Users of pegfilgrastim less than or equal to 13 years of age (20200114)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Descriptive, retrospective analysis

Study drug and medical condition

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

Population studied

• Short description of the study population:
  Among the patients enrolled in the IBM MarketScan database, patients who received their first, incident, administration of pegfilgrastim from 01 January 2013 to; 31 December 2018 were considered for analysis.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
• Estimated number of subjects:
  600

Study design details

• Main study objective:
  Among pediatric patients ages ≤ 13 years and a subset of patients ages < 2 years, describe the frequency of users of pegfilgrastim, stratified by calendar year (2013 -2018) and stratified by place-of-service of pegfilgrastim administration.
• Outcomes:
  Use of Pegfilgrastim, Place-of-service of administration of Pegfilgrastim
• Data analysis plan:
  The frequency (n,%) will be calculated for pediatric patients exposed to Neulasta that are ages ≤13, a subset of patients that are aged < 2, patients by individual ages (<1, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, and 13), patients aged 0 -< 2, 2 - 5, 6 – 10, 11-13.