Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00064190%3A_____%2F19%3AN0000063" target="_blank" >RIV/00064190:_____/19:N0000063 - isvavai.cz</a>
Alternative codes found
RIV/00216208:11110/19:10397510
Result on the web
<a href="http://dx.doi.org/10.1016/j.rmed.2019.02.021" target="_blank" >http://dx.doi.org/10.1016/j.rmed.2019.02.021</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1016/j.rmed.2019.02.021" target="_blank" >10.1016/j.rmed.2019.02.021</a>
Alternative languages
Result language
angličtina
Original language name
Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
Original language description
Background: Idiopathic pulmonary fibrosis (IPF) is a fatal interstitial lung disease characterized by irreversible loss of lung function and an unpredictable course of disease progression. Methods: The safety data for patients with IPF who received placebo in 6 clinical trials were pooled to examine the categories and frequencies of serious adverse events (SAEs) in this population. Results: In 1082 patients with IPF who received placebo, 673 SAEs were reported. Of these, 93 SAEs resulted in death (8.6% of patients). Respiratory-related conditions were the most frequently reported SAE (225 events, 16.33 per 100 patient-exposure years [PEY]), followed by infections and infestations (136 events, 9.87 per 100 PEY) and cardiac disorders (79 events, 5.73 per 100 PEY); these categories also had the most fatal outcomes (60, 10, and 10 deaths, respectively). The most frequently reported fatal respiratory-related SAEs were IPF and respiratory failure (38 and 11 patients, respectively), and the most frequently reported fatal infections and infestations and cardiac disorders were pneumonia (5 patients) and myocardial infarction (3 patients), respectively. Conclusions: This pooled analysis has value as a comparator for safety in future studies of IPF and provides insights in the natural evolution of both IPF and common comorbidities.
Czech name
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Czech description
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Classification
Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
30203 - Respiratory systems
Result continuities
Project
—
Continuities
N - Vyzkumna aktivita podporovana z neverejnych zdroju
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Name of the periodical
RESPIRATORY MEDICINE
ISSN
0954-6111
e-ISSN
1532-3064
Volume of the periodical
150
Issue of the periodical within the volume
04/2019
Country of publishing house
GB - UNITED KINGDOM
Number of pages
6
Pages from-to
120-125
UT code for WoS article
000463627700018
EID of the result in the Scopus database
2-s2.0-85062968919