aplastic anemia
Conditions
Interventions
None listed
Sponsors
Kyowa Kirin Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients whose written consent to participate in this research was obtained among patients registered for Study 531-003/531-004 Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients whose legally authorized representatives such as their family had given the consent or patients whose legally authorized representatives had not refused in the disclosure of information by opt-out Of the patients who died before their consent to participate in this research was obtained among those registered for Study 531-003/531-004, patients, patients for whom the consent process exemption was approved by the Ethics Review Committee, etc. of the participating medical institutions at the participating medical institutions in the countries without the opt-out system
Exclusion criteria
Exclusion criteria: Patients who are judged by the investigator or sub-investigator to be unfavorable for participation in this research
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Presence or absence of hematological response at 2 years and up to 5 years after the start of romiplostim treatment in study 531-003/531-004 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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, platelet count, and neutrophil count 3) Presence or absence of platelet/red blood cell transfusion and G-CSF product administration 4) Dose level and administration period of cyclosporine A 5) Presence or absence of transformation to MDS/AML and presence or absence of occurrence of new chromosome abnormality 6) Time to the start of subsequent treatment or to death 7) Overall survival | — |
Countries
Japan,Asia(except Japan)
Contacts
Public ContactMasaru Gamou
Kyowa Kirin Co., Ltd. Medical Affairs
Outcome results
None listed