Angiotensin II receptor blockers and risk of cancer after contamination with N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA) (Sartans contamination -feasibility study)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Feasibility analysis
• Data collection methods:
  Secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Sample size calculation

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (C09CA) Angiotensin II receptor blockers (ARBs), plain

  Angiotensin II receptor blockers (ARBs), plain
• Medical condition to be studied:
  Malignant neoplasm of unknown primary site

Population studied

• Short description of the study population:
  Patients who had received angiotensin II receptor blockers
• Age groups:
  • Adult and elderly population (≥18 years)

    • Adults (18 to < 65 years)

      • Adults (18 to < 46 years)
      • Adults (46 to < 65 years)
    • Elderly (≥ 65 years)

      • Adults (65 to < 75 years)
      • Adults (75 to < 85 years)
      • Adults (85 years and over)
• Estimated number of subjects:
  16000000

Study design details

• Main study objective:
  The objectives of this feasibility analysis are:• to estimate the sample size (number of exposed patients) that would be needed to identify an excess risk of cancer associated with sartans under different assumptions about the background rate of cancer in Europe and assumptions of the relative risk. • to identify European population databases that would be appropriate to analyse this risk
• Outcomes:
  All types of cancer excluding non-melanoma skin cancer.
• Data analysis plan:
  We will perform sample size calculation for a cohort study with two equal exposed arms, across a range of background risk estimates and relative risks.