About: Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries

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About: Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries Goto Sponge NotDistinct Permalink

An Entity of Type : http://linked.opendata.cz/ontology/domain/vavai/Vysledek, within Data Space : linked.opendata.cz associated with source document(s)

Attributes	Values
rdf:type	skos:Concept http://linked.opendata.cz/ontology/domain/vavai/Vysledek
rdfs:seeAlso	http://dx.doi.org/10.1111/hae.12329
Description	Data regarding on-demand or prophylactic rFVIIa dosing, TE incidence and subsequent BPA dosing after high rFVIIa doses were compiled from multiple sources incorporating safety surveillance. A total of 61 734 rFVIIa doses were reported in 481 patients treated for 3947 bleeds and for 43 135 prophylaxis days. Over half (52%) exceeded 120 μg kg-1, 37% exceeded 160 μg kg-1 and 15% exceeded 240 μg kg-1. Subsequent doses of BPA(s) were administered after 38% of initial and 49% of any rFVIIa dose >240 μg kg-1, and were most frequently administered 24 h after initial (40%) or any (53%) doses >240 μg kg-1. No TEs were reported. The findings of this analysis show that rFVIIa doses >90 μg kg-1 are utilized for 'real-world' treatment of children and adults. When additional BPA was administered following an rFVIIa dose >240 μg kg-1, reported intervals were prolonged, often 24 h. No safety issues were identified in the 61 734 doses analysed. Data regarding on-demand or prophylactic rFVIIa dosing, TE incidence and subsequent BPA dosing after high rFVIIa doses were compiled from multiple sources incorporating safety surveillance. A total of 61 734 rFVIIa doses were reported in 481 patients treated for 3947 bleeds and for 43 135 prophylaxis days. Over half (52%) exceeded 120 μg kg-1, 37% exceeded 160 μg kg-1 and 15% exceeded 240 μg kg-1. Subsequent doses of BPA(s) were administered after 38% of initial and 49% of any rFVIIa dose >240 μg kg-1, and were most frequently administered 24 h after initial (40%) or any (53%) doses >240 μg kg-1. No TEs were reported. The findings of this analysis show that rFVIIa doses >90 μg kg-1 are utilized for 'real-world' treatment of children and adults. When additional BPA was administered following an rFVIIa dose >240 μg kg-1, reported intervals were prolonged, often 24 h. No safety issues were identified in the 61 734 doses analysed. (en)
Title	Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries (en)
skos:prefLabel	Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries Safety of recombinant activated factor VII (rFVIIa) in patients with congenital haemophilia with inhibitors: overall rFVIIa exposure and intervals following high (>240 μg kg-1) rFVIIa doses across clinical trials and registries (en)
skos:notation	RIV/00023736:_____/13:00010964!RIV14-MZ0-00023736
http://linked.open...avai/riv/aktivita	N
http://linked.open...avai/riv/aktivity	N
http://linked.open...iv/cisloPeriodika	1
http://linked.open...vai/riv/dodaniDat	2014
http://linked.open...aciTvurceVysledku	Salaj, Peter
http://linked.open.../riv/druhVysledku	J - Článek v odborném periodiku
http://linked.open...iv/duvernostUdaju	S - Úplné a pravdivé údaje nepodléhající ochraně podle zvláštních právních předpisů
http://linked.open...titaPredkladatele	Ústav hematologie a krevní transfúze
http://linked.open...dnocenehoVysledku	103889
http://linked.open...ai/riv/idVysledku	RIV/00023736:_____/13:00010964
http://linked.open...riv/jazykVysledku	eng - angličtina
http://linked.open.../riv/klicovaSlova	Blood coagulation factor inhibitors; Blood coagulation factors; Factor VIIa; haemophilia A; Haemophilia B; Haemostasis (en)
http://linked.open.../riv/klicoveSlovo	Blood coagulation factor inhibitors Blood coagulation factors Factor VIIa Haemophilia B Haemostasis haemophilia A
http://linked.open...odStatuVydavatele	GB - Spojené království Velké Británie a Severního Irska
http://linked.open...ontrolniKodProRIV	[F4A88AFAAE05]
http://linked.open...i/riv/nazevZdroje	Haemophilia
http://linked.open...in/vavai/riv/obor	FD
http://linked.open...ichTvurcuVysledku	1 (xsd:int)
http://linked.open...cetTvurcuVysledku	6 (xsd:int)
http://linked.open...UplatneniVysledku	2013
http://linked.open...v/svazekPeriodika	20
http://linked.open...iv/tvurceVysledku	Salaj, Peter Cooper, D. L. Blanchette, V. Gut, R. Z. Neufeld, E. J. Shapiro, A. D.
issn	1351-8216
number of pages	9 (xsd:int)
http://bibframe.org/vocab/doi	10.1111/hae.12329

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