Myelodysplastic Syndrome Clinical Trial
Official title:
VIDAZA® Drug Use Examination
The main purpose of VIDAZA® DUE (Drug Use Examination) is to collect and evaluate the safety
information of Korean MDS patients treated with VIDAZA®(SC or IV) according to the approved
package insert, after approval of marketing authorization for new drug in Korea. In addition,
the efficacy information of VIDAZA® in clinical practice is collected and evaluated. This DUE
is a prospective, multi-centre, observational, non-interventional, post-marketing
surveillance. At least 600 patients' data that is eligible for safety assessment will be
collected.
VIDAZA® DUE is to investigate frequency and change of Adverse Events(AEs)
/Adverse Drug Reactions(ADRs), Serious Adverse Events(SAEs)/Serious Adverse Drug
Reactions(SADRs), unexpected AE/ADR and unexpected SAE/SADR, and to scrutinize factors
influencing safety & efficacy of the drug. It is necessary to examine patients' demographics
and baseline characteristics, medical history, status of VIDAZA treatment, concomitant
medication and evaluation of safety and final efficacy (best response) assessment.
n/a
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