Post-marketing Surveillance of Ofev Capsules in Chronic (PMS for PF-ILD)

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medicinal product name:
  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:
  Interstitial lung disease

Population studied

• Short description of the study population:
  Inclusion criteria; -Patients in Japan with PF-ILD who are prescribed with Ofev Capsules and have never been treated with Ofev Capsules before enrolment will be included.; ; Exclusion criteria; - Diagnosis of IPF; - Patients with PF-ILD due to systemic scleroderma as the underlying disease
• 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)
• Estimated number of subjects:
  440

Study design details

• Study design:
  This is a non-interventional study based on newly collected data of patients under routine care to confirm safety of Ofev Capsules in the real-world setting in Japanese patients with PF-ILD.
• Main study objective:
  Main objective is to confirm the incidence of adverse drug reactions (ADRs) by overall, each individual (especially focus on the safety specification on J-RMP: hepatic function disorders)
• Setting:
  Sites throughout entire country will be equally listed according the size of the hospitals or general clinics at which Ofev Capsules are available for prescription. ; ; Planned number of sites: Approximately 100 Sites; ; A medical representative will explain the objective and design of this study to investigators at each study site and conclude a written contract with the head of the study site (e.g., hospital director).
• Comparators:
  None
• Outcomes:
  The incidence of adverse drug reactions (ADRs)
• Data analysis plan:
  analyses are descriptive in nature, including confidence intervals.
• Summary results:
  There was no notable difference in the safety profile observed in the PMS and the information provided in the Japanese package insert. The study does not indicate any changes on Risk and Benefit concerning Ofev ; Capsules treatment.