A Study of Azacitidine in Participants With International Prognostic Scoring System (IPSS) Intermediate-2 and High-risk Myelodysplastic Syndromes (MDS), or Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML)

Bristol-Myers Squibb290 enrolled

Overview

The purpose of this study is to assess the safety and effectiveness in the real-world setting among participants who are treated with Azacitidine in accordance with the China Product Label.

This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.

Study Type

OBSERVATIONAL

Enrollment

290

Conditions

Myelodysplastic Syndromes Leukemia, Myelomonocytic, Chronic Leukemia, Myeloid, Acute

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Documented diagnosis of intermediate-2/ high-risk myelodysplastic syndromes (MDS) or chronic myelomonocytic leukemia (CMML) or acute myeloid leukemia (AML) with 20-30% bone marrow blasts and multi-lineage dysplasia * Initiated azacitidine (AZA) treatment per approved China Product Label after April 2017 Exclusion Criteria: * Contraindicated for the use of AZA according to China Product Label * Simultaneously participating in a treatment intervention study Other protocol-defined inclusion/exclusion criteria apply.

Locations (1)

Outcomes

Primary Outcomes

Incidence of Adverse Events (AEs)

Time frame: Up to 12 Months

Incidence of Serious Adverse Events (SAEs)

Time frame: Up to 12 Months

Incidence of Adverse Drug Reactions (ADRs)

Time frame: Up to 12 Months

Secondary Outcomes

Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease

Time frame: Up to 12 Months