| pubmed-article:20579113 | rdf:type | pubmed:Citation | lld:pubmed |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0025663 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0032105 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0036043 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0015506 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0032893 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0733511 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0205210 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C0205547 | lld:lifeskim |
| pubmed-article:20579113 | lifeskim:mentions | umls-concept:C1815260 | lld:lifeskim |
| pubmed-article:20579113 | pubmed:issue | 6 | lld:pubmed |
| pubmed-article:20579113 | pubmed:dateCreated | 2010-10-26 | lld:pubmed |
| pubmed-article:20579113 | pubmed:abstractText | ? Postauthorization safety surveillance of factor VIII (FVIII) concentrates is essential for assessing rare adverse event incidence. We determined safety and efficacy of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method, (rAHF-PFM)] during routine clinical practice. Subjects with differing haemophilia A severities and medical histories were monitored during 12 months of prophylactic and/or on-demand therapy. Among 408 evaluable subjects, 386 (95%) received excellent/good efficacy ratings for all on-demand assessments; the corresponding number for subjects with previous FVIII inhibitors was 36/41 (88%). Among 276 evaluable subjects receiving prophylaxis continuously in the study, 255 (92%) had excellent/good ratings for all prophylactic assessments; the corresponding number for subjects with previous FVIII inhibitors was 41/46 (89%). Efficacy of surgical prophylaxis was excellent/good in 16/16 evaluable procedures. Among previously treated patients (PTPs) with >50 exposure days (EDs) and FVIII?2%, three (0.75%) developed low-titre inhibitors. Two of these subjects had a positive inhibitor history; thus, the incidence of de novo inhibitor formation in PTPs with FVIII?2% and no inhibitor history was 1/348 (0.29%; 95% CI, 0.01-1.59%). A PTP with moderate haemophilia developed a low-titre inhibitor. High-titre inhibitors were reported in a PTP with mild disease (following surgery), a previously untreated patient (PUP) with moderate disease (following surgery) and a PUP with severe disease. The favourable benefit/risk profile of rAHF-PFM previously documented in prospective clinical trials has been extended to include a broader range of haemophilia patients, many of whom would have been ineligible for registration studies. | lld:pubmed |
| pubmed-article:20579113 | pubmed:language | eng | lld:pubmed |
| pubmed-article:20579113 | pubmed:journal | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:20579113 | pubmed:citationSubset | IM | lld:pubmed |
| pubmed-article:20579113 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:20579113 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:20579113 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:20579113 | pubmed:chemical | http://linkedlifedata.com/r... | lld:pubmed |
| pubmed-article:20579113 | pubmed:status | MEDLINE | lld:pubmed |
| pubmed-article:20579113 | pubmed:month | Nov | lld:pubmed |
| pubmed-article:20579113 | pubmed:issn | 1365-2516 | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:LuxKK | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:RichardsMM | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:GoudemandJJ | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:ValentinoLL | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:OldenburgJJ | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:SpottsGG | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:GajekHH | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:EwensteinBB | lld:pubmed |
| pubmed-article:20579113 | pubmed:author | pubmed-author:KriukovAA | lld:pubmed |
| pubmed-article:20579113 | pubmed:copyrightInfo | © 2010 Blackwell Publishing Ltd. | lld:pubmed |
| pubmed-article:20579113 | pubmed:issnType | Electronic | lld:pubmed |
| pubmed-article:20579113 | pubmed:volume | 16 | lld:pubmed |
| pubmed-article:20579113 | pubmed:owner | NLM | lld:pubmed |
| pubmed-article:20579113 | pubmed:authorsComplete | Y | lld:pubmed |
| pubmed-article:20579113 | pubmed:pagination | 866-77 | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
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| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:meshHeading | pubmed-meshheading:20579113... | lld:pubmed |
| pubmed-article:20579113 | pubmed:year | 2010 | lld:pubmed |
| pubmed-article:20579113 | pubmed:articleTitle | Postauthorization safety surveillance of ADVATE [antihaemophilic factor (recombinant), plasma/albumin-free method] demonstrates efficacy, safety and low-risk for immunogenicity in routine clinical practice. | lld:pubmed |
| pubmed-article:20579113 | pubmed:affiliation | Institute of Experimental Haematology and Transfusion Medicine, University Clinic Bonn, Bonn, Germany. johannes.oldenburg@ukb.uni-bonn.de | lld:pubmed |
| pubmed-article:20579113 | pubmed:publicationType | Journal Article | lld:pubmed |
| pubmed-article:20579113 | pubmed:publicationType | Multicenter Study | lld:pubmed |
