Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Drug utilisation
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Population studied

Age groups

  • Adult and elderly population (≥18 years)
    • Elderly (≥ 65 years)
      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)

Estimated number of subjects

554
Study design details

Main study objective

To assess, in real-life settings, the effect of an ESA biosimilar (Retacrit®) on chemotherapy induced anemia response rate(a) and fatigue (FACIT-Fatigue)(b) at 16 weeks in elderly patients (aged 70 years and over) and to confirm the possible relationship between these two criteria.

Outcomes

To determine the impact of an ESA biosimilar (Retacrit®) on performance status at 16 weeks.To assess the modalities of use of an ESA biosimilar (Retacrit®) and its safety on this specific population.

Data analysis plan

Quantitative variables will be described (distribution) in terms of numbers, missing data, mean, standard deviation, median and range. Qualitative variables will be described (distribution) in terms of absolute frequency and percentage per class. The percentage of each type of response will be provided when the variable can take different forms (treatments, adverse events…). The number of missing data will be provided for each variable (the missing data will not be included in the calculation of percentages). In case of comparative analysis, it will be performed with a significance level set at 5% using: The Pearson Chi2 test for qualitative variables. The Student t-test or ANOVA for Gaussian quantitative variables. The non-parametric Mann-Whitney or Kruskal-Wallis test for semi-quantitative or non-Gaussian quantitative variables.