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Iron isomaltoside 1000

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Observation of real-life treatment with iron isomaltoside 1000 / Iron Derisomaltose 1000

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.

Real Life Study on Iron Isomaltoside 1000 in the Treatment of ID in CKD, Heart Failure, ObGyn, IBD, Cancer and Elective Surgery (Real-CHOICE).

Iron Isomaltoside 1000 in Patients With Iron Deficiency or Iron Deficiency Anemia: a Multicentric, Prospective, Longitudinal, Observational Study in Switzerland.

Rate of patients with stability or positive change in attitude.

Questionnaire comprises the following questions:

1. I am hesitant to be treated with IV iron.
2. I would consider IV iron treatment due to the physician ́s choice.
3. I would consider IV iron treatment due to its safety compared to other iron treatment options.
4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.

Iron deficiency anemia (IDA): Hb (Hemoglobin) increase ≥ 1 g/dL.

Iron deficiency without anemia (IDNA): Maintenance of baseline Hb-level and/or Hb above lower limit of normal (LLN).

Taking into account baseline (BL) and follow-up (FU) answers.

Questionnaire comprises the following questions:

1. I am hesitant to be treated with IIM.
2. I would consider IIM treatment due to the physician ́s choice.
3. I would consider IIM treatment due to its safety compared to other iron treatment options.
4. I would consider IIM treatment due to its efficacy compared to other iron treatment options.
5. I would consider IIM treatment due to its specific dosing and administration schedule.

Questionnaire comprises the following questions:

1. I am hesitant to treat with IV iron.
2. I would consider IV iron treatment due to the patient ́s desire.
3. I would consider IV iron treatment due to its safety compared to other iron treatment options.
4. I would consider IV iron treatment due to its efficacy compared to other iron treatment options.

And:

1. I am hesitant to treat with IIM.
2. I would consider IIM treatment due to the patient ́s desire.
3. I would consider IIM treatment due to its safety compared to other iron treatment options.
4. I would consider IIM treatment due to its efficacy compared to other iron treatment options.
5. I would consider IIM treatment due to its specific dosing and administration schedule.

Difference between administered IIM dose and calculated iron need.

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.

Rate of physicians and patients with stability or positive change in satisfaction upon IIM treatment.

Number of patients with:

* Treatment-emergent adverse events (maximum grade per patient),
* Grade 3/4 treatment-emergent adverse drug reactions,
* Grade 3/4 treatment-emergent serious adverse events,
* Treatment-emergent serious adverse drug reactions,
* Pre-treatment adverse events,
* Pre-treatment serious adverse events,
* Follow-up adverse events,
* Follow-up serious adverse events.

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