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Real-CHOICE - designed as a prospective, longitudinal, observational, non-interventional study - will investigate the attitude of patients and physicians towards IV (intravenous) iron therapy in general and IIM (iron isomaltoside 1000) treatment particularly before and after IIM treatment in iron deficient patients with or without anemia in the real-world clinical setting after commercial availability of this product in Switzerland.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Iron isomaltoside 1000 | Drug | Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Attitude of patients towards IV iron treatment evaluated with questionnaire. | Rate of patients with stability or positive change in attitude. Questionnaire comprises the following questions:
| Change from baseline taking into account baseline (BL) and follow-up (FU) answers. Follow-up at the latest 12 weeks after observed dosing and before a potential subsequent dosing (if available based on clinical routine follow-up). |
| Measure | Description | Time Frame |
|---|---|---|
| Effectiveness of treatment with IIM. | Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients with iron deficiency (IDNA) or iron deficiency anemia (IDA) treated at the treating physician's discretion with IIM according to the Swiss SmPC for Monofer® in current practice.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 21 | Basel | Switzerland | ||||
| 9 |
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Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN). |
| Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Attitude of patients towards IIM treatment evaluated with questionnaire. | Taking into account baseline (BL) and follow-up (FU) answers. Questionnaire comprises the following questions:
| Complete observation time-frame (the total observation period of this study will amount to 90 months). |
| Attitude of physicians towards IIM and IV iron treatment evaluated with questionnaire. | Questionnaire comprises the following questions:
And:
| Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Patient and disease profiles at baseline. | Evaluation of kind of iron deficiency. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Patient and disease profiles at baseline. | Institution of diagnosis of IDA/IDNA. | Baseline. |
| Patient and disease profiles at baseline. | Etiology of iron deficiency. | Baseline. |
| Patient and disease profiles at baseline. | Method of iron need determination. | Baseline. |
| Calculation of iron need based on IIM simplified dosing scheme. | Evaluation of dosing intensity of IIM. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Calculation of iron need based on IIM simplified dosing scheme. | Calculated iron need. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Calculation of iron need based on IIM simplified dosing scheme. | Determined iron need. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Calculation of iron need based on IIM simplified dosing scheme. | Difference between administered IIM dose and calculated iron need. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment sequence before IIM. | Dose intensities of administration. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment sequence before IIM. | Dose intervals of administration. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Reason(s) for selection of IIM. | Reasons for treatment choice of IIM in current patient populations. Reasons could be: efficacy, safety profile, quality of life, patient's preference, physician's preference, comorbidities, convenient dosing, other. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment with IIM. | Dose intensity of administration. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment with IIM. | Mode of administration. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment with IIM. | Duration of infusion. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Treatment satisfaction of physician and patient upon treatment. | Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: whole blood count changes. | Red blood cell count | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: whole blood count changes. | White blood cell count | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: whole blood count changes. | Hemoglobin | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: whole blood count changes. | Hematocrit | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: whole blood count changes. | Platelets | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: total Hb increase. | Hemoglobin | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: serum ferritin increase. | Serum ferritin | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: serum ferritin increase. | Transferrin saturation (TfS) | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: serum ferritin increase. | Soluble transferrin receptor (sTfR) | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: serum ferritin increase. | Phosphate level | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Effectiveness of treatment with IIM: CRP (C-reactive protein) status. | CRP status. | Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Safety and tolerability of treatment with IIM, including frequency and severity of treatment-emergent AEs (Adverse Events) / ADRs (Adverse Drug Reactions). | Number of patients with:
| Complete observation time-frame (the total observation period of this study per patient will amount to 3 months). |
| Basel |
| Switzerland |
| 1 | Bern | Switzerland |
| 15 | Biel | Switzerland |
| 19 | Brugg | Switzerland |
| 18 | Gossau | Switzerland |
| 11 | Kreuzlingen | Switzerland |
| 12 | Kreuzlingen | Switzerland |
| 8 | Kreuzlingen | Switzerland |
| 5 | Liestal | Switzerland |
| 20 | Opfikon | Switzerland |
| 16 | Rheinfelden | Switzerland |
| 13 | Sankt Gallen | Switzerland |
| 17 | Sankt Gallen | Switzerland |
| 7 | Sion | Switzerland |
| 6 | Spreitenbach | Switzerland |
| 14 | Steinach | Switzerland |
| 10 | Wettingen | Switzerland |
| 3 | Wohlen | Switzerland |
| 2 | Zurich | Switzerland |
| 4 | Zurich | Switzerland |
| ID | Term |
|---|---|
| D018798 | Anemia, Iron-Deficiency |
| ID | Term |
|---|---|
| D000747 | Anemia, Hypochromic |
| D000740 | Anemia |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D000090463 | Iron Deficiencies |
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C557707 | iron isomaltoside 1000 |
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