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

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Post-marketing Observational Study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (L02AE04) triptorelin

  triptorelin
• Medical condition to be studied:
  Prostate cancer

Population studied

• Short description of the study population:
  Patients with locally advance or invasive prostate cancer in normal clinical practice. Only patients who started therapy with Diphereline® SR were considered as the study participants.
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Special population of interest:
  Other
• Special population of interest, other:
  Prostate cancer patients
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  Primary objective: monitoring of the safety of Diphereline® SR 11.25 mg in general practice.Secondary objective: safety in locally advanced and metastatic prostate cancer.
• Outcomes:
  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.
• Data analysis plan:
  Statistical analyses were performed with the use of STATISTICA 8.0 PL software. Distribution of quantitative variables were shown by mean values and standard deviations, and of qualitative variables by absolute and relative frequencies. Medical Dictionary for Regulatory Activities (MedDRA, version not specified) dictionary was used to code separately AE and SAE. The frequency of AE and ADR was calculated for the population exposed for at least one dose of Diphereline ® SR 11.25 mg.