Users of pegfilgrastim less than or equal to 13 years of age (20180440) (Users of pegfilgrastim =< 13 years)

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:
  Retrospective data 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:
  Users of pegfilgrastim identified as patients who received their first administration of pegfilgrastim between 01 Jan 2013 and 31 Dec 2017 without any prior use of pegfilgrastim from IBM Truven MarketScan Commercial Claims Database, United States.
• Age groups:
  • Paediatric Population (< 18 years)

    • Neonate

      • Preterm newborn infants (0 – 27 days)
      • Term newborn infants (0 – 27 days)
    • Infants and toddlers (28 days – 23 months)
    • Children (2 to < 12 years)
    • Adolescents (12 to < 18 years)
  • 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:
  100000

Study design details

• Main study objective:
  Describe the users of pegfilgrastim between 01/01/2013 and 01/01/2017, stratified by age ≤13 y vs. > 13 y and calendar year
• Data analysis plan:
  In the MarketScan database, users of pegfilgrastim will be identified as patients who received their first administration of pegfilgrastim between 01 Jan 2013 and 31 Dec 2017 without any prior use of pegfilgrastim. Users of pegfilgrastim will be identified in the database as patients with at least one claim with HCPCS code (“J2505”, “C9119”, “S0135”) or at least once claim with NDC code (“54868522900”, “55513019001”, “55513019201”) for pegfilgrastim. There will be no continuous enrollment required for users of pegfilgrastim. The age of users of pegfilgrastim will be defined as the difference between year of first pegfilgrastim administration and year of birth (date of birth is not available in the database). The results will be stratified by age at first administration (≤13 y vs. > 13 y) and reported by 12-month intervals.