Serious adverse events in patients with idiopathic pulmonary fibrosis in the placebo arms of 6 clinical trials
Jazyk angličtina Země Velká Británie, Anglie Médium print-electronic
Typ dokumentu klinické zkoušky, fáze II, klinické zkoušky, fáze III, srovnávací studie, časopisecké články, randomizované kontrolované studie, práce podpořená grantem
PubMed
30961937
DOI
10.1016/j.rmed.2019.02.021
PII: S0954-6111(19)30075-7
Knihovny.cz E-zdroje
- Klíčová slova
- Idiopathic pulmonary fibrosis, Interstitial lung disease, Safety,
- MeSH
- bezpečnost statistika a číselné údaje MeSH
- idiopatická plicní fibróza farmakoterapie epidemiologie mortalita patofyziologie MeSH
- infarkt myokardu epidemiologie MeSH
- infekce epidemiologie MeSH
- intersticiální plicní nemoci epidemiologie mortalita MeSH
- komorbidita MeSH
- lidé středního věku MeSH
- lidé MeSH
- nemoci srdce epidemiologie MeSH
- placebo aplikace a dávkování škodlivé účinky MeSH
- pneumonie epidemiologie MeSH
- progrese nemoci MeSH
- respirační funkční testy metody MeSH
- respirační insuficience epidemiologie MeSH
- senioři MeSH
- Check Tag
- lidé středního věku MeSH
- lidé MeSH
- mužské pohlaví MeSH
- senioři MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- klinické zkoušky, fáze II MeSH
- klinické zkoušky, fáze III MeSH
- práce podpořená grantem MeSH
- randomizované kontrolované studie MeSH
- srovnávací studie MeSH
- Názvy látek
- placebo MeSH
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.
1st Medical Faculty Charles University and Thomayer Hospital Prague Czech Republic
Department of Respiratory Medicine Erasmus MC University Medical Center Rotterdam the Netherlands
F Hoffmann La Roche Ltd Basel Switzerland
Genentech Inc South San Francisco CA USA
Medical University of South Carolina Charleston SC USA
St Elizabeth's Medical Center Boston MA USA
University Hospitals Leuven Leuven Belgium
Citace poskytuje Crossref.org
