Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

Incidence Rate of All ADRs in Nintedanib Treated Patients

Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients is reported. An adverse reaction is defined as at least a reasonable possibility of a causal relationship between a suspected medicinal product and an adverse event. Incidence rate was calculated using the number of patients with ADRs events per treatment divided by time at risk expressed as \[100 patient-years (pt-yrs)\]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.

Incidence Rate of All SAEs in Nintedanib Treated Patients

Incidence rate of all Serious Adverse Events (SAEs) in nintedanib treated patients is reported. A SAE was defined as any adverse event which: * results in death, * is life-threatening, * requires in-patient hospitalization, or * prolongation of existing hospitalisation, * results in persistent or significant disability or incapacity, or * is a congenital anomaly/birth defect. Incidence rate was calculated using the number of patients with SAEs events per treatment divided by time at risk expressed as \[100 patient-years (pt-yrs)\]. Time at risk was calculated as below: If patients with AE: Time at risk= (start date of first AE- start date of treatment administration) +1; If patients without AE: Time at risk= (end of date at risk (date of study completion or date of discontinuation or last visit date available)-start date of treatment administration) +1.

Time frame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.