Post-marketing Surveillance (PMS) on long term use of Ofev Capsules in Systemic Scleroderma associated Interstitial Lung Disease (SSc-ILD) in Japan (PMS for Ofev (SSc-ILD))

Study type

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

  Disease epidemiology

  Drug utilisation

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  Longitudinal study

Study drug and medical condition

• Name of medicine:
  OFEV
• Medical condition to be studied:
  Interstitial lung disease

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:
  550

Study design details

• Main study objective:
  Main objective is to confirm the incidence of adverse drug reactions (focus on gastrointestinal symptoms including diarrhea and nausea).
• Outcomes:
  The incidence of adverse drug reactions (ADRs)
• Data analysis plan:
  Analyses are descriptive in nature, including confidence intervals.