Assessment of safety of Diphereline® SR 11.25 mg in Polish patients with prostate cancer (A-38-52014-163)

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/30162
• EU PAS number:
  EUPAS7938
• Study ID:
  30162
• Official title and acronym:
  Assessment of safety of Diphereline® SR 11.25 mg in Polish patients with prostate cancer (A-38-52014-163)
• DARWIN EU® study:
  No
• Study countries:
  Poland
• Study description:
  This national, post marketing multicentre, observational, non-controlled study designed to formally assess the safety of Diphereline® SR during 12-month observation in patients with locally advance or invasive prostate cancer in normal clinical practice. Only patients who started therapy with Diphereline® SRwere considered as the study participants. The study documents (CRF) recorded justification for the prescription of Diphereline® SR, clinical stage (TMN classification) and grade (Gleason score) of prostate cancer, concomitant diseases and medication. The main outcome is the assessment of adverse (AE) or Serious Adverse Event (SAE) and Adverse Drug Reaction (ADR) related to the use of Diphereline® SR recorded during every 3-months visits necessary for Diphereline® SR injection.
• Study status:
  Finalised

Research institutions and networks

Institutions

Ipsen Pharma

Multiple centres: 210 centres are involved in the study

Study timelines

Date when funding contract was signed

Planned: 01/08/2008

Actual: 01/08/2008

Study start date

Planned: 31/08/2008

Actual: 31/10/2008

Date of final study report

Planned: 30/09/2010

Actual: 30/09/2010

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Ipsen

Regulatory

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