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

Study identification

• EU PAS number:
  EUPAS27161
• Study ID:
  29286
• Official title and acronym:
  Users of pegfilgrastim less than or equal to 13 years of age (20180440) (Users of pegfilgrastim =< 13 years)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  On 08 November 2018, FDA requested following information from Amgen: “Describe the trends and use of Pegfilgrastim Injection in U.S. pediatric patients weighing less than 45 kg (using ≤13 years of age as a surrogate for weight) in the last 3 years”. We will use the MarketScan commercial claims database to identify users of pegfilgrastim 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. The results will be stratified by age at first administration (≤13 y vs. > 13 y) and reported by 12-month intervals
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 14/12/2018

Actual: 14/12/2018

Study start date

Planned: 14/12/2018

Actual: 14/12/2018

Data analysis start date

Planned: 14/12/2018

Actual: 14/12/2018

Date of final study report

Planned: 15/03/2019

Actual: 03/03/2019

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable