Nintedanib

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.

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.

Percentage of patients with Adverse Events (AEs) leading to permanent dose reductions of study drug is reported.

This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.

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.

Treated Set: Patients who met all eligibility criteria and have taken at least one dose of nintedanib.

Outcome measures were not collected for pirfenidone treated patients, since per study protocol for the pirfenidone treated patients only baseline characteristics data were planned to be collected. After the baseline visit the pirfenidone treated patents were not followed.

This arm includes the patients who started treatment with nintedanib after 23rd January 2017 and were continuing the drug at the time of participation in the active surveillance (group B) and patients who were newly prescribed nintedanib at the time of participation in the active surveillance (group C). Initial dose in adult patients was Nintedanib 150 milligram (mg) twice daily orally administered with food in morning and evening. According to the Indian label the dosage could be reduced to nintedanib 100 mg twice daily according to the patient's symptoms or in case of adverse events.