An active surveillance to monitor the real world safety in Indian patients prescribed nintedanib for the treatment of Idiopathic Pulmonary Fibrosis

Study type

• Study type:
  Non-interventional study
• Scope of the study:
  Other
• If ‘other’, further details on the scope of the study:
  Safety of nintedanib in IPF patients in Indian real world setting

Non-interventional study

• Non-interventional study design:
  Cohort

  Other
• Non-interventional study design, other:
  The design of this active surveillance is of non-interventional nature and will be conducted within the conditions of the approved marketting authorisations

Study drug and medical condition

• Name of medicine, other:
  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:
  400

Study design details

• Main study objective:
  The main objective of this study is to examine the safety of nintedanib in IPF patients in Indian real world setting.
• Outcomes:
  The primary outcome is Occurrence of ADRs (serious and non-serious) in nintedanib treated patients & Occurrence of AEs (serious and fatal) in nintedanib treated patients. The secondary outcome is Percentage of patients who require dose reductions and discontinuation due to adverse events.
• Data analysis plan:
  Analyses will be descriptive in nature including means, medians, standard deviation and interquartile range for continuous variables, and frequencies and percentages for binary and categorical variables with the corresponding 95% confidence intervals. For safety outcomes, incidence rates with corresponding 95% confidence intervals will be calculated. Baseline characteristics of consecutive 100 IPF patients not treated with nintedanib will be used to compare the patients profile with the nintedanib users and will allow us to put the safety data of nintedanib into perspective.

Documents

Study results

1199-0280-NIS Report