An Open-Label, Multi-Centre, Non-Interventional, Post-Marketing Surveillance (PMS) to Monitor the Safety and Effectiveness of Votrient Administered in Korean Patients According to the Prescribing Information (115578)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Regulatory Post Marketing Surveillance.
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Non-interventional, open-label, single group, multicentre post-marketing surveillance.

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  PAZOPANIB

Population studied

• Short description of the study population:
  Advanced renal cell carcinoma or soft tissue sarcoma patients administered Votrient at the site.
• 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)
• Special population of interest:
  Hepatic impaired

  Immunocompromised

  Renal impaired
• Estimated number of subjects:
  3000

Study design details

• Main study objective:
  To collect safety and effectiveness data of Votrient in Korean patients.
• Outcomes:
  Adverse events in patients administrated Votrient. Unexpected adverse drug reaction (ADR), serious adverse event (SAE) and effectiveness in patients administrated Votrient.
• Data analysis plan:
  Non-interventional, open-label, single group, multicentre post-marketing surveillance.