A Prospective Observational Study to Estimate the Incidence of Febrile Neutropenia (FN) among Subjects with Non-myeloid Malignancies at High Risk for FN and receiving Neulasta® (pegfilgrastim) Onpro® kit or Other Physician Choice Options for Prophylaxis of FN (20170758)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/44447
• EU PAS number:
  EUPAS24626
• Study ID:
  44447
• Official title and acronym:
  A Prospective Observational Study to Estimate the Incidence of Febrile Neutropenia (FN) among Subjects with Non-myeloid Malignancies at High Risk for FN and receiving Neulasta® (pegfilgrastim) Onpro® kit or Other Physician Choice Options for Prophylaxis of FN (20170758)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Multiple centres: 150 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 03/01/2018

Actual: 03/01/2018

Study start date

Planned: 14/11/2018

Actual: 07/11/2018

Data analysis start date

Planned: 03/10/2020

Actual: 01/12/2020

Date of final study report

Planned: 04/06/2021

Actual: 25/11/2021

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

EUPAS24626-25197

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable