Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11110/19:10397510

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30203 - Respiratory systems

Projekt

—

Návaznosti

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Rok uplatnění

2019

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

RESPIRATORY MEDICINE

ISSN

0954-6111

e-ISSN

1532-3064

Svazek periodika

150

Číslo periodika v rámci svazku

04/2019

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

6

Strana od-do

120-125

Kód UT WoS článku

000463627700018

EID výsledku v databázi Scopus

2-s2.0-85062968919