Prospective, multi-country, observational registry to collect clinical

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Drug utilisation

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective Observational study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (J02AB02) ketoconazole

  ketoconazole
• Medical condition to be studied:
  Cushing's syndrome

Population studied

• Age groups:
  • Paediatric Population (< 18 years)

    • Adolescents (12 to < 18 years)
  • 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:
  200

Study design details

• Main study objective:
  The primary objective is to collect and assess safety data with a particular focus on the important identified risks of hepatotoxicity and QT prolongation.
• Outcomes:
  Incidence of hepatotoxicity in case of liver enzymes increase and time to onset since ketoconazole initiation and time to recovery. Incidence of QTc prolongation and time to onset since ketoconazole initiation and time to recovery. The secondary endpoints for secondary objectives are the following: - Other Safety and Tolerability endpoints - Drug utilisation pattern endpoints - Effectiveness endpoints - QoL endpoint
• Data analysis plan:
  Details of the data analysis will be provided in a Statistical Analysis Plan (SAP).