An Observational Study to Assess the Effectiveness of the Neulasta® Patient Alert Card and to Measure Medication Errors Related to the Use of the Neulasta® On-Body Injector (20170701)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Observational study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PEGFILGRASTIM
• Medical condition to be studied:
  Neutropenia

  Febrile neutropenia

Population studied

• Short description of the study population:
  Patients aged 18 years or more who were prescribed the on-body injector (OBI for Neulasta delivery for their current chemotherapy cycle in 3 EU countries: Belgium, Germany, and Slovakia.; Inclusion criteria: ; − Respondent (ie, patients or caregivers primarily responsible for monitoring the OBI) who agrees to be contacted for the questionnaire. ; − Respondent aged 18 or more years.; − Respondent with no cognitive impairment.; − Respondent who can read and understand the language in which the study is being conducted and in which the PAC is provided.; − Patient has been prescribed the OBI for Neulasta delivery for their current ; chemotherapy cycle.; − Patient and respondent provide their written informed consent to participate in the study. ; ; Exclusion criteria: ; − Respondent personally works, or works on a consultancy basis, for any pharmaceutical company or advertising/research agency.; − Patient has participated or is participating in a clinical trial of Neulasta administered via OBI.
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  80

Study design details

• Main study objective:
  The primary objective of the study is to assess respondent awareness of key safety messages and behavioural intent to carry out recommended actions as described in the PAC.
• Outcomes:
  Awareness of key safety messages and behavioural intent to carry out recommended actions as described in the PAC: will be evaluated using a set of multiple choice questions included in the questionnaire. A composite score for each individual will be calculated based on the proportion of all awareness and behavioural intent questions with correct responses. • To determine if the respondent received the PAC. • To estimate the proportion of OBI administrations associated with medication error.
• Data analysis plan:
  All analyses will be descriptive. Continuous variables will be summarised by mean, median, standard deviation, Q1, Q3, minimum, maximum, 95% confidence intervals and number of valid and missing values for outcome variables. Categorical variables will be summarised by number and percentage of responses per category and 95% confidence intervals for outcome variables. The number of valid and missing values will be reported for each variable. Missing values will not be included in the denominator to calculate the percentage of responses per response category.