Study type

Study topic

Human medicinal product

Study type

Non-interventional study

Scope of the study

Drug utilisation
Effectiveness study (incl. comparative)
Other

If ‘other’, further details on the scope of the study

Observe disease-related baseline characteristics at initiation of treatment
Non-interventional study

Non-interventional study design

Other

Non-interventional study design, other

Retrospective multi-centre observational study
Study drug and medical condition

Name of medicine

ARANESP

Study drug International non-proprietary name (INN) or common name

DARBEPOETIN ALFA

Anatomical Therapeutic Chemical (ATC) code

(B03XA02) darbepoetin alfa
darbepoetin alfa

Medical condition to be studied

Anaemia
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

1625
Study design details

Main study objective

The primary objective of this study is to describe the baseline hemoglobin (Hb) levels at initiation of treatment with erythropoiesis stimulating agent (ESA) in participants receiving myelosuppressive chemotherapy.

Outcomes

Hb level in g/dL at initiation of ESA, further categorised in 2 alternative ways, as per product label and clinical trial criteria.
• Hb ≤10 g/dL
• Hb ≤11 g/dL, Demographic characteristics, average prescription length of ESA, number of participants with ESA prescribed at Weeks 3, 4, 6, 9, prescribed dose, frequency and dose modifications, Hb level during ESA treatment, change in Hb level during ESA treatment.

Data analysis plan

For the primary objective, the number and proportion (%) of patients receiving myelosuppressive chemotherapy with a baseline Hb level of
• 10 g/dL (as per SmPC criteria), and
• 11 g/dL (as per 20070782 clinical trial criteria) prior to or at initiation of ESA treatment will be summarized with descriptive statistics.
Point estimates for the proportions, mean, and median will be presented with 95% confidence intervals (CI) for proportion and mean estimates and 1st and 3rd quartiles for median estimates. Patient demographics, clinical characteristics, type of ESA will be summarized with descriptive statistics overall and by ESA type, and country, where appropriate. The number of weeks of treatment with an ESA and starting dose, dose frequency and any dose modifications will also be summarized. All analyses will be stratified by ESA type, type of malignancy and country.