Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Reviewing Spanish record of myelodysplastic syndromes (RESMD) data base in the group of patients with MDS. The information will be collected retrospectively from diagnosis of MDS, until the date of December 31, 2011.
Review of RESMD data base in the group of patients with MDS from diagnosis of low risk myelodysplastic syndrome (MDS) and occurrence of anemia that began treatment with erythropoiesis stimulating agent (ESAs) / support transfusional before December 31, 2011. In all cases, data obtained will be prior to the date of the start of the study to ensure its retrospective nature, thus reflecting the routine use of erythropoietic agents in clinical and non-interference in the doctor's clinical practice.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| erythropoiesis-stimulating agents | Patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1), treated with erythropoiesis-stimulating agents. | ||
| Transfusion support | A control group of patients who received only transfusional support. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Collect and evaluate the Spanish experience of anemia treatment. | Collect and evaluate retrospectively the Spanish experience of anemia treatment in patients diagnosed with low-risk MDS according to IPSS (low or intermediate-1) evaluating the efficacy and safety of treatment with ESAs received for at least 24 weeks and the evolution of a control group of patients who received only transfusional support. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of response | In responders at week 24 of treatment, determine the duration of response after 48 weeks of treatment. | 6 months |
| Overall survival. | Evaluate overall survival in the two groups of patients, support transfusional versus ESA. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients diagnosed with MDS according to WHO classifications or FAB low-risk (IPSS low and intermediate-1) with anemia (Hb ≤ 11 g / dL) and treatment (support / ESA) started before December 31, 2011.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maria Consuelo Cañizo, MD | University of Salamanca | Study Chair |
| María Díez, MD | University of Salamanca | Study Chair |
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | May 15, 2019 | |
| Reset | Jul 26, 2019 | |
| Release | Aug 31, 2021 | |
| Reset | Sep 24, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 15, 2019 | Jul 26, 2019 | |||
| Aug 31, 2021 |
| ID | Term |
|---|---|
| D009190 | Myelodysplastic Syndromes |
| ID | Term |
|---|---|
| D001855 | Bone Marrow Diseases |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months |
| Adverse events | Security: To determine the frequency, type, intensity and severity of adverse events and their possible relationship with the various ESA and progression to acute myelogenous leukemia. | 6 months |
| Sep 24, 2021 |