Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Group 1: Epoetin alfa
epoetin alfa · 43 trials · 40 indications
Progression free survival was based in investigator-determined progressive disease (PD) and calculated from the date of randomization to the date of PD or the date of death, whichever occurred first. Participants who had not progressed and were still alive at the time of clinical cut off were censored at the last disease assessment prior to the clinical cutoff. For PD or death with a missing interval immediately preceding the event, progression-free survival (PFS) was censored at the last disease assessment prior to the missing interval. Participants who withdrew from the study (withdrawal of consent or lost to follow-up) without progression were censored at the time of the last disease assessment.
| Arm | Type | Description |
|---|---|---|
| Epoetin alfa | EXPERIMENTAL | Group 1: Epoetin alfa type = range unit= IU/Kg number= 337.5 to 1050 IU/Kg form= solution for injection route= subcutaneous use weekly injections (max 40 000 IU per week for first 8 weeks of treatment max 80 000 IU per week later) using pre-filled 1mL 40 000 IU syringes for 24 to 48 weeks |
| No treatment | PLACEBO_COMPARATOR | Group 2: Placebo form= solution for injection route= subcutaneous use weekly injections for 24 to 48 weeks |
| 001 | EXPERIMENTAL | epoetin alfa Continue pre-study once weekly dose of epoetin alfa for 36 weeks |
| 003 | EXPERIMENTAL | epoetin alfa Quadruple the pre-study once weekly dose of epoetin alfa every 4 weeks for 36 wk |
| 002 | EXPERIMENTAL | epoetin alfa Double the pre-study once weekly dose of epoetin alfa every 2 weeks for 36 wks |
| Group 2 | OTHER | Standard treatment of anemia excluding use of erythropoetin stimulating agents (ESAs). |
| Name | Type | Description |
|---|---|---|
| Group 2: Placebo | DRUG | form= solution for injection, route= subcutaneous use, weekly injections for 24 to 48 weeks |
| Group 1: Epoetin alfa | DRUG | type = range, unit= IU/Kg, number= 337.5 to 1050 IU/Kg, form= solution for injection, route= subcutaneous use, weekly injections (max 40,000 IU per week for first 8 weeks of treatment, max 80,000 IU per week later) using pre-filled 1mL 40,000 IU syringes for 24 to 48 weeks |
| epoetin alfa | DRUG | Continue pre-study once weekly dose of epoetin alfa for 36 weeks |
| Standard supportive care (packed RBC transfusion) | OTHER | Per doctor prescription |
| epoetin alfa + packed RBC transfusion | DRUG | 40,000 IU SC once a week. |
| Standard of care | OTHER | - |
Inclusion Criteria: * Diagnosis of MDS according to World Health Organization or French-American-British pathologic classification (confirmed via bone marrow aspirate/biopsy) within 12 weeks prior to screening * Documentation of an International Prognostic Scoring System score indicating Low- or In...