Leukemia, Myeloid, Acute, Leukemia, Myelomonocytic, Chronic, Myelodysplastic Syndromes
Conditions
Keywords
Myelodysplastic syndromes (MDS), Azacitidine (AZA), Chronic myelomonocytic leukemia (CMML), Acute myeloid leukemia (AML)
Brief summary
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.
Detailed description
This study will have participants both enrolled retrospectively and prospectively for azacitidine (AZA) treatment.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Events (AEs) | Up to 12 Months |
| Incidence of Serious Adverse Events (SAEs) | Up to 12 Months |
| Incidence of Adverse Drug Reactions (ADRs) | Up to 12 Months |
Secondary
| Measure | Time frame |
|---|---|
| Best Overall response rate (ORR) defined as the proportion of participants who achieved best response of superior to stable disease | Up to 12 Months |
Countries
China
Outcome results
None listed