This study aims to collect real-world data on treatment patterns and clinical outcomes for participants who discontinued Luspatercept or epoetin alfa treatment and discontinued the COMMANDS trial (NCT03682536) utilizing existing data from patient medical records.
Study Type
OBSERVATIONAL
As per COMMANDS Trial (NCT03682536) study protocol
As per COMMANDS Trial (NCT03682536) study protocol
National Taiwan University Hospital (NTUH)
Taipei, Taiwan
Participant treatment patterns: Type of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Duration of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Dosage of treatment received
Time frame: Up to 24 months
Participant treatment patterns: Dosing route of treatment administration
Time frame: Up to 24 months
Participant treatment patterns: Reason for treatment administration
Time frame: Up to 24 months
Participant treatment patterns: Time to next line of therapy (LoT)
Time frame: Up to 24 months
Participant treatment patterns: Reason for treatment discontinuation
Time frame: Up to 24 months
Participant treatment patterns: Type of concomitant medications received
Time frame: Up to 24 months
Participant treatment patterns: Start and end dates of concomitant medications received
Time frame: Up to 24 months
Participant clinical outcomes: Number of units of red blood cell transfusions received
Time frame: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category
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Category 1: Transfusion dependent (at least 4 units of red blood cell (RBC) with 8 weeks for hemoglobin (Hb) \<9g/dL) Category 2: Transfusion independence (\<4 units of RBC with 8 weeks for Hb \<9 g/dL)
Time frame: Up to 24 months
Participant clinical outcomes: Red blood cell transfusion burden (RBC-TB) category per International Working Group (IWG) 2018
IWG 2028 criteria: 1. Non-transfused (0 Red Blood Cells \[RBC\] in 16 weeks) 2. Low-transfusion burden (3-7 RBCs in 16 weeks in at least 2 transfusion episodes, maximum 3 in 8 weeks) 3. High-transfusion burden (≥8 RBCs in 16 week, ≥4 in 8 weeks)
Time frame: Up to 24 months
Participant clinical outcomes: Blood test results
Time frame: Up to 24 months
Participant clinical outcomes: Number of participants that progressed to acute myeloid leukemia (AML) status
Time frame: Up to 24 months
Number of participants that progressed to high-risk myelodysplastic syndromes (MDS)
Time frame: Up to 24 months
Participant clinical outcomes: Participant survival status
Time frame: Up to 24 months
Participant clinical outcomes: Date and primary cause of death
Time frame: Up to 24 months
Participant clinical characteristics
Time frame: Up to 24 months