2020
DOI: 10.1007/s12325-020-01452-5
|View full text |Cite
|
Sign up to set email alerts
|

Safety of Nintedanib in Patients with Idiopathic Pulmonary Fibrosis: Global Pharmacovigilance Data

Abstract: Introduction: The safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis (IPF) have been characterized using data from clinical trials. Methods: We further characterized the safety and tolerability of nintedanib in patients with IPF in clinical practice using the global pharmacovigilance database. The database included spontaneously reported adverse events and data collected via solicited reporting in patients treated with nintedanib from 15 October 2014 to 15 October 2018. Advers… Show more

Help me understand this report

Search citation statements

Order By: Relevance

Paper Sections

Select...
5

Citation Types

5
33
0
1

Year Published

2021
2021
2024
2024

Publication Types

Select...
5

Relationship

0
5

Authors

Journals

citations
Cited by 28 publications
(39 citation statements)
references
References 39 publications
5
33
0
1
Order By: Relevance
“…In INSTAGE, nintedanib had a similar AE profile to that in the INPULSIS trials in patients with milder disease (albeit with a higher frequency of serious AEs) and AEs led to permanent discontinuation of nintedanib in 19% of patients who received nintedanib plus placebo [34]. Global pharmacovigilance data for nintedanib in the treatment of IPF collected over 4 years (estimated cumulative exposure to nintedanib of 60,107 PY) were consistent with the safety profile established in clinical trials [55].…”
Section: Tolerability Of Nintedanibsupporting
confidence: 62%
See 4 more Smart Citations
“…In INSTAGE, nintedanib had a similar AE profile to that in the INPULSIS trials in patients with milder disease (albeit with a higher frequency of serious AEs) and AEs led to permanent discontinuation of nintedanib in 19% of patients who received nintedanib plus placebo [34]. Global pharmacovigilance data for nintedanib in the treatment of IPF collected over 4 years (estimated cumulative exposure to nintedanib of 60,107 PY) were consistent with the safety profile established in clinical trials [55].…”
Section: Tolerability Of Nintedanibsupporting
confidence: 62%
“…GI AEs were the most frequently reported AEs in clinical trials and global pharmacovigilance data. In the latter, diarrhoea had an incidence rate of 301.6 events/1000 PY and most events of diarrhoea were non-serious (97%) [ 55 ]. GI perforation was rare, occurring at a rate of 1.0 event/1000 PY [ 55 ].…”
Section: Tolerability Of Nintedanibmentioning
confidence: 99%
See 3 more Smart Citations