A regulatory requirement non-interventional study to monitor the safety and effectiveness of Ofev (Nintedanib, 150mg/100mg, BID) in Korean patients

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study

Study drug and medical condition

• Name of medicine:
  OFEV
• Study drug International non-proprietary name (INN) or common name:
  NINTEDANIB
• Anatomical Therapeutic Chemical (ATC) code:
  (L01EX09) nintedanib

  nintedanib
• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

  Interstitial lung disease

Population studied

• 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

  Renal impaired
• Estimated number of subjects:
  59

Study design details

• Main study objective:
  The primary objective is to monitor the safety profile of Ofev in Korean patient in a routine clinical setting.
• Data analysis plan:
  Descriptive analysis will be performed.