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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

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • 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