Acute Myeloid Leukemia
Conditions
Brief summary
The purpose of this observational study is to assess the real-world safety of maintenance therapy with oral azacitidine in Korean participants with acute myeloid leukemia (AML) who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following induction chemotherapy with or without consolidation therapy, and who are not eligible for hematopoietic stem cell transplantation (HSCT).
Interventions
DRUGOral azacitidine
Maintenance therapy according to the approved label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult participants 19 years of age or older * Participants who receive oral azacitidine according to the approved label * For the first 2 years after marketing authorization, all participants who have received or are receiving oral azacitidine will also be registered * Participants who sign the informed consent form
Exclusion criteria
* Participants who are prescribed oral azacitidine for therapeutic indications not approved in Korea * Participants for whom oral azacitidine is contraindicated per the Korean prescribing information approved by ministry of food and drug safety
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with adverse events (AES) | Up to 12 months | The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine |
Countries
South Korea
Contacts
Primary ContactBMS Study Connect Contact Center www.BMSStudyConnect.com
Backup ContactFirst line of the email MUST contain NCT # and Site #.
Outcome results
None listed