Matches in SemOpenAlex for { <https://semopenalex.org/work/W4312710019> ?p ?o ?g. }
Showing items 1 to 66 of
66
with 100 items per page.
- W4312710019 abstract "<b>Introduction:</b> Budesonide-formoterol (bud-form) fixed-dose is formally indicated for COPD and Ashtma. The aim of this study is to review the post-marketing safety based on pharmacovigilance data of a product available in Brazil (Alenia®). <b>Methods and Results:</b> The defined daily dose (DDD) is estimated at 2 capsules per day per patient and the average duration of treatment is 1.857 days, thus, each exposed patient was considered to being exposed to 3.714 capsules during the therapy. We estimate that approximately 683.250 patients were exposed in this period with 0,26% (1.750) reporting adverse events. 3.951 adverse events were reported in 1.750 patients who used the 12/400 mcg presentation from 2013 to 2022 when an approximate amount of 2,5 billion capsules of bud-form (Alenia®) 12/400 mcg were commercialized in Brazil. The total incidence of reported events was 0,58%, classified as uncommon according to local legislation that divides it into serious and non-serious events. A serious event is defined as “any undesirable medical event, in any dosing, that results in death, risk of death, hospitalization or extended one, significant or persistent disability and congenital anomaly. On the other hand, non-serious adverse events are observed in patients that don’t match serious event criteria for not presenting a risk to the patient. Therefore, only 284 events were reported as serious according to individual evaluation process, data that corresponds to 7% of total reported events. <b>Conclusion:</b> Considering this analysis, we can conclude that the use of a wide-spread molecule, such as budesonide-formoterol combination in Brazil, was associated with a few occurrence of adverse events and, when reported, were mostly non-serious events." @default.
- W4312710019 created "2023-01-05" @default.
- W4312710019 creator A5000108851 @default.
- W4312710019 creator A5001980650 @default.
- W4312710019 creator A5002164913 @default.
- W4312710019 creator A5025212961 @default.
- W4312710019 creator A5054654174 @default.
- W4312710019 creator A5087247369 @default.
- W4312710019 creator A5091407857 @default.
- W4312710019 date "2022-09-04" @default.
- W4312710019 modified "2023-09-27" @default.
- W4312710019 title "Pharmacovigilance in Brazil: safety of budesonide-formoterol" @default.
- W4312710019 doi "https://doi.org/10.1183/13993003.congress-2022.2282" @default.
- W4312710019 hasPublicationYear "2022" @default.
- W4312710019 type Work @default.
- W4312710019 citedByCount "0" @default.
- W4312710019 crossrefType "proceedings-article" @default.
- W4312710019 hasAuthorship W4312710019A5000108851 @default.
- W4312710019 hasAuthorship W4312710019A5001980650 @default.
- W4312710019 hasAuthorship W4312710019A5002164913 @default.
- W4312710019 hasAuthorship W4312710019A5025212961 @default.
- W4312710019 hasAuthorship W4312710019A5054654174 @default.
- W4312710019 hasAuthorship W4312710019A5087247369 @default.
- W4312710019 hasAuthorship W4312710019A5091407857 @default.
- W4312710019 hasConcept C120665830 @default.
- W4312710019 hasConcept C121332964 @default.
- W4312710019 hasConcept C126322002 @default.
- W4312710019 hasConcept C194828623 @default.
- W4312710019 hasConcept C197934379 @default.
- W4312710019 hasConcept C2776042228 @default.
- W4312710019 hasConcept C2776136866 @default.
- W4312710019 hasConcept C2776780178 @default.
- W4312710019 hasConcept C2777288759 @default.
- W4312710019 hasConcept C2779871671 @default.
- W4312710019 hasConcept C57658597 @default.
- W4312710019 hasConcept C61511704 @default.
- W4312710019 hasConcept C71924100 @default.
- W4312710019 hasConceptScore W4312710019C120665830 @default.
- W4312710019 hasConceptScore W4312710019C121332964 @default.
- W4312710019 hasConceptScore W4312710019C126322002 @default.
- W4312710019 hasConceptScore W4312710019C194828623 @default.
- W4312710019 hasConceptScore W4312710019C197934379 @default.
- W4312710019 hasConceptScore W4312710019C2776042228 @default.
- W4312710019 hasConceptScore W4312710019C2776136866 @default.
- W4312710019 hasConceptScore W4312710019C2776780178 @default.
- W4312710019 hasConceptScore W4312710019C2777288759 @default.
- W4312710019 hasConceptScore W4312710019C2779871671 @default.
- W4312710019 hasConceptScore W4312710019C57658597 @default.
- W4312710019 hasConceptScore W4312710019C61511704 @default.
- W4312710019 hasConceptScore W4312710019C71924100 @default.
- W4312710019 hasLocation W43127100191 @default.
- W4312710019 hasOpenAccess W4312710019 @default.
- W4312710019 hasPrimaryLocation W43127100191 @default.
- W4312710019 hasRelatedWork W111923798 @default.
- W4312710019 hasRelatedWork W132708973 @default.
- W4312710019 hasRelatedWork W1515375981 @default.
- W4312710019 hasRelatedWork W1989310269 @default.
- W4312710019 hasRelatedWork W2005698822 @default.
- W4312710019 hasRelatedWork W2054811603 @default.
- W4312710019 hasRelatedWork W2103632605 @default.
- W4312710019 hasRelatedWork W2130168077 @default.
- W4312710019 hasRelatedWork W4250355605 @default.
- W4312710019 hasRelatedWork W4312710019 @default.
- W4312710019 isParatext "false" @default.
- W4312710019 isRetracted "false" @default.
- W4312710019 workType "article" @default.