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

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/37383
• EU PAS number:
  EUPAS34153
• Study ID:
  37383
• Official title and acronym:
  Users of pegfilgrastim less than or equal to 13 years of age (20200114)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  To describe the frequency (n, %) of pegfilgrastim-use in pediatric patients ages less than or equal to 13 and within a subset of patients aged < 2, stratified by calendar year and place-of-service for administration of pegfilgrastim.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Planned: 02/03/2020

Actual: 02/03/2020

Study start date

Planned: 03/03/2020

Actual: 03/03/2020

Data analysis start date

Planned: 16/03/2020

Actual: 16/03/2020

Date of final study report

Planned: 31/08/2020

Actual: 25/09/2020

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS34153-35209

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Non-EU RMP only