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

Browse trials for

• Pulmonary Fibrosis 680
• Idiopathic Pulmonary Fibrosis 551
• Fibrosis 3,255

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 21 is below the median of 130 across 229 observational studies indexed under Pulmonary Fibrosis.

Lead sponsor

Boehringer Ingelheim is the lead sponsor of 2,245 studies on the registry; 58 are open to participants now.

Of its 162 completed or terminated interventional studies of FDA-regulated products, 116 (72%) have results posted.

Study population

Groups and cohorts

• All nintedanib treated patients (group B + group C)

  Drug: Nintedanib

• Group II- pirfenidone patients

  Drug: Pirfenidone

• Group III - pirfenidone patients

  Drug: Pirfenidone

Interventions

• DrugNintedanib

  Nintedanib

• DrugPirfenidone

  Pirfenidone

Primary outcomes

1. 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.

2. 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.

Secondary outcomes

1. Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug

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

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

2. Percentage of Patients With AEs Causing Dose Interruption of Study Drug

   Percentage of patients with Adverse Events (AEs) causing dose interruption of study drug is reported.

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

3. Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug

   Percentage of patients with adverse events (AEs) leading to permanently discontinuation of study drug is reported. Percentages are rounded to one decimal places.

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

Baseline characteristics

Related links

• Related Info ↗

Study documents

• Study protocol · Aug 1, 2018
• Statistical analysis plan · Mar 15, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No — Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency