Post-marketing surveillance of Lenvima in patients with unresectable thyroid cancer in Japan (LEN01T)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Intensive monitoring schemes, Post-marketing surveillance

Study drug and medical condition

• Name of medicine:
  LENVIMA
• Medical condition to be studied:
  Thyroid neoplasm

Population studied

• Short description of the study population:
  Patients with unresectable thyroid cancer administered Lenvima in Japan.
• 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:
  Thyroid cancer patients
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  To monitor the safety (and efficacy) of lenvatanib in patients with unresectable thyroid cancer in Japan, to assess incidence of adverse events in post marketing setting, e.g. hypertension
• Data analysis plan:
  The analysis method is primarily descriptive: DemographicsConcomitant medicationsAdverse eventsEfficacy (overall response rate and survival at one year)