Risk factors For Bone Pain among Neulasta® Users (20120320)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/10330
• EU PAS number:
  EUPAS5644
• Study ID:
  10330
• Official title and acronym:
  Risk factors For Bone Pain among Neulasta® Users (20120320)
• DARWIN EU® study:
  No
• Study countries:
  Australia

  Austria

  Belgium

  Canada

  France

  Germany

  Italy

  Luxembourg

  Mexico

  Netherlands

  Poland

  Portugal

  Russian Federation

  Spain

  Sweden

  United Kingdom

  United States
• Study description:
  The purpose of this study is to identify risk factors for developing bone pain among Neulasta® users. Patient data from 23 pegfilgrastim clinical trials were analyzed. Multivariable logistic regression models were used to evaluate risk factors associated with moderate to severe (grade ≥ 2) bone pain and any grade bone pain in the first chemotherapy cycle and across cycles 1–6.
• Study status:
  Finalised

Research institutions and networks

Institutions

Amgen

United States

Study timelines

Date when funding contract was signed

Actual: 13/08/2012

Study start date

Actual: 15/08/2012

Data analysis start date

Actual: 12/02/2013

Date of final study report

Planned: 01/05/2014

Actual: 13/07/2015

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Amgen

Study protocol

Initial protocol

Neulasta_20120320_Protocol_11Feb14

Regulatory

• Was the study required by a regulatory body?:
  No