGResearch Site
Seoul, South Korea
NOT_YET_RECRUITINGResearch Site
Suwon, South Korea
RECRUITING