Post Authorization Safety Study of Nintedanib in the treatment of patients with Idiopathic Pulmonary fibrosis in Argentina

Study type

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

  Safety study (incl. comparative)

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prescription event monitoring

Study drug and medical condition

• Name of medicine:
  OFEV
• 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:
  20

Study design details

• Main study objective:
  The main objective of this study is to describe the safety and effectiveness of nintedanib in clinical practice
• Outcomes:
  Primary objective is to determine all adverse events of nintedanib use. Secondary objective is to evaluate the effectiveness of nintedanib.
• Data analysis plan:
  Descriptive statistics will be mainly used in the analysis. Categorical variables will be individually listed and summarized. Number of patients, standard deviations, mean, percentages will be used with graphics and tables when appropriate. Kaplan Meir curves will be used where appropriate.No imputation is planned for missing data.