The purpose of this study is to understand real-world effectiveness of luspatercept treatment among erythropoiesis-stimulating agents -naïve patients with lower-risk- myelodysplastic syndromes in the United States
Study Type
OBSERVATIONAL
Enrollment
418
As per product lable
As per product label
RTI Health Solutions
Raleigh, North Carolina, United States
Participant baseline demographics
Time frame: Baseline
Participant baseline clinical characteristics
Time frame: Baseline
Time from Lower Risk- myelodysplastic syndromes diagnosis to index treatment initiation
Time frame: Baseline
Rationale for therapy selection
Time frame: Baseline
Duration of index treatment
Time frame: Up to 15 months
Treatment dose at treatment initiation and discontinuation
Time frame: Up to 6 months
Treatment dose/dosing schedule changes, and treatment interruptions
Time frame: Up to 12 months
Other supportive care therapies prescribed while on index treatment
Time frame: Up to 15 months
Treatments prescribed post index treatment
Time frame: Up to 15 months
Treatments for anemia management received after discontinuing the index treatment
Time frame: Up to 15 months
Receipt of stem cell transplant at any time post index treatment
Time frame: Up to 15 months
Participant red-blood cell (RBC) transfusion burden post index treatment
Time frame: At 3-months, and up to 6 months
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Hematologic improvement-erythroid (HI-E) response post index treatment
Time frame: At 3-months, and up to 6 months
Progression to acute myeloid leukemia post index treatment
Time frame: Up to 15 months
Progression to high-risk myelodysplastic syndromes per the International Prognostic Scoring System (IPSS) or its revised version (IPSS-R) criteria
Time frame: Up to 15 months
Participant adverse events during and post index treatment
Time frame: Up to 15 months
Overall survival (OS)
Time frame: At 3-, 6-, 12-, and up to 15-months
Healthcare resource utilization (HCRU) during index treatment
Time frame: Up to 15 months