Observational, multicentre, prospective, real-world post-authorization safety study describing the achievement of nintedanib-associated DIArrhoea control after 12 weeks of follow-up in patients with idiopathic puLmonary FIBrosis (IPF) and progressive pulmonary fibrosis (other than IPF) in Spain: the DIALFIB study

Study type

• Study topic:
  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Disease epidemiology

  Other
• If ‘other’, further details on the scope of the study:
  Nintedanib associated diarrhoea control
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cohort

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:
  (B02A) ANTIFIBRINOLYTICS

  ANTIFIBRINOLYTICS
• Medical condition to be studied:
  Diarrhoea

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:
  100

Study design details

• Main study objective:
  To describe the proportion of patients who achieve diarrhea control while taking a nintedanib dose of 150 mg bid at 12-week follow up in patients with IPF and other PPF reporting a first episode of nintedanib-associated diarrhea at study baseline.
• Outcomes:
  Achievement of diarrhea control (yes/no), defined as the passage of less than 3 loose or liquid stools in a 24-hour period (loose or liquid stools defined as stools with a BSFS of 6 or 7 points (17))while being treated with 150 mg bid of nintedanib, at 12-week follow-up. ; 1. Absolute change in the proportion of patients taking optimal nintedanib dose (150 mg bid) at 12-week follow-up referent to baseline ; 2. Absolute change in BSFS score at week 12 follow-up referent to baseline ; 3. Absolute change in number of stools per day at 12-week follow-up referent to baseline ; 4. Absolute change in current body weight (in kilograms) at 12-week And 6 more
• Data analysis plan:
  Descriptive statistics will be presented as absolute (counts) and relative frequencies (proportions) for categorical variables, and mean, standard deviation, median, 25 and 75 quartiles, and minimum, and maximum values for continuous variables.