All donors who have received pegfilgrastim for the first time after the date of approval of the indication "
Conditions
Interventions
None listed
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: All donors who have received pegfilgrastim for the first time after the date of approval of the indication " Mobilization of Hematopoietic Stem Cells into Peripheral Blood for Allogeneic Blood Stem Cell Transplantation "
Exclusion criteria
Exclusion criteria: -The contract with the facility has not been concluded -Outside the contract period with the facility -Peripheral blood stem cell collection using a daily G-CSF other than pegfilgrastim* *Registration is possible if peripheral blood stem cell collection was performed using a daily G-CSF other than pegfilgrastim in the past. -This is not the first time to collect peripheral blood stem cells by administration of pegfilgrastim -Duplicate registration (already registered)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety -Incidence of adverse reactions -Incidence of adverse drug reactions and infectious diseases -Examination of Safety specifications -Examination of other adverse events (headache, liver dysfunction, etc.) -Safety after peripheral blood stem cells collection -Factors that may affect safety | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy -Securing the number of peripheral blood stem cells required for transplantation -Factors that may influence the evaluation of efficacy | — |
Countries
Japan
Contacts
Kyowa Kirin Co., Ltd. Pharmacovigilance Department