A Post-Marketing Surveillance Study to Assess the Safety of Oral Azacitidine Maintenance Therapy in Korean Patients With Acute Myeloid Leukemia

Bristol-Myers Squibb154 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

154

Conditions

Acute Myeloid Leukemia

Interventions

Oral azacitidineDRUG

Maintenance therapy according to the approved label

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of participants with adverse events (AES)

The type, frequency, seriousness and severity of adverse events (AEs), and relationship of AEs to oral azacitidine

Time frame: Up to 12 months

Central Contacts

BMS Study Connect Contact Center www.BMSStudyConnect.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

First line of the email MUST contain NCT # and Site #.