The special drug use-results survey (All-Case Surveillance) of Ofev® Capsules in patients with Idiopathic Pulmonary Fibrosis (IPF) in Japan

Study type

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

  Effectiveness study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Prospective, observational, single arm

Study drug and medical condition

• Name of medicine:
  OFEV 100 MG - CAPSULE, SOFT

  OFEV 150 MG - CAPSULE, SOFT
• 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

Population studied

• 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:
  5200

Study design details

• Main study objective:
  To evaluate the real-world safety and effectiveness of Ofev Capsules treatment in patients with IPF
• Outcomes:
  The frequency of patients with any suspected adverse drug reactions, The absolute change from the baseline in Forced Vital Capacity (FVC) mL at Week 104.
• Data analysis plan:
  Analyses are descriptive in nature including means, standard deviation, Q1, medians, Q3, frequency and percentages. For safety outcomes, incidence rates with corresponding 95% confidence intervals will also be calculated. For the effectiveness outcomes, the point estimate and 95% confidence intervals from statistical models will also be calculated for exploratory purpose.