The objective of this study is to describe the observed safety profile of Xospata® 40 mg tablet when administered in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea.
This study is being mandated by Ministry of Food and Drug Safety (MFDS) as a part of the Korea-Risk Management Plan (K-RMP) to assess safety in patients with relapsed or refractory AML with FLT3 mutation in routine clinical practice in Korea. This study collects data for 54 months according to the purpose of this study in routine clinical practice as an observational study.
Study Type
OBSERVATIONAL
Enrollment
33
Oral
Site KR82013
Wŏnju, Gangwon-do, South Korea
Site KR82006
Goyang-si, Gyeonggi-do, South Korea
Site KR82003
Jeollanam-do, Hwasun-gun, South Korea
Site KR82011
Busan, South Korea
Number of participants with Adverse Drug Reactions (ADRs) related to important identified and/or potential risks
An Adverse Drug Reaction refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded.
Time frame: Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with serious ADRs related to important identified and/or potential risks
An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to important identified risks such as posterior reversible encephalopathy syndrome (PRES), QT prolongation, differentiation syndrome, and/or important potential risks such as pancreatitis, embryo-fetal lethality, suppressed fetal growth and teratogenicity, will be recorded. An ADR is considered "serious" if, in the view of either the investigator or sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.
Time frame: Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with ADRs related to identified risks and considered not important
An ADR refers to any unfavorable and unintended reaction occurring with a normal administration or use of the medicinal product that a causal relationship to the medicinal product cannot be ruled out. Number of ADRs related to identified risks but considered not important, such as other ADRs described by the Korean package insert, will be recorded. An ADR is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event.
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Site KR82010
Daegu, South Korea
Site KR82001
Incheon, South Korea
Site KR82004
Seoul, South Korea
Site KR82005
Seoul, South Korea
Site KR82009
Seoul, South Korea
Site KR82007
Seoul, South Korea
Time frame: Up to a maximum of 54 months (until 30 days after the last dose)
Number of participants with AEs
An AE is defined as any untoward medical occurrence in a subject administered a study drug, and which does not necessarily have to have a causal relationship with this treatment. An AE is considered "serious" if, in the view of either the investigator or Sponsor, it results in any of the following outcomes: results in death, is life-threatening, results in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, results in congenital anomaly or birth defect, requires inpatient hospitalization or prolongation of hospitalization, or other medically important event. Causal relationship between the study drug is judged by medically qualified investigator either as certain, probable/likely, possible, unlikely, conditional/unclassified or unassessable/unclassifiable.
Time frame: Up to a maximum of 54 months (until 30 days after the last dose)