To evaluate the long-term efficacy and safety after the end of romiplostim treatment by observation \[up to 5 years\] of patients who were registered for Study 531-003/531-004 in immunosuppressive therapy-naïve patients with aplastic anemia.
Study Type
OBSERVATIONAL
Enrollment
36
Kanazawa University, College of Medical Pharmaceutical and Health Sciences, School of Medicine, Department of Hematology
Kanazawa, Ishikawa-ken, Japan
Hematological response at 2 years after the start of romiplostim treatment in Study 531-003/531-004
Time frame: 2 years
Hematological response at up to 5 years after the start of romiplostim treatment in Study 531-003/531-004
Time frame: 5 years
The duration of hematological response, and the presence or absence of occurrence of new chromosomal abnormality or transformation to AML/MDS.
1. Duration of hematological response in patients who achieved hematologic response at the completion of Study 531-003/531-004 2. Time courses of Hb level (g/dL) 3. Time courses of platelet count (/μL) 4. Time courses of neutrophil count (/μL) 5. Presence or absence of platelet blood cell transfusion 6. Presence or absence of red blood cell transfusion 7. Presence or absence of G-CSF product administration 8. Dose level and administration period of cyclosporine A 9. Presence or absence of transformation to MDS/AML 10. Presence or absence of occurrence of new chromosome abnormality 11. Time to the start of subsequent treatment or to death 12. Overall survival
Time frame: 52, 78, 104, 130, 156, 182, 208, 234, 260 weeks
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