id:"swepub:oai:gup.ub.gu.se/52958"
Sökning: id:"swepub:oai:gup.ub.gu.se/52958" > Dornase alfa is wel...
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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 02577naa a2200289 4500 | |
| 001 | oai:gup.ub.gu.se/52958 | |
| 003 | SwePub | |
| 008 | 240910s2007 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://gup.ub.gu.se/publication/529582 URI |
| 024 | 7 | a https://doi.org/10.1002/ppul.206852 DOI |
| 040 | a (SwePub)gu | |
| 041 | a eng | |
| 042 | 9 SwePub | |
| 072 | 7 | a ref2 swepub-contenttype |
| 072 | 7 | a art2 swepub-publicationtype |
| 100 | 1 | a McKenzie, S. G.4 aut |
| 245 | 1 0 | a Dornase alfa is well tolerated: Data from the Epidemiologic Registry of Cystic Fibrosis |
| 264 | c 2007-08-28 | |
| 264 | 1 | b Wiley,c 2007 |
| 520 | a After closure of the Epidemiologic Registry of Cystic Fibrosis (ERCF), a comprehensive safety analysis of dornase alfa was performed. A planned subanalysis focused on children under 5 years old. Reported serious adverse events (SAEs) were assigned a preferred term and ascribed to a specific organ system. Possible serious adverse reactions to dornase alfa (SADRs) were identified by reporting clinics. Twenty-eight of 15,865 SAEs (0.18%), occurring in 26 of 6,829 patients ever treated with dornase alfa (0.38%), and no deaths were reported as possible SADRs: most were typical complications of cystic fibrosis (CF). There was no evidence of any unrecognized risk of treatment. During 24,586 patient-years of follow-up (FU) of ever-treated patients, SAEs (mostly typical respiratory complications of CF) were more frequent on-treatment (0.4999/patient-year; 95% CI 0.4921-0.5076) than off-treatment (0.3889; 0.3787-0.3992). This was likely caused by within-patient prescription bias. During 655 patient-years of FU in 328 ever-treated patients under 5 years old, SAEs (mostly pulmonary exacerbations of CF) were slightly less frequent during treatment: 0.2911 (0.2367-0.3455) versus 0.3563 (0.3086-0.4040; ns). Results confirm the safety of dornase alfa in CF patients of all ages. Children under 5 years old tolerate dornase alfa at least as well as older patients. Pediatr Pulmonol. 2007; 42:928-937. (c) 2007 Wiley-Liss, Inc. | |
| 700 | 1 | a Chowdhury, S.4 aut |
| 700 | 1 | a Strandvik, Birgitta,d 1938u Gothenburg University,Göteborgs universitet,Institutionen för kliniska vetenskaper,Institute of Clinical Sciences4 aut0 (Swepub:gu)xstrab |
| 700 | 1 | a Hodson, M. E.4 aut |
| 710 | 2 | a Göteborgs universitetb Institutionen för kliniska vetenskaper4 org |
| 773 | 0 | t Pediatr Pulmonold : Wileyg 42:10, s. 928-37q 42:10<928-37x 8755-6863 |
| 856 | 4 8 | u https://gup.ub.gu.se/publication/52958 |
| 856 | 4 8 | u https://doi.org/10.1002/ppul.20685 |
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