Safety of nintedanib in real world in China: a non interventional study based on Idiopathic Pulmonary (Interstitial) Fibrosis Registry China Study (PORTRAY) data

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Cohort

Study drug and medical condition

• Medical condition to be studied:
  Idiopathic pulmonary fibrosis

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)
• Estimated number of subjects:
  800

Study design details

• Main study objective:
  To evaluate the incidence rates of ADRs and fatal AEs among IPF patients in China who initiate nintedanib during the study period.
• Outcomes:
  The primary outcomes (safety outcomes) will only be assessed for the nintedanib group. Patient follow-up will start from the index date and will end when one of the situations listed below occurs, whichever occurs first: • Death, • Loss of follow-up, • 4 weeks after the discontinuation of nintedanib, • The end of the PORTRAY study follow-up, Mean age at baseline of IPF patients in China who are new usersof nintedanib, new users of pirfenidone, and those who receiveneither of the two antifibrotic drugs. Percentage of each gender of IPF patients in China who are new users of nintedanib, new users of pirfenidone, and those who receive neither of the two antifibrotic drugs
• Data analysis plan:
  The study is descriptive in nature. For continuous data, descriptive statistics (mean, standard deviation SD, minimum, median, interquartile range IQR, and maximum) will be presented. Categorical data will be presented as frequency and incidence rate with 95% CI or counts with percentages as appropriate.