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fondaparinux

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Description

Fondaparinux: Synthetic pentasaccharide that mediates the interaction of HEPARIN with ANTITHROMBINS and inhibits FACTOR Xa; it is used for prevention of VENOUS THROMBOEMBOLISM after surgery. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

fondaparinux : A synthetic pentasaccharide which, apart from the O-methyl group at the reducing end of the molecule, consists of monomeric sugar units which are identical to a sequence of five monomeric sugar units that can be isolated after either chemical or enzymatic cleavage of the polymeric glycosaminoglycans heparin and heparan sulfate. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5282448
CHEMBL ID1201202
CHEBI ID61033
SCHEMBL ID17655218
MeSH IDM0403648

Synonyms (27)

Synonym
CHEBI:61033 ,
CHEMBL1201202
methyl 2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1->4)-beta-d-glucopyranuronosyl-(1->4)-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1->4)-2-o-sulfo-alpha-l-idopyranuronosyl-(1->4)-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-g
104993-28-4
trisulfoamino heparin pentasaccharide
sr 90107
alpha-d-glucopyranoside, methyl o-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-beta-d-glucopyranuronosyl-(1-4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-4)-2-deoxy-2-(su
DB00569
natural heparin pentasaccharide
fondaparinux
hsdb 7845
j177fow5jl ,
unii-j177fow5jl
fondaparinux [vandf]
fondaparinux [who-dd]
fondaparinux [hsdb]
gtpl6819
fondaparin
DTXSID10146903 ,
SCHEMBL17655218
Q27077698
bdbm50511579
a-d-glucopyranoside, methylo-2-deoxy-6-o-sulfo-2-(sulfoamino)-a-d-glucopyranosyl-(14)-o-b-d-glucopyranuronosyl-(14)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-a-d-glucopyranosyl-(14)-o-2-o-sulfo-a-l-idopyranuronosyl-(14)-2-deoxy-2-(sulfoamino)-, 6-(hydrogen
(2s,3s,4r,5r,6r)-6-[(2r,3r,4r,5r,6r)-6-[(2r,3s,4s,5r,6r)-2-carboxy-4-hydroxy-6-[(2r,3s,4r,5r,6s)-4-hydroxy-6-methoxy-5-(sulfoamino)-2-(sulfooxymethyl)oxan-3-yl]oxy-5-sulfooxyoxan-3-yl]oxy-5-(sulfoamino)-4-sulfooxy-2-(sulfooxymethyl)oxan-3-yl]oxy-3-[(2r,3r
EN300-19769274
methyl-o-2-deoxy-6-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-->4)-o-beta-d-glucopyra-nuronosyl-(1-->4)-o-2-deoxy-3,6-di-o-sulfo-2-(sulfoamino)-alpha-d-glucopyranosyl-(1-->4)-o-2-o-sulfo-alpha-l-idopyranuronosyl-(1-->4)-2-deoxy-6-o-sulfo-2-(sulfoami
dtxcid9069394

Research Excerpts

Overview

Fondaparinux sodium is a novel antithrombotic agent, the first of a new class of selective factor Xa inhibitors. It is approved for the prevention and treatment of venous thromboembolic events, that is, deep vein thrombosis, pulmonary embolism, and superficial veins.

ExcerptReferenceRelevance
"Fondaparinux sodium is a novel antithrombotic agent, the first of a new class of selective factor Xa inhibitors. "( Fondaparinux sodium mechanism of action: identification of specific binding to purified and human plasma-derived proteins.
Claviés, MC; Donat, F; Necciari, J; Paolucci, F, 2002
)
3.2
"Fondaparinux sodium is a chemically synthesized selective factor Xa inhibitor approved for the prevention and treatment of venous thromboembolic events, that is, deep vein thrombosis, pulmonary embolism, and superficial vein thrombosis, in acutely ill (including those affected by COVID-19 or cancer patients) and those undergoing surgeries. "( Fondaparinux Sodium: Recent Advances in the Management of Thrombosis.
Bauersachs, RM,
)
3.02
"Fondaparinux is a synthetic anticoagulant that inhibits thrombosis by suppressing factor Xa. "( Occurrence rates and risk factors of in-hospital venous thromboembolism, major bleeding, and death in patients receiving fondaparinux after orthopedic surgery or trauma surgery.
Ding, Y; Han, B; Liu, R; Nie, M; Wang, H; Yuan, B; Zhao, M, 2023
)
2.56
"Fondaparinux (FPX) is a synthetic pentasaccharide that binds to antithrombin (AT) and selectively inhibits factor (F) Xa and other upstream coagulation proteases but not thrombin (T)."( Fondaparinux pentasaccharide reduces sepsis coagulopathy and promotes survival in the baboon model of Escherichia coli sepsis.
Chaaban, H; Esmon, CT; Georgescu, C; Keshari, RS; Lupu, C; Lupu, F; McCarty, OJT; Popescu, NI; Silasi, R, 2020
)
2.72
"Fondaparinux sodium is a synthetic pentasaccharide representing the high affinity antithrombin III binding site in heparin. "( Extended Physicochemical Characterization of the Synthetic Anticoagulant Pentasaccharide Fondaparinux Sodium by Quantitative NMR and Single Crystal X-ray Analysis.
Funke, C; Kaspersen, F; Kellenbach, E; Kooijman, H; Leika, A; Lunenburg, M; Üstün, B; Wildt, W, 2017
)
2.12
"Fondaparinux is a synthetic heparin pentasaccharide with a sequence identical to that found in anticoagulant heparin. "( The clinical use of Fondaparinux: A synthetic heparin pentasaccharide.
Pan, N; Tan, L; Zhang, L; Zhang, M; Zhang, Y, 2019
)
2.28
"Fondaparinux (Arixtra®) is a fully synthetic pentasaccharide which acts like a heparin but has an increased half life."( [From heparin to apixaban: anticoagulants cut both ways?].
Bock, F; Hartung, K; Isermann, B; Meyer, F, 2014
)
1.12
"Fondaparinux is an alternative to low-molecular-weight heparins (LMWH) for thromboprophylaxis in various clinical settings (major orthopedic surgery of the lower limbs, major abdominal surgery, immobilized medical patients at high risk of VTE), as well as for the treatment of VTE (deep venous thrombosis, pulmonary embolism). "( PK evaluation of fondaparinux sodium for the treatment of thrombosis.
Bertoletti, L; Delavenne, X; Frappé, P; Laporte, S; Mismetti, P; Zufferey, P, 2014
)
2.18
"Fondaparinux is a factor Xa-inhibitor that is not FDA-approved for this condition, but preliminary experience in HIT patients has been reported in the literature."( Fondaparinux as a safe alternative for managing heparin-induced thrombocytopenia in postoperative cardiac surgery patients.
Cegarra-Sanmartín, V; Cueva, LF; Galán-Serrano, J; González-Rodríguez, R; Moral-García, MV; Paniagua-Iglesias, P; Santamaría-Ortiz, A, 2014
)
2.57
"Fondaparinux is an antithrombin-dependent factor Xa inhibitor that is used for thromboprophylaxis of patients undergoing hip fracture surgery, hip or knee replacement, or abdominal surgery. "( Thromboprophylaxis with fondaparinux in high-risk postoperative patients with renal insufficiency.
Cohen-Wolkowiez, M; Fry, C; Gonzalez, D; Hester, W; Inman, BA; Ortel, TL, 2014
)
2.15
"Fondaparinux is an alternative to low molecular weight heparin (LMWH) for non-ST-elevation myocardial infarction (NSTEMI) with levels of recommendation that differ according to guidelines. "( Impact of fondaparinux versus enoxaparin on in-hospital bleeding and 1-year death in non-ST-segment elevation myocardial infarction. FAST-MI (French Registry of Acute ST-elevation and non-ST-elevation Myocardial Infarction) 2010.
Bonnefoy-Cudraz, E; Collet, JP; Coste, P; Danchin, N; Ennezat, PV; Puymirat, E; Richard, P; Roul, G; Schiele, F; Simon, T, 2015
)
2.26
"Fondaparinux assay is a quick and easy method for screening of heparanase inhibitors using recombinant enzyme or bacterial crude extract."( Development of new methods for determining the heparanase enzymatic activity.
Lima, MA; Melo, CM; Nader, HB; Pinhal, MA; Tersariol, IL, 2015
)
1.14
"Fondaparinux is a selective factor Xa inhibitor with little affinity for PF4 and thus less likely to induce an immune response, making fondaparinux a potentially useful drug for the treatment of HIT."( [Successful treatment with fondaparinux in heparin-induced thrombocytopenia and thrombosis].
Pascualini, MF; Seculini Patiño, CE; Tabares, AH, 2015
)
1.44
"Fondaparinux is a synthetic agent able to act on single factors involved in the coagulation network, which could be administered at fixed doses and with a more predictable response."( The safety of fondaparinux sodium for the treatment of venous thromboembolism.
Dentali, F; Mastroiacovo, D; Sala, G, 2016
)
1.52
"Fondaparinux is a synthetic pentasaccharide, which binds to antithrombin, thereby indirectly inhibiting factor Xa. "( New anticoagulants.
Bauer, KA, 2008
)
1.79
"Fondaparinux is a synthetic pentasaccharide with powerful anticoagulant properties, which may also reduce ischemia-reperfusion (I/R) injury in vivo. "( The synthetic pentasaccharide fondaparinux prevents coronary microvascular injury and myocardial dysfunction in the ischemic heart.
Asseman, P; Decoster, B; Lancel, S; Marechal, X; Montaigne, D; Neviere, R, 2008
)
2.08
"Fondaparinux is a more cost-effective antithrombotic agent than enoxaparin in non-ST-elevation acute coronary syndrome. "( Fondaparinux versus Enoxaparin in non-ST-elevation acute coronary syndromes: short-term cost and long-term cost-effectiveness using data from the Fifth Organization to Assess Strategies in Acute Ischemic Syndromes Investigators (OASIS-5) trial.
Bakhai, A; Flather, M; Lozano-Ortega, G; Mehta, SR; Ormanidhi, O; Palmer, S; Sambrook, J; Sculpher, MJ; Steg, PG; Weintraub, W, 2009
)
3.24
"Fondaparinux is an antithrombotic agent with unique properties that may offer benefit to patients beyond the current approved indications. "( Prescription of fondaparinux in hospitalised patients.
Baroletti, S; Fanikos, J; Goldhaber, SZ; Labreche, M; Niles, M, 2009
)
2.14
"Fondaparinux is a synthetic pentasaccharide belonging to a new group of anticoagulants that inhibit thrombin formation by inhibiting Factor Xa, which is located at the crossing of both the intrinsic and extrinsic pathways. "( Fondaparinux: an overview.
Banerjee, P; Goyal, D; Lip, GY; Nadar, SK; Shantsila, E, 2009
)
3.24
"Fondaparinux is a synthetic pentasaccharide that binds to antithrombin and potentiates inhibition of factor Xa."( Fondaparinux for the treatment of acute heparin-induced thrombocytopenia: a single-center experience.
Grouzi, E; Kyriakou, E; Panagou, I; Spiliotopoulou, I, 2010
)
2.52
"Fondaparinux is an effective and safe alternative."( Extended prophylaxis of venous thromboembolism with fondaparinux in patients undergoing major orthopaedic surgery in Italy: a cost-effectiveness analysis.
Ageno, W; Capri, S; Imberti, D; Moia, M; Palareti, G; Piovella, F; Scannapieco, G, 2010
)
1.33
"Fondaparinux is a synthetic pentasaccharide which specifically targets factor Xa of the coagulation cascade."( Fondaparinux in acute coronary syndromes.
Chaturvedi, V; Karthikeyan, G, 2009
)
2.52
"Fondaparinux is a synthetic antithrombotic agent with specific anti-factor Xa activity. "( Population pharmacokinetics of fondaparinux administered at prophylactic doses after major orthopaedic surgery in everyday practice.
Baylot, D; Borg, JY; Delavenne, X; Deygas, B; Fontenay, M; Laporte, S; Mismetti, P; Nguyen, P; Zufferey, P, 2010
)
2.09
"Fondaparinux is a parenteral factor Xa inhibitor used for venous thromboembolism prevention and treatment."( Successful use of fondaparinux in a patient with a mechanical heart valve replacement and a history of heparin-induced thrombocytopenia.
Corbett, TL; Elher, KS; Garwood, CL, 2010
)
1.42
"Fondaparinux (Arixtra) is an anticoagulant that selectively inhibits activated factor X, thereby interrupting the blood coagulation cascade. "( Fondaparinux: a pharmacoeconomic review of its use in the management of non-ST-segment elevation acute coronary syndrome.
Lyseng-Williamson, KA; McKeage, K, 2010
)
3.25
"Fondaparinux is an agent of choice for the prevention and initial treatment of venous thromboembolism (VTE) as well as myocardial infarction. "( Development and in vivo bioavailability study of an oral fondaparinux delivery system.
Bernkop-Schnürch, A; Klima, G; Leithner, K; Perera, G; Vetter, A, 2010
)
2.05
"Fondaparinux (Arixtra) is an antithrombin (AT)-dependent synthetic inhibitor of factor Xa (FXa). "( Functionality of fondaparinux (pentasaccharide) depends on clinical antithrombin levels.
Fareed, J; Hoppensteadt, D; Jeske, WP; Mayuga, M; Samama, MM; Walenga, JM, 2011
)
2.15
"Fondaparinux is an attractive anticoagulant therapy in patients with HIT. "( Fondaparinux (Arixtra(R)), a safe alternative for the treatment of patients with heparin-induced thrombocytopenia?
Badger, NO, 2010
)
3.25
"Fondaparinux appears to be a safe alternative to heparin after CABG and it is feasible to conduct a definitive RCT using CT angiography to evaluate the effect of fondaparinux treatment on graft patency."( Randomized trial of fondaparinux versus heparin to prevent graft failure after coronary artery bypass grafting: the Fonda CABG study.
Eikelboom, JW; Jung, H; Lamy, A; Landry, D; Sheth, T; Sun, JC; Teoh, KH; Warkentin, TE; Yusuf, S, 2011
)
1.41
"Fondaparinux is an approved indirect FXa inhibitor."( In vitro study of the anticoagulant effects of edoxaban and its effect on thrombin generation in comparison to fondaparinux.
Guinet, C; Kunitada, S; Le Flem, L; Mendell, J; Samama, MM, 2012
)
1.31
"Fondaparinux (Arixtra) is a fast-acting selective inhibitor of factor Xa believed to be non-reactive to HIT sera and therefore may be used as prophylaxis for thrombosis in patients with a history of HIT-1 or HIT-2."( Delayed-onset heparin-induced thrombocytopenia type-2 during fondiparinux (Arixtra) therapy.
Cervantes, J; Cervellione, KL; Gintautas, J; Modi, C; Satani, D, 2009
)
1.07
"Fondaparinux is an accepted form of deep venous thrombosis prophylaxis after hip arthroplasty. "( Compartment syndrome due to massive leg hematoma after primary total hip arthroplasty: a previously unreported complication of fondaparinux.
Hannon, MG; Lamont, JG, 2012
)
2.03
"Fondaparinux is an indirect, Factor Xa inhibitor that requires co-administration of another anticoagulant with anti-Factor IIa activity for percutaneous coronary intervention (PCI) per guideline recommendations. "( Bivalirudin versus unfractionated heparin in percutaneous coronary interventions of patients having received initial fondaparinux treatment: a propensity matched study.
Deliargyris, E; Gershlick, A; Hamon, M; Marso, S; Rao, SV; Steg, G; Valgimigli, M; Verheugt, F; Wang, Y, 2012
)
2.03
"Fondaparinux also appears to be a very promising candidate for the treatment of patients with existing VTE."( Factor Xa inhibition in the prevention of venous thromboembolism and treatment of patients with venous thromboembolism.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2002
)
1.04
"Fondaparinux is a promising new antithrombotic agent. "( Fondaparinux (Arixtra): a new anticoagulant.
Giangrande, PL, 2002
)
3.2
"Fondaparinux is a synthetic pentasaccharide that selectively binds to antithrombin III, inducing a conformational change that increases anti-factor Xa activity. "( Fondaparinux: a new antithrombotic agent.
Cheng, JW, 2002
)
3.2
"Fondaparinux is a selective inhibitor of activated factor X."( Fondaparinux sodium.
Reverter, JC, 2002
)
2.48
"Fondaparinux is a synthetic selective inhibitor of factor Xa, which is critically positioned at the start of the common pathway of the coagulation system."( A new antithrombotic strategy, the selective inhibition of coagulation factors, and its importance to the orthopedic specialist.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2002
)
1.04
"Fondaparinux is a completely synthetic pentasaccharide."( Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux).
Gerotziafas, GT; Samama, MM, 2003
)
1.26
"Fondaparinux is a synthetic form of the natural pentasaccharide, its pharmacokinetics allows one s.c."( [Treatment and prevention of venous thromboembolic events: present and future antithrombotic agents].
Drouet, L, 2003
)
1.04
"Fondaparinux is a selective antithrombin-dependent, indirect inhibitor of activated factor Xa. "( Fondaparinux for prevention of venous thromboembolism in major orthopedic surgery.
Lee, G; Tran, AH, 2003
)
3.2
"Fondaparinux is a synthetic selective inhibitor of factor Xa recently approved for thromboprophylaxis after major orthopedic surgery. "( Two sensitive and rapid chromogenic assays of fondaparinux sodium (Arixtra) in human plasma and other biological matrices.
Capdevla, A; Clavies, MC; Donat, F; Frasa, H; Hendriks, Y; Lagrange, F; Nadal, T; Necciari, J; Paolucci, F; Perez, Y; Van Aarle, F; van den Heuvel, M; van Dinther, T, 2003
)
2.02
"Fondaparinux is a synthetic pentasaccharide, which selectively inhibits coagulation factor (F) Xa, and is registered for prevention of venous thromboembolism following hip fracture, hip replacement, and knee replacement surgery. "( Recombinant factor VIIa reverses the in vitro and ex vivo anticoagulant and profibrinolytic effects of fondaparinux.
Adelmeijer, J; Bijsterveld, NR; De Groot, PG; Levi, M; Lisman, T; Meijers, JC; Nieuwenhuis, HK, 2003
)
1.98
"Fondaparinux is a selective inhibitor of factor Xa and has recently received approval for the prophylaxis of venous thromboembolism in TKR patients."( A cost analysis of fondaparinux versus enoxaparin in total knee arthroplasty.
Leslie, RB; Spruill, WJ; Wade, WE,
)
1.18
"Fondaparinux is a synthetic copy of a pentasaccharide sequence in the heparin molecule."( Delayed-type hypersensitivity skin reactions due to heparins and heparinoids. Tolerance of recombinant hirudins and of the new synthetic anticoagulant fondaparinux.
Koch, P, 2003
)
1.24
"Fondaparinux is a synthetic pentasaccharide that selectively inhibits activated clotting factor X. "( A dose-finding study of fondaparinux in patients with non-ST-segment elevation acute coronary syndromes: the Pentasaccharide in Unstable Angina (PENTUA) Study.
Bobbink, IW; Boland, J; Gardien, M; Klootwijk, P; Lensing, AW; Ruzyllo, W; Simoons, ML; Umans, VA; Vahanian, A; Van De Werf, F; Zeymer, U, 2004
)
2.07
"Fondaparinux is an effective and useful alternative to low molecular weight heparins for the prevention of VTE"( Fondaparinux sodium: a review of its use in the prevention of venous thromboembolism following major orthopaedic surgery.
Perry, CM; Reynolds, NA; Scott, LJ, 2004
)
2.49
"Fondaparinux is a welcomed addition to the available antithrombotic options."( Evolving concepts in the treatment of venous thromboembolism: the role of factor Xa inhibitors.
Helgason, CM; Nutescu, EA, 2004
)
1.04
"Fondaparinux is a new synthetic pentasaccharide with a molecular weight of 1.728 Da."( Fondaparinux: a suitable alternative in cases of delayed-type allergy to heparins and semisynthetic heparinoids? A study of 7 cases.
Hausen, BM; Jappe, U; Juschka, U; Krohn, K; Kuner, N, 2004
)
2.49
"Fondaparinux (Arixtra) is a new synthetic selective factor Xa inhibitor."( Effect of fondaparinux on platelet activation in the presence of heparin-dependent antibodies: a blinded comparative multicenter study with unfractionated heparin.
Cariou, R; Chong, BH; Eichler, P; Greinacher, A; Gruel, Y; Herault, JP; Herbert, JM; Kelton, JG; Meuleman, D; Petitou, M; Savi, P; Warkentin, TE, 2005
)
1.45
"Fondaparinux is a novel synthetic antithrombotic that has been evaluated for the prevention of venous thromboembolism (VTE). "( Pharmacoeconomic analysis of fondaparinux versus enoxaparin for the prevention of thromboembolic events in orthopedic surgery patients.
Dranitsaris, G; Ginsberg, JS; Kahn, SR; Martineau, J; Paton, TW; Smith, R; Stumpo, C, 2004
)
2.06
"Fondaparinux is a new antithrombotic drug that specifically inhibits factor Xa."( Effect of low molecular weight heparin (dalteparin) and fondaparinux (Arixtra) on human osteoblasts in vitro.
Handschin, AE; Hoerstrup, SP; Kock, HJ; Trentz, O; Trentz, OA; Wanner, GA, 2005
)
1.3
"Fondaparinux sodium is a new antithrombotic agent that is indicated for prophylaxis of VTE after major orthopedic surgery."( Fondaparinux sodium compared with enoxaparin sodium: a cost-effectiveness analysis.
Bjorvatn, A; Kristiansen, F, 2005
)
2.49
"Fondaparinux is a synthetic pentasaccharide that selectively inhibits factor Xa (FXa) in the coagulation cascade."( The synthetic pentasaccharide fondaparinux reduces coagulation, inflammation and neutrophil accumulation in kidney ischemia-reperfusion injury.
Frank, RD; Holscher, T; Mackman, N; Pawlinski, R; Sato, Y; Schabbauer, G; Tencati, M, 2005
)
1.34
"Fondaparinux is a synthetic factor Xa inhibitor that has been shown to be superior to standard therapies for the prevention of venous thrombosis."( Randomized, blinded trial comparing fondaparinux with unfractionated heparin in patients undergoing contemporary percutaneous coronary intervention: Arixtra Study in Percutaneous Coronary Intervention: a Randomized Evaluation (ASPIRE) Pilot Trial.
Afzal, R; Bassand, JP; Faxon, DP; Fox, KA; Goodhart, DM; Granger, CB; Labinaz, M; Mehta, SR; Natarajan, MK; Peters, RJ; Rush, B; Steg, PG; Tanguay, JF; Velianou, JL; Weitz, JI; Yusuf, S, 2005
)
1.32
"Fondaparinux is a synthetic antithrombotic agent, which specifically binds to antithrombin."( Minimising the risk of heparin-induced osteoporosis during pregnancy.
Evans, J; Hawkins, D, 2005
)
1.05
"Fondaparinux is a novel synthetic heparin pentasaccharide capable of inhibiting factor Xa via the action of antithrombin (AT) but devoid of anti-factor IIa (thrombin) activity."( Fondaparinux: a potential new therapy for HIT.
Kovacs, MJ; Kuo, KH, 2005
)
2.49
"Fondaparinux is a novel antithrombotic agent characterized by specificity for factor Xa and a lack of platelet interaction."( Emerging strategies in the prevention of venous thromboembolism in hospitalized medical patients.
Spyropoulos, AC, 2005
)
1.05
"Fondaparinux is a recently approved five-saccharide synthetic molecule that carries the evolution of heparin further."( Heparin and other rapidly acting anticoagulants.
Hyers, TM, 2005
)
1.05
"Fondaparinux is a synthetic penta-saccharide which may be regarded as an extreme low-molecular-weight heparin with a ratio of anti-factor Xa : anti-factor IIa activity as 1 : 0, and with a promising efficacy/safety profile."( [Is there a difference between low-molecular-weight heparins?].
Eritsland, J, 2005
)
1.05
"Fondaparinux is a synthetic pentasaccharide that is being used increasingly for both treatment and prophylaxis of venous thromboembolism."( Heparins, low-molecular-weight heparins, and pentasaccharides.
Ansell, JE; Dinwoodey, DL, 2006
)
1.06
"Fondaparinux is a synthetic pentasaccharide that selectively inhibits factor Xa (FXa) in an antithrombin-dependent fashion. "( A non-anticoagulant synthetic pentasaccharide reduces inflammation in a murine model of kidney ischemia-reperfusion injury.
Frank, RD; Holscher, T; Mackman, N; Pawlinski, R; Schabbauer, G; Tencati, M; Weitz, JI, 2006
)
1.78
"Fondaparinux is a synthetic pentasaccharide consisting of the minimal sequence of heparin which interacts with antithrombin (AT). "( Clot structure modification by fondaparinux and consequence on fibrinolysis: a new mechanism of antithrombotic activity.
Kierzek, G; Mirshahi, P; Mirshahi, S; Mishal, Z; Sebaoun, D; Simoneau, G; Soria, C; Soria, J; Vannier, JP; Varin, R; Yvonne Borg, J, 2007
)
2.07
"Fondaparinux is a synthetic selective Factor Xa inhibitor with a high efficacy and good safety, in terms of bleeding risk, in the prevention and treatment of venous thromboembolism, and in the treatment of non-ST elevation acute coronary syndromes (OASIS-5)."( Fondaparinux in the management of patients with ST-elevation acute myocardial infarction.
Turpie, AG, 2006
)
2.5
"Fondaparinux is a synthetic, five-saccharide chain, AT-dependent, anti-FXa agent. "( Fondaparinux: pharmacology and clinical experience in cardiovascular medicine.
Lettino, M; Toschi, V, 2007
)
3.23
"Fondaparinux proved to be a potent anticoagulant with a favourable benefit-to-risk ratio in the prevention of VTE in these study patients."( Fondaparinux prevents venous thromboembolism after joint replacement surgery in Japanese patients.
Fuji, T; Fujita, S; Ochi, T, 2008
)
2.51
"Fondaparinux is a new anticoagulant that interacts with antithrombin III and activated coagulation factor X resulting in an inhibition of the coagulation system. "( Monitoring fondaparinux with the Sonoclot.
Engström, M; Nilsson, CU, 2007
)
2.17
"Fondaparinux is a synthetic pentasaccharide that inhibits thrombin formation and thrombus development via selective antithrombin mediated inhibition of factor Xa. "( Fondaparinux: use in thromboprophylaxis of acute medical patients.
Dhillon, S; Plosker, GL, 2008
)
3.23
"Fondaparinux is a relative new pharmacological agent that selectively binds to antithrombin, and represents a new class of synthetic selective inhibitors of activated factor X."( Fondaparinux for the prevention or treatment of venous thromboembolism related to lower limb trauma: evidence today.
Giannoudis, PV; Kanakaris, NK; Nikolaou, VS; Tosounidis, T, 2008
)
2.51
"Fondaparinux is a synthetic polysaccharide that selectively binds to antithrombin, the primary endogenous regulator of blood coagulation."( Fondaparinux versus enoxaparin for the prevention of venous thromboembolism.
Doggrell, SA, 2002
)
2.48

Effects

Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term. The drug has a linear pharmacokinetic profile allowing once-daily subcutaneous administration.

Fondaparinux has been evaluated in a large population of patients presenting with a SVT. It has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest it is more cost effective than enoxaparin.

ExcerptReferenceRelevance
"Fondaparinux has a diminished risk of HIT."( [From heparin to apixaban: anticoagulants cut both ways?].
Bock, F; Hartung, K; Isermann, B; Meyer, F, 2014
)
1.12
"Fondaparinux has an increased bleeding risk in patients with a CrCl ≤ 50 mL/min and is contraindicated if CrCl < 30 mL/min. "( Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.
An, G; Antigua, A; Bushwitz, J; Cope, J; Patel, A; Zumberg, M, 2015
)
2.13
"Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term."( Spotlight on fondaparinux sodium in acute coronary syndromes.
Blick, SK; Orman, JS; Scott, LJ; Wagstaff, AJ, 2008
)
1.44
"Fondaparinux has a low allergenic potential. "( Low allergenic potential with fondaparinux: results of a prospective investigation.
Boehncke, WH; Garbaraviciene, J; Hecking, C; Kaufmann, R; Kroll, H; Lindhoff-Last, E; Ludwig, RJ; Marzi, I; Scheuermann, J; Schindewolf, M; Wolter, M, 2010
)
2.09
"Fondaparinux has a favourable efficacy-safety profile but if major bleeding occurs, reversal of antithrombotic treatment is challenging. "( Use of recombinant factor VIIa (NovoSeven(®)) in 8 patients with ongoing life-threatening bleeding treated with fondaparinux.
Bernard, Y; Briand, F; Chopard, R; Descotes-Genon, V; Ecarnot, F; Guignier, A; Janin, S; Luporsi, P; Meneveau, N; Racadot, E; Schiele, F; Séronde, MF, 2011
)
2.02
"Fondaparinux has a highly favorable pharmacokinetic profile; four large phase 3 trials comparing subcutaneous fondaparinux 2.5 mg once daily with the low molecular weight heparin (LMWH) enoxaparin in doses approved by regulatory bodies showed that fondaparinux reduced the overall risk of VTE in major orthopedic surgery by > 50% without increasing clinically relevant bleeding."( Factor Xa inhibition in the prevention of venous thromboembolism and treatment of patients with venous thromboembolism.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2002
)
1.04
"Fondaparinux has a linear pharmacokinetic profile allowing once-daily subcutaneous administration."( Fondaparinux, the first selective factor Xa inhibitor.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2003
)
2.48
"Fondaparinux has a half-life compatible with once-a-day administration; modification of its structure (idraparinux) has led to more stable binding with antithrombin and to an increase in its half-life to allow once-a-week administration."( New trends in anticoagulant therapy.
Iliceto, S; Pegoraro, C; Pengo, V, 2004
)
1.04
"Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term."( Fondaparinux sodium: a review of its use in the management of acute coronary syndromes.
Blick, SK; Orman, JS; Scott, LJ; Wagstaff, AJ, 2008
)
2.51
"Fondaparinux has been also successfully used in HIT."( Heparin-induced thrombocytopenia treated with fondaparinux: single center experience.
Dulicek, P; Fiedlerova, Z; Hirmerova, J; Ivanova, E; Kostal, M; Sadilek, P, 2020
)
1.54
"Fondaparinux has been identified as a useful alternative in such patients; here we present the first two documented cases in Australia and a literature review."( Non-immediate heparin and heparinoid cutaneous allergic reactions: a role for fondaparinux.
Ekstrom, C; Lucas, M; Tan, E; Thompson, G, 2018
)
1.43
"Fondaparinux has been shown to be superior to low molecular weight heparin in preventing deep vein thrombosis."( The clinical use of Fondaparinux: A synthetic heparin pentasaccharide.
Pan, N; Tan, L; Zhang, L; Zhang, M; Zhang, Y, 2019
)
1.56
"Fondaparinux has a diminished risk of HIT."( [From heparin to apixaban: anticoagulants cut both ways?].
Bock, F; Hartung, K; Isermann, B; Meyer, F, 2014
)
1.12
"Fondaparinux has an increased bleeding risk in patients with a CrCl ≤ 50 mL/min and is contraindicated if CrCl < 30 mL/min. "( Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.
An, G; Antigua, A; Bushwitz, J; Cope, J; Patel, A; Zumberg, M, 2015
)
2.13
"Fondaparinux has similar effectiveness and safety as argatroban and danaparoid in patients with suspected HIT."( Fondaparinux for the treatment of suspected heparin-induced thrombocytopenia: a propensity score-matched study.
Alahmadi, M; Kang, M; Kovacs, MJ; Lazo-Langner, A; Sawh, S, 2015
)
2.58
"Fondaparinux has been administered alone at 2·5 mg subcutaneously once daily for 24 days during the interruption of warfarin perioperatively."( Prolonged use of fondaparinux for perioperative bridging: a case report of a patient with mechanical heart valve and heparin-induced thrombocytopenia.
Li, DM; Song, XJ; Wang, CT; Wei, M, 2015
)
1.48
"Fondaparinux has been evaluated in a large population of patients presenting with a SVT."( The safety of fondaparinux sodium for the treatment of venous thromboembolism.
Dentali, F; Mastroiacovo, D; Sala, G, 2016
)
1.52
"Fondaparinux has excellent bioavailability when administered subcutaneously, has a longer half-life than LMWHs, and is given once daily by subcutaneous injection in fixed doses, without anticoagulant monitoring."( Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).
Bauer, KA; Donati, MB; Gould, M; Hirsh, J; Samama, MM; Weitz, JI, 2008
)
1.07
"Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term."( Spotlight on fondaparinux sodium in acute coronary syndromes.
Blick, SK; Orman, JS; Scott, LJ; Wagstaff, AJ, 2008
)
1.44
"Fondaparinux has proven its safety by patients over 100 kg."( Severe bleeding secondary to misuse of fondaparinux: a case report.
Bohand, X; Bousquet, A; Le Garlantezec, P; Nielly, H; Perrier, E, 2010
)
1.35
"Fondaparinux has been shown to reduce the risk of major bleeding and 30-day mortality compared with enoxaparin, in patients with non-ST-elevation acute coronary syndrome (NSTE-ACS). "( Cost effectiveness of fondaparinux in non-ST-elevation acute coronary syndrome.
de-Miguel-Balsa, E; Latour-Perez, J, 2009
)
2.11
"Fondaparinux has been used in a small number of patients with HIT and generally appears to be safe."( Heparin-induced thrombocytopenia: when a low platelet count is a mandate for anticoagulation.
Ortel, TL, 2009
)
1.07
"Fondaparinux has recently been approved in patients with acute coronary syndromes. "( Routine use of fondaparinux in acute coronary syndromes: a 2-year multicenter experience.
Bassand, JP; Chopard, R; Descotes-Genon, V; Dutheil, J; Ecarnot, F; Meneveau, N; Schiele, F; Seronde, MF, 2010
)
2.16
"Fondaparinux has minimal affinity for platelet factor 4, making it an alternative agent to unfractionated heparin (UFH) and low-molecular weight heparin (LMWH) and a plausible consideration for patients with a history of HIT."( Successful use of fondaparinux in a patient with a mechanical heart valve replacement and a history of heparin-induced thrombocytopenia.
Corbett, TL; Elher, KS; Garwood, CL, 2010
)
1.42
"Fondaparinux has a low allergenic potential. "( Low allergenic potential with fondaparinux: results of a prospective investigation.
Boehncke, WH; Garbaraviciene, J; Hecking, C; Kaufmann, R; Kroll, H; Lindhoff-Last, E; Ludwig, RJ; Marzi, I; Scheuermann, J; Schindewolf, M; Wolter, M, 2010
)
2.09
"Fondaparinux has a favourable efficacy-safety profile but if major bleeding occurs, reversal of antithrombotic treatment is challenging. "( Use of recombinant factor VIIa (NovoSeven(®)) in 8 patients with ongoing life-threatening bleeding treated with fondaparinux.
Bernard, Y; Briand, F; Chopard, R; Descotes-Genon, V; Ecarnot, F; Guignier, A; Janin, S; Luporsi, P; Meneveau, N; Racadot, E; Schiele, F; Séronde, MF, 2011
)
2.02
"Fondaparinux (FPX) has been used to treat and prevent DVT, however interindividual difference of the drug efficacy exists."( [Risk factor for residual deep vein thrombosis after fondaparinux administration in patients with postoperative replacement arthroplasty].
Enokiya, T; Hasegawa, M; Iwamoto, T; Kawase, R; Muraki, Y; Okuda, M; Sudo, A; Uchida, A, 2012
)
1.35
"Fondaparinux has demonstrated equivalence to enoxaparin in reducing cardiovascular events, but with a lower rate of bleeding in patients using fondaparinux."( Cost-effectiveness of fondaparinux in patients with acute coronary syndrome without ST-segment elevation.
Machado, M; Olimpio, A; Pepe, C; Ramos, R, 2012
)
1.41
"Fondaparinux sodium has not been reported to cause antibody-induced thrombocytopenia."( Fondaparinux sodium.
Goa, KL; Keam, SJ, 2002
)
2.48
"Fondaparinux has a highly favorable pharmacokinetic profile; four large phase 3 trials comparing subcutaneous fondaparinux 2.5 mg once daily with the low molecular weight heparin (LMWH) enoxaparin in doses approved by regulatory bodies showed that fondaparinux reduced the overall risk of VTE in major orthopedic surgery by > 50% without increasing clinically relevant bleeding."( Factor Xa inhibition in the prevention of venous thromboembolism and treatment of patients with venous thromboembolism.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2002
)
1.04
"Fondaparinux has shown efficacy in the prevention of venous thromboembolism in patients undergoing hip or knee replacement surgery. "( Fondaparinux: a new antithrombotic agent.
Cheng, JW, 2002
)
3.2
"Fondaparinux has no effect on coagulation tests and does not bind to platelet factor 4 or promote heparin-induced thrombocytopenia."( Fondaparinux sodium.
Reverter, JC, 2002
)
2.48
"Fondaparinux has demonstrated its efficacy compared to a widely used low-molecular-weight heparin in a number of thromboprophylaxis trials after major orthopedic surgery and is approved for use in this setting."( A new antithrombotic strategy, the selective inhibition of coagulation factors, and its importance to the orthopedic specialist.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2002
)
1.04
"Fondaparinux has nearly complete bioavailability after subcutaneous injection."( Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux).
Gerotziafas, GT; Samama, MM, 2003
)
1.26
"Fondaparinux has a linear pharmacokinetic profile allowing once-daily subcutaneous administration."( Fondaparinux, the first selective factor Xa inhibitor.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2003
)
2.48
"Fondaparinux has been approved for use in thromboprophylaxis after major orthopedic surgery, where it has demonstrated its efficacy compared to a low-molecular-weight heparin."( New pentasaccharides for prophylaxis of deep vein thrombosis: pharmacology.
Bauer, KA, 2003
)
1.04
"Fondaparinux has been recently approved for use in thromboprophylaxis after major orthopedic surgery."( New pentasaccharides for the prophylaxis of venous thromboembolism: clinical studies.
Bauer, KA; Eriksson, BI; Lassen, MR; Turpie, AG, 2003
)
1.04
"Fondaparinux has been extensively investigated in two areas: orthopedic surgery and venous thromboembolism."( Pentasaccharides in the prophylaxis and treatment of venous thromboembolism: a systematic review.
Huisman, MV; Nijkeuter, M, 2004
)
1.04
"Fondaparinux has a half-life compatible with once-a-day administration; modification of its structure (idraparinux) has led to more stable binding with antithrombin and to an increase in its half-life to allow once-a-week administration."( New trends in anticoagulant therapy.
Iliceto, S; Pegoraro, C; Pengo, V, 2004
)
1.04
"Fondaparinux currently has licenses in the UK for thromboprophylaxis and treatment of VTE and a license for the management of acute coronary syndrome is likely to be forthcoming."( Anticoagulation via anti-Factor Xa inhibition.
Hunt, BJ; Wiles, N, 2006
)
1.06
"Fondaparinux has the approval for its introduction into the market as a maximum representative of this group and has begun to be used."( [Deep vein thrombosis: new drugs and future therapeutic perspectives].
Berga Fauria, C; García Vidal, R; Paredero, VM, 2006
)
1.06
"Fondaparinux has a favorable tolerability profile, particularly with regard to the risk of major bleeding, and limited data suggest that it is more cost effective than enoxaparin in the short term."( Fondaparinux sodium: a review of its use in the management of acute coronary syndromes.
Blick, SK; Orman, JS; Scott, LJ; Wagstaff, AJ, 2008
)
2.51
"Fondaparinux has not shown any impairment in vitro."( The effect of anticoagulant pharmacotherapy on fracture healing.
Cockbain, AJ; El Masry, MA; Katonis, P; Lindner, T; Schizas, C; Tsiridis, E, 2008
)
1.07
"Fondaparinux has been shown to be as effective as enoxaparin in the prevention of thrombosis in patients undergoing orthopedic surgery and showed similar results compared to enoxaparin or UFH in patients with deep-vein-thrombosis or pulmonary embolism."( Factor Xa inactivation in acute coronary syndrome.
Barantke, M; Bonnemeier, H, 2008
)
1.07

Actions

Fondaparinux does not inhibit thrombin activity, release tissue factor pathway inhibitor, or possess other properties of heparin such as anti-inflammatory, anti-viral, and anti-angiogenesis.

ExcerptReferenceRelevance
"Fondaparinux does not inhibit thrombin activity, release tissue factor pathway inhibitor, or possess other properties of heparin such as anti-inflammatory, anti-viral, anti-angiogenesis, anti-neoplastic, and anti-metastatic effects though high affinity interactions with a variety of proteases, protease inhibitors, chemokines, cytokines, growth factors, and their respective receptors."( The clinical use of Fondaparinux: A synthetic heparin pentasaccharide.
Pan, N; Tan, L; Zhang, L; Zhang, M; Zhang, Y, 2019
)
1.56
"Fondaparinux did not inhibit osteoblast proliferation in vitro and may reduce the risk of heparin-induced osteoporosis associated with long-term heparin administration."( Effect of low molecular weight heparin (dalteparin) and fondaparinux (Arixtra) on human osteoblasts in vitro.
Handschin, AE; Hoerstrup, SP; Kock, HJ; Trentz, O; Trentz, OA; Wanner, GA, 2005
)
2.02

Treatment

Fondaparinux treatment decreased the thickness of submesothelial fibrotic tissue, and size and number of CD31-positive vessels. Treatment with fondaparinUX resulted in less cost and more AEs averted, hence dominating argatroban.

ExcerptReferenceRelevance
"Fondaparinux treatment decreased the thickness of submesothelial fibrotic tissue, and size and number of CD31-positive vessels."( Tissue factor and factor v involvement in rat peritoneal fibrosis.
Kato, K; Kitamoto, M; Kitamura, H; Liu, N; Mori, N; Nogaki, F; Ono, T; Saito, H; Takeda, T; Uemura, K,
)
0.85
"In fondaparinux (1 μg/ml) treated plasma with normal or lower AT activity effects of Humate-P vs."( Elevated factor VIII enhances thrombin generation in the presence of factor VIII-deficiency, factor XI-deficiency or fondaparinux.
Levy, JH; Molinaro, RJ; Solomon, C; Sreeram, G; Szlam, F; Tanaka, KA, 2011
)
1.09
"Fondaparinux-treated patients with bleeding (>10% haematocrit decrease) and cardiovascular collapse were eligible. "( Use of recombinant factor VIIa (NovoSeven(®)) in 8 patients with ongoing life-threatening bleeding treated with fondaparinux.
Bernard, Y; Briand, F; Chopard, R; Descotes-Genon, V; Ecarnot, F; Guignier, A; Janin, S; Luporsi, P; Meneveau, N; Racadot, E; Schiele, F; Séronde, MF, 2011
)
2.02
"Fondaparinux treatment significantly suppressed urinary protein, glomerular hypertrophy, fibrin deposition, expression of connective tissue growth factor, and ECM proteins deposition together with CD31-positive capillaries."( Roles of coagulation pathway and factor Xa in the progression of diabetic nephropathy in db/db mice.
Bai, F; Makino, T; Mizukami, H; Ono, T; Sumi, A; Yamanaka-Hanada, N, 2011
)
1.09
"The fondaparinux group was treated with IPC and received subcutaneous injections of fondaparinux once daily."( The efficacy of fondaparinux for the prophylaxis of venous thromboembolism after resection for colorectal cancer.
Asao, T; Fujii, F; Kato, T; Kigure, W; Kuwano, H; Morita, H; Suto, T; Tabe, Y; Takaaki, T; Tsutsumi, S; Yajima, R; Yamauchi, H,
)
0.96
"All fondaparinux treated subjects had a complete platelet count recovery, and none experienced a new thromboembolic complication, major bleeding or death by week four."( Fondaparinux for the treatment of patients with acute heparin-induced thrombocytopenia.
Finch, C; Howard, A; Lobo, B; Minhas, S, 2008
)
2.27
"Treatment with fondaparinux resulted in less cost and more AEs averted, hence dominating argatroban."( Cost-effectiveness analysis of alternative anticoagulation in suspected heparin-induced thrombocytopenia.
Baumgartner, I; Bernhard, S; Lenz, A; Muka, T; Salvador, D; Schindewolf, M; Tuleja, A, 2022
)
1.06

Toxicity

Fondaparinux is attributable to fewer adverse events and similar pregnancy outcomes compared with LMWH in patients with recurrent miscarriage. Enoxaparin was found to be as safe as aspirin with respect to bleeding.

ExcerptReferenceRelevance
" Its favorable pharmacokinetic profile and pharmacodynamics allow for safe and effective once-daily dosing in the majority of populations."( Fondaparinux: basic properties and efficacy and safety in venous thromboembolism prophylaxis.
Bauer, KA, 2002
)
1.76
" It has recently been proved to be more effective than, and as safe as, a low-molecular-weight heparin for the prevention of VTE after major orthopaedic surgery."( Current perspectives on the treatment of venous thromboembolism: need for effective, safe and convenient new antithrombotic drugs.
O'Shaughnessy, DF, 2004
)
0.32
"5 mg fondaparinux given for 3 to 5 wk was effective and safe for prevention of venous thromboembolism after major orthopedic surgery."( The safety and efficacy of extended thromboprophylaxis with fondaparinux after major orthopedic surgery of the lower limb with or without a neuraxial or deep peripheral nerve catheter: the EXPERT Study.
Piovella, F; Rosencher, N; Singelyn, FJ; Van Aken, HK; Verheyen, CC, 2007
)
1.1
" Because of their completely different chemical structure, hirudins are a safe alternative for anticoagulation."( The complex clinical picture of side effects to anticoagulation.
Seitz, CS; Trautmann, A, 2010
)
0.36
" There is still the need for larger randomized trials evaluating the true efficacy, appropriate dose, safe duration of treatment, and the true incidence of HIT associated with fondaparinux."( Fondaparinux (Arixtra(R)), a safe alternative for the treatment of patients with heparin-induced thrombocytopenia?
Badger, NO, 2010
)
2
" The recently approved lower prophylactic dose of fondaparinux appears to be a safe and relatively effective strategy in these patients."( Safety and efficacy of low-dose fondaparinux (1.5 mg) for the prevention of venous thromboembolism in acutely ill medical patients with renal impairment: the FONDAIR study.
Ageno, W; Arioli, D; Cuppini, S; Dentali, F; Di Nisio, M; Giorgi Pierfranceschi, M; La Regina, M; Lupia, E; Monzani, V; Noris, P; Pierfranceschi, MG; Ria, L; Riva, N, 2012
)
0.92
" The outcome measurements were the incidence of total VTE, deep venous thrombosis (DVT), symptomatic VTE, pulmonary embolism (PE), major bleeding and any other adverse event."( [Efficacy and safety of fondaparinux versus enoxaparin for preventing venous thromboembolism after major orthopedic surgery: a meta-analysis].
Li, H; Shi, Z; Wang, J; Xiao, J, 2013
)
0.7
" Prophylactic anticoagulation is safe in IBD despite the presence of rectal bleeding on admission."( Predictors and safety of venous thromboembolism prophylaxis among hospitalized inflammatory bowel disease patients.
Nguyen, GC; Ra, G; Ratneswaran, S; Thanabalan, R, 2013
)
0.39
" However, both drugs had some adverse effects."( Safety of fondaparinux versus enoxaparin after TKA in Japanese patients.
Hosaka, K; Ishii, T; Ryu, K; Saito, S; Sumino, T; Suzuki, G; Suzuki, T; Tokuhashi, Y, 2013
)
0.79
" Bleeding, thrombosis and main adverse cardiovascular events (MACE) were compared between the two groups during hospitalization, at week 2 and week 4 after discharge."( [The clinical efficacy and safety of fondaparinux combined with tirofiban hydrochloride in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention].
Chen, Y; Gao, CY; Li, MW; Rao, LX; Zhao, XM; Zhu, ZY, 2013
)
0.66
"5 mg FPX 24 h after colorectal cancer surgery is safe and effective."( Safety of fondaparinux to prevent venous thromboembolism in Japanese patients undergoing colorectal cancer surgery: a multicenter study.
Doki, Y; Fujii, M; Fukuzaki, T; Hasegawa, J; Hata, T; Ikeda, M; Kato, T; Kitani, K; Mizushima, T; Mori, M; Morita, S; Murata, K; Nezu, R; Ohkawa, A; Ohue, M; Okuyama, M; Sekimoto, M; Tamagawa, H; Ueshima, S; Yasui, M, 2014
)
0.8
"5mg daily is safe and effective in preventing VTE without increasing bleeding risk."( Safety of fondaparinux in the prevention of venous thromboembolism in elderly medical patients: results of a single-center, retrospective study.
Ageno, W; Barbi, A; Barillari, G; Bergamo, M; Desideri, M; Guidi, P; Labombarda, A; Pasca, S; Rogato, A; Silvestri, F; Zaramella, M, 2014
)
0.8
" We examined adverse event frequency in hospitalized patients with ischemic stroke who received VTE prophylaxis with fondaparinux versus UFH."( Safety of venous thromboembolism prophylaxis with fondaparinux in ischemic stroke.
Hackett, CT; Kelly, KM; Malhotra, K; Protetch, J; Quigley, MR; Ramanathan, RS; Tayal, AH; Tian, M; Wong, C; Wright, DG, 2015
)
0.88
" Incidences of adverse events were similar (45."( SAfety of Fondaparinux in transoesophageal echocardiography-guided Electric cardioversion of Atrial Fibrillation (SAFE-AF) study: a pilot study.
Aliot, E; Banik, N; Cohen, A; Faber, T; Kropff, S; Le Heuzey, JY; Omran, H; Stellbrink, C, 2015
)
0.82
"FPX is potentially an effective form of VTE prophylaxis; it is safe in terms of both postoperative bleeding and other common complications after colorectal cancer surgery."( Safety and efficacy of fondaparinux for prophylaxis of venous thromboembolism after colorectal cancer resection: a propensity score matched analysis.
Haraguchi, N; Ikeda, M; Ikenaga, M; Miyake, M; Sekimoto, M; Yamaoka, Y, 2015
)
0.73
" The incidence of treatment-emergent adverse events in the safety population was similar between the two groups (944 [36·0%] of 2619 in the rivaroxaban group vs 805 [37·5%] of 2149 in the standard anticoagulation group)."( Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study.
Ageno, W; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Schneider, J; Turpie, AG; van Eickels, M; Zell, E, 2016
)
0.43
" Propensity score-adjusted results confirm that rivaroxaban is a safe and effective alternative to standard anticoagulation therapy in a broad range of patients."( Safety and effectiveness of oral rivaroxaban versus standard anticoagulation for the treatment of symptomatic deep-vein thrombosis (XALIA): an international, prospective, non-interventional study.
Ageno, W; Gebel, M; Haas, S; Kreutz, R; Mantovani, LG; Monje, D; Schneider, J; Turpie, AG; van Eickels, M; Zell, E, 2016
)
0.43
"In this small retrospective review, fondaparinux appeared similarly efficacious and safe compared to DTIs for the treatment of suspected HIT."( Efficacy and Safety of Fondaparinux in Patients With Suspected Heparin-Induced Thrombocytopenia.
Rai, H; Shields, J; Snodgrass, MN, 2016
)
1.02
" The other adverse events were evaluated."( Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial.
Egawa, S; Furuta, A; Hata, K; Ishii, G; Kido, M; Kimura, T; Miki, J; Miki, K; Sasaki, H; Tsuzuki, S; Yamada, H; Yamamoto, T, 2016
)
0.84
" No significant differences were detected in the incidence of postoperative bleeding and the other adverse events between the two groups."( Safety of fondaparinux for prevention of postoperative venous thromboembolism in urological malignancy: A prospective randomized clinical trial.
Egawa, S; Furuta, A; Hata, K; Ishii, G; Kido, M; Kimura, T; Miki, J; Miki, K; Sasaki, H; Tsuzuki, S; Yamada, H; Yamamoto, T, 2016
)
0.84
" However, enoxaparin was found to be as safe as aspirin with respect to bleeding, and fondaparinux was as safe as aspirin for risk of wound complications."( Comparative Effectiveness and Safety of Drug Prophylaxis for Prevention of Venous Thromboembolism After Total Knee Arthroplasty.
Bini, SA; Cafri, G; Cheetham, CT; Chen, Y; Gould, MK; Khatod, M; Paxton, EW; Sluggett, J, 2017
)
0.68
"Anticoagulant treatment is a safe and effective treatment leading to partial or complete recanalization of the portal venous system in 56."( Clinical Impact and Safety of Anticoagulants for Portal Vein Thrombosis in Cirrhosis.
Andreone, P; Grigoras, C; Morelli, M; Pecorelli, A; Pettinari, I; Piscaglia, F; Sparchez, Z; Stefanescu, H; Vukotic, R, 2019
)
0.51
" This meta-analysis aimed to comprehensively compare the pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus LMWH."( Pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus low molecular-weight heparin: A meta-analysis.
Huang, J; Mu, F; Wang, F; Wang, M, 2023
)
1.33
" Data of live birth, abortion, birth weight, fetal growth restriction (FGR), and adverse events were extracted and synthesized."( Pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus low molecular-weight heparin: A meta-analysis.
Huang, J; Mu, F; Wang, F; Wang, M, 2023
)
1.13
" Regarding adverse events, the incidence of ecchymosis (RR = 0."( Pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus low molecular-weight heparin: A meta-analysis.
Huang, J; Mu, F; Wang, F; Wang, M, 2023
)
1.13
"Fondaparinux is attributable to fewer adverse events and similar pregnancy outcomes compared with LMWH in patients with recurrent miscarriage."( Pregnancy outcomes and adverse events in patients with recurrent miscarriage receiving fondaparinux versus low molecular-weight heparin: A meta-analysis.
Huang, J; Mu, F; Wang, F; Wang, M, 2023
)
2.58

Pharmacokinetics

The favourable pharmacokinetic profile of fondaparinux sodium is likely to play an important role in the major advance that the drug represents in the prevention and treatment of thrombotic disorders.

ExcerptReferenceRelevance
"9 ml/min, and the terminal half-life was 17 hours in young volunteers and 21 hours in elderly volunteers."( The pharmacokinetics of fondaparinux sodium in healthy volunteers.
Cariou, R; de Greef, R; Donat, F; Duret, JP; Magnani, H; Necciari, J; Santoni, A, 2002
)
0.62
"The favourable pharmacokinetic profile of fondaparinux sodium is likely to play an important role in the major advance that the drug represents in the prevention and treatment of thrombotic disorders."( The pharmacokinetics of fondaparinux sodium in healthy volunteers.
Cariou, R; de Greef, R; Donat, F; Duret, JP; Magnani, H; Necciari, J; Santoni, A, 2002
)
0.89
" Pharmacokinetic simulations were performed using a population pharmacokinetic model based on data obtained in 756 patients undergoing major orthopedic surgery."( Pharmacokinetic and clinical data supporting the use of fondaparinux 1.5 mg once daily in the prevention of venous thromboembolism in renally impaired patients.
Boyle, DA; Fuji, T; Lensing, AW; Turpie, AG, 2009
)
0.6
" A population pharmacokinetic model of fondaparinux, based on data obtained in patients included in phase II/III trials, has been described."( Population pharmacokinetics of fondaparinux administered at prophylactic doses after major orthopaedic surgery in everyday practice.
Baylot, D; Borg, JY; Delavenne, X; Deygas, B; Fontenay, M; Laporte, S; Mismetti, P; Nguyen, P; Zufferey, P, 2010
)
0.92
" Detailed pharmacokinetic analyses were performed."( FondaKIDS: a prospective pharmacokinetic and safety study of fondaparinux in children between 1 and 18 years of age.
Barbour, A; Khanna, R; Nugent, DJ; O'Brien, SH; Yee, DL; Young, G, 2011
)
0.61
" The monodisperse, (~50 nm), positively charged Fp-cLNCs with high drug loadings demonstrated linear pharmacokinetic profiles of the drug with an increased oral absolute bioavailability (up to ~21%) compatible with therapeutic anticoagulant effect (>0."( Oral fondaparinux: use of lipid nanocapsules as nanocarriers and in vivo pharmacokinetic study.
Benoit, JP; Lagarce, F; Legras, P; Macchi, L; Ramadan, A; Saulnier, P; Tessier-Marteau, A; Thomas, O, 2011
)
0.88
" The bulk of clinical experience with paediatric anticoagulation rests with the first three of these agents, each of which requires higher bodyweight-based dosing for the youngest patients, compared with adults, in order to achieve comparable pharmacodynamic effects, likely related to an inverse correlation between age and bodyweight-normalized clearance of these drugs."( Pharmacokinetics and pharmacodynamics of anticoagulants in paediatric patients.
O'Brien, SH; Yee, DL; Young, G, 2013
)
0.39
" Multivariate analysis and population pharmacokinetic analysis were performed to detect factors that necessitated withdrawal of fondaparinux and individual differences in its pharmacokinetics."( Population pharmacokinetics and pharmacodynamics of fondaparinux in Japanese patients after artificial total knee replacement
.
Hanada, K; Iwa, K; Matsubara, H; Matsuo, T; Shibata, S; Takahashi, H; Takashima, Y; Tsukimura, Y, 2018
)
0.94
" Population pharmacokinetic analysis demonstrated that individual renal function and body weight were significant factors associated with apparent clearance and volume of distribution, respectively."( Population pharmacokinetics and pharmacodynamics of fondaparinux in Japanese patients after artificial total knee replacement
.
Hanada, K; Iwa, K; Matsubara, H; Matsuo, T; Shibata, S; Takahashi, H; Takashima, Y; Tsukimura, Y, 2018
)
0.73

Compound-Compound Interactions

ExcerptReferenceRelevance
"To explore the efficacy and safety of fondaparinux combined with tirofiban in patients with high risk unstable angina (UA) undergoing complex percutaneous coronary intervention (PCI) ."( [The clinical efficacy and safety of fondaparinux combined with tirofiban hydrochloride in patients with acute coronary syndrome undergoing complex percutaneous coronary intervention].
Chen, Y; Gao, CY; Li, MW; Rao, LX; Zhao, XM; Zhu, ZY, 2013
)
0.93

Bioavailability

Fondaparinux is an ideal alternative in conditions where oral anticoagulants are not approved for use or in patients intolerant to low molecular weight heparins (LMWH) The study was to evaluate vasopressor effect on the bioavailability of subcutaneously administered fondaparinUX.

ExcerptReferenceRelevance
" There is nearly complete bioavailability by the sc."( Fondaparinux: a synthetic heparin pentasaccharide as a new antithrombotic agent.
Bick, RL; Fareed, J; Frapaise, FX; Jeske, WP; Samama, MM; Walenga, JM, 2002
)
1.76
" Fondaparinux exhibits complete bioavailability by the subcutaneous route and is rapidly absorbed, reaching its maximum concentration approximately 2 h post dosing."( Fondaparinux, a synthetic pentasaccharide: the first in a new class of antithrombotic agents - the selective factor Xa inhibitors.
Bauer, KA; Hawkins, DW; Herbert, JM; Meuleman, DG; Peters, PC; Petitou, M; van Boeckel, CA, 2002
)
2.67
" Based on studies of the heparin binding site of antithrombin, this novel pentasaccharide has superior pharmacokinetics and bioavailability when compared with LMWH and can be administered once daily."( Treatment of symptomatic venous thromboembolism: improving outcomes.
Büller, HR, 2002
)
0.31
" The drug replicates the sulphated antithrombin-binding pentasaccharide sequence in heparin and induces potent and specific antithrombin-mediated anti-Xa activity with excellent bioavailability and a long circulating half-life of 18 hours that makes it ideal for once-daily subcutaneous dosing."( Heparin pentasaccharide.
Coghlan, DW; Gallus, AS, 2002
)
0.31
" Fondaparinux exhibits a high bioavailability and is convenient to use as it only needs to be given once daily by subcutaneous injection."( Fondaparinux (Arixtra): a new anticoagulant.
Giangrande, PL, 2002
)
2.67
" Phase I trials have shown a 100% bioavailability after subcutaneous (s."( Fondaparinux sodium.
Reverter, JC, 2002
)
1.76
" Fondaparinux has nearly complete bioavailability after subcutaneous injection."( Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux).
Gerotziafas, GT; Samama, MM, 2003
)
1.45
" Inogatran and melagatran have a low bioavailability when given orally, whereas the chemically modified prodrug ximelagatran has a higher bioavailability."( Novel antithrombotic agents: indirect synthetic inhibitors of factor Xa and direct thrombin inhibitors. Evidences from clinical studies.
De Stefano, V; Leone, AM; Leone, G; Rossi, E, 2004
)
0.32
" The drugs are marked by bioavailability approximating 100%, linear dose-dependent pharmacokinetic profile at subcutaneous injection; they do not undergo metabolism and are excreted largely with urine."( [Prevention and treatment of venous thromboses and thromboembolism: pentasaccharides as novel anticoagulants selectively blocking Xe factor, their position and potential (data of the XIX International Congress on Thromboses and Hemostasis)].
Averkov, OV, 2004
)
0.32
" Because of its excellent bioavailability after subcutaneous application once daily independent of body weight (within the range of 50-100 kg) monitoring of the substance is usually not necessary."( [Monitoring anticoagulation by fondaparinux: determination of anti factor Xa-level].
Dämgen-von Brevern, G; Kläffling, C; Lindhoff-Last, E, 2005
)
0.61
" Synthetic, selective, and direct inhibitors to FXa, such as DX-9065a, are highly potent and orally bioavailable antithrombotic agents that have demonstrated an improved side effect profile, probably by allowing sufficient thrombin to remain for platelet activation and normal hemostasis, while preventing pathological thrombus formation."( Factor Xa inhibitors: new anti-thrombotic agents and their characteristics.
Ieko, M; Koike, T; Naito, S; Nakabayashi, T; Tarumi, T; Yoshida, M, 2006
)
0.33
" The complete bioavailability (100%) and elimination half-life of approximately 17 hours allows once-daily administration of fondaparinux."( Fondaparinux: use in thromboprophylaxis of acute medical patients.
Dhillon, S; Plosker, GL, 2008
)
2
" Fondaparinux has excellent bioavailability when administered subcutaneously, has a longer half-life than LMWHs, and is given once daily by subcutaneous injection in fixed doses, without anticoagulant monitoring."( Parenteral anticoagulants: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition).
Bauer, KA; Donati, MB; Gould, M; Hirsh, J; Samama, MM; Weitz, JI, 2008
)
1.26
" However, common ICU conditions may impair the bioavailability of subcutaneously administered agents."( Bioavailability of fondaparinux to critically ill patients.
Cumbo-Nacheli, G; Guzman, JA; Samavati, L, 2011
)
0.7
"The purpose of the study was to evaluate vasopressor effect on the bioavailability of subcutaneously administered fondaparinux."( Bioavailability of fondaparinux to critically ill patients.
Cumbo-Nacheli, G; Guzman, JA; Samavati, L, 2011
)
0.91
"Vasopressor therapy does not appear to affect fondaparinux bioavailability or to reduce anti-factor Xa levels."( Bioavailability of fondaparinux to critically ill patients.
Cumbo-Nacheli, G; Guzman, JA; Samavati, L, 2011
)
0.96
" The monodisperse, (~50 nm), positively charged Fp-cLNCs with high drug loadings demonstrated linear pharmacokinetic profiles of the drug with an increased oral absolute bioavailability (up to ~21%) compatible with therapeutic anticoagulant effect (>0."( Oral fondaparinux: use of lipid nanocapsules as nanocarriers and in vivo pharmacokinetic study.
Benoit, JP; Lagarce, F; Legras, P; Macchi, L; Ramadan, A; Saulnier, P; Tessier-Marteau, A; Thomas, O, 2011
)
0.88
" Fondaparinux exhibits complete bioavailability when administered subcutaneously, has a longer half-life than LMWHs, and is given once daily by subcutaneous injection in fixed doses, without coagulation monitoring."( Parenteral anticoagulants: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Baglin, TP; Garcia, DA; Samama, MM; Weitz, JI, 2012
)
1.29
" In contrast, lower estimates were obtained for volume of distribution and absorption rate constant parameters."( Thromboprophylaxis with fondaparinux in high-risk postoperative patients with renal insufficiency.
Cohen-Wolkowiez, M; Fry, C; Gonzalez, D; Hester, W; Inman, BA; Ortel, TL, 2014
)
0.71
" To overcome the low oral bioavailability of Fpx, a new nanoparticulate carrier has been developed."( Novel self assembling nanoparticles for the oral administration of fondaparinux: synthesis, characterization and in vivo evaluation.
Bianchini, EP; Borgel, D; Bourgaux, C; Couvreur, P; Desmaële, D; Gref, R; Lepeltier, E; Pouget, T; Ralay-Ranaivo, B; Tranchant, JF, 2014
)
0.64
" However, anticoagulants are poorly absorbed by oral route because of their high molecular weight, hydrophilicity and negative charges."( Trends in the development of oral anticoagulants.
Borgel, D; Couvreur, P; Gref, R; Ralay-Ranaivo, B, 2015
)
0.42
"Compared with older agents, low-molecular-weight heparins (LMWH) and fondaparinux offer improved bioavailability and more predictable, dose-independent clearance."( Laboratory Monitoring of Low-Molecular-Weight Heparin and Fondaparinux.
Babin, JL; Traylor, KL; Witt, DM, 2017
)
0.93
" As an anti-factor Xa drug, Fondaparinux has complete bioavailability subcutaneously, instant onset of action, a half-life of 15-20h, and a direct renal excretion without any metabolism."( The clinical use of Fondaparinux: A synthetic heparin pentasaccharide.
Pan, N; Tan, L; Zhang, L; Zhang, M; Zhang, Y, 2019
)
1.13
" Some of the advantages with fondaparinux are its chemical nature of synthesis, minimal risk of contamination, 100% absolute bioavailability subcutaneously, instant onset of action, a long half-life, direct renal excretion, fewer adverse reactions when compared with direct oral anticoagulants, and being an ideal alternative in conditions where oral anticoagulants are not approved for use or in patients intolerant to low molecular weight heparins (LMWH)."( Fondaparinux Sodium: Recent Advances in the Management of Thrombosis.
Bauersachs, RM,
)
1.87

Dosage Studied

Fondaparinux can be administered safely and efficaciously in a wide variety of patient populations, without the need for dosage modification. We evaluated anti-factor Xa levels in critically ill patients with SRD who were receiving an extended interval dosing regimen of fondaparinUX for VTE prophylaxis.

ExcerptRelevanceReference
" (14 - 20 h) dosing regimens and no metabolism preceding renal excretion."( Fondaparinux: a synthetic heparin pentasaccharide as a new antithrombotic agent.
Bick, RL; Fareed, J; Frapaise, FX; Jeske, WP; Samama, MM; Walenga, JM, 2002
)
1.76
" Thus, with the present dosing regimens, fondaparinux is probably preferable to enoxaparin for the prevention of venous thromboembolism."( Fondaparinux versus enoxaparin for the prevention of venous thromboembolism.
Doggrell, SA, 2002
)
2.02
" In humans, its pharmacokinetic profile is favorable, with a rapid onset of antithrombotic activity and an elimination half-life allowing a convenient once-daily dosing regimen."( The synthetic pentasaccharide fondaparinux: first in the class of antithrombotic agents that selectively inhibit coagulation factor Xa.
Bouthier, J; Branellec, JF; Cariou, R; Donat, F; Duc, G; Duchaussoy, P; El Hajji, M; Garrigou, E; Herbert, JM; Necciari, J; Petitou, M, 2002
)
0.6
" Peak plasma levels are achieved within two hours of dosing and the plasma half-life of fondaparinux is approximately 17 hours."( Fondaparinux (Arixtra): a new anticoagulant.
Giangrande, PL, 2002
)
1.98
" Its favorable pharmacokinetic profile and pharmacodynamics allow for safe and effective once-daily dosing in the majority of populations."( Fondaparinux: basic properties and efficacy and safety in venous thromboembolism prophylaxis.
Bauer, KA, 2002
)
1.76
" One feature of fondaparinux is that it can be administered safely and efficaciously in a wide variety of patient populations, without the need for dosage modification."( Use of selective factor Xa inhibitors in special populations.
Turpie, AG, 2002
)
0.66
" The elimination half-life is about 17 h and it is dose-independent, which allows a convenient once-daily dosing regimen."( Evaluation of the pharmacological properties and clinical results of the synthetic pentasaccharide (fondaparinux).
Gerotziafas, GT; Samama, MM, 2003
)
0.54
" Fondaparinux should further simplify the treatment of this frequent disease since a single once-daily fixed dosage regimen may effectively and safely treat both DVT and PE, an important point especially considering the frequent though clinically silent concomitance of these two thrombotic events."( Current perspectives on the treatment of venous thromboembolism: need for effective, safe and convenient new antithrombotic drugs.
O'Shaughnessy, DF, 2004
)
1.23
" Incremental cost calculations demonstrate that enoxaparin offers advantages over fondaparinux when dosed for 7 days postoperatively in this patient population."( Cost analysis of fondaparinux versus enoxaparin as venous thromboembolism prophylaxis in hip fracture surgery.
Leslie, RB; Spruill, WJ; Wade, WE,
)
0.7
" Both are effective anticoagulants, but their use is associated with a number of impediments, including the need for intensive coagulation monitoring, wide variation in dose-response relationships, multiple drug interactions (in the case of warfarin), and serious immune-mediated thrombocytopenia (in the case of heparin)."( Limitations of traditional anticoagulants.
Hawkins, D, 2004
)
0.32
" The best dosing regimen and optimal timing of first dose for melagatran and ximelagatran remain to be determined, as do the mechanism and impact of drug disturbance of hepatic function."( Advances in anticoagulation therapy: the role of selective inhibitors of factor Xa and thrombin in thromboprophylaxis after major orthopedic surgery.
Andersen, JC, 2004
)
0.32
" The elimination half-life of pentasaccharide is about 17 h, which allows a convenient once-daily dosing regime."( [New anticoagulants in clinical practice].
Boda, Z, 2004
)
0.32
" Otherwise, they have some important limitations (narrow therapeutic window, highly variable dose-response relationship; limitation by the need of parenteral administration for heparins and the risk of heparin-induced thrombocytopenia) which provide opportunities for new antithrombotic drugs."( [Prophylaxis and treatment of venous thromboembolism: the role of new antithrombotic drugs].
Falciani, M; Imberti, D; Prisco, D, 2005
)
0.33
" Both UFH and LMWH undergo pharmacokinetic changes during pregnancy, which sometimes necessitates dosage adjustments."( Minimising the risk of heparin-induced osteoporosis during pregnancy.
Evans, J; Hawkins, D, 2005
)
0.33
" Although both UFH and LMWH have received grade 1A recommendations for the prevention of VTE in at-risk medical patients in the 2004 American College of Chest Physicians consensus conference statements, LMWH has advantages over UFH in its once-daily dosing scheme, reduced incidence of major and minor bleeding events, and reduced incidence of heparin-induced thrombocytopenia."( Emerging strategies in the prevention of venous thromboembolism in hospitalized medical patients.
Spyropoulos, AC, 2005
)
0.33
" Warfarin, on the other hand, can be administered orally but requires the infrastructure for careful patient monitoring and dose adjustments because of its unpredictable dose-response relationship."( Ximelagatran for the prevention of venous thromboembolism following elective hip or knee replacement surgery.
Colwell, C; Mouret, P, 2005
)
0.33
" Warfarin has an unpredictable pharmacokinetic profile and a variable dose-response relationship that requires frequent coagulation monitoring and dose adjustments to maintain a target intensity that is both safe and effective."( Treating patients with venous thromboembolism: initial strategies and long-term secondary prevention.
Bounameaux, H; Huisman, MV, 2005
)
0.33
" Low-molecular-weight heparins, available in the last 20 years, are manufactured from unfractionated heparin and have superior dose-response relationships because of fewer nonspecific reactions with plasma proteins and cells."( Heparin and other rapidly acting anticoagulants.
Hyers, TM, 2005
)
0.33
" Pharmacokinetic studies determined optimal dosing for clinically relevant anticoagulant levels in mice."( Differential metastasis inhibition by clinically relevant levels of heparins--correlation with selectin inhibition, not antithrombotic activity.
Choi, SH; Stevenson, JL; Varki, A, 2005
)
0.33
" Unfractionated heparin can be used in most patients but difficulties with dosing and monitoring often lead to inadequate anticoagulation."( Heparins, low-molecular-weight heparins, and pentasaccharides.
Ansell, JE; Dinwoodey, DL, 2006
)
0.33
" Flexible dosing may reduce bleeding risk and allow easier use by starting the morning after surgery instead of staggered hours on the surgery day."( Flexibility in administration of fondaparinux for prevention of symptomatic venous thromboembolism in orthopaedic surgery.
Colwell, CW; Davidson, BL; Kwong, LM; Turpie, AG, 2006
)
0.62
" Both are effective anticoagulants, but their use is associated with a number of impediments, including the need for intensive coagulation monitoring, wide variation in dose-response relationships, multiple drug interactions (in the case of warfarin), and serious immune-mediated thrombocytopenia (in the case of heparin)."( Role of current and emerging antithrombotics in thrombosis and cancer.
Mousa, SA, 2006
)
0.33
"There remains considerable controversy regarding optimal initial warfarin dosing in patients with acute venous thromboembolism."( Comparison of a single end point to determine optimal initial warfarin dosing (5 mg versus 10 mg) for venous thromboembolism.
DeSantis, SM; Gerhard-Herman, M; Goldhaber, SZ; Kosowsky, JM; Kucher, N; McKean, SC; Quiroz, R, 2006
)
0.33
" We sought to determine if fondaparinux offered financial advantages over low-molecular weight heparin since it is given as a fixed dose over a wide range of patient weights rather then dosed directly on weight and because fondaparinux is not associated with heparin-induced thrombocytopenia (HIT)."( Minimizing costs for treating deep vein thrombosis: the role for fondaparinux.
Jackson, WL; Moores, LK; Shorr, AF; Warkentin, TE, 2007
)
0.87
" Patients at moderate thrombotic risk face a 10 to 20% risk of deep vein thrombosis (DVT) and require prophylaxis with low-dose unfractionated heparin or low molecular weight heparins (LMWHs) at a dosage < 3400 U once daily, or with graduated elastic stockings if their bleeding risk is high."( Prevention of venous thromboembolism.
Pini, M; Spyropoulos, AC, 2006
)
0.33
" Dose-response effects were observed in both studies; however, no statistically significant differences in major bleeding events were found among any groups."( Fondaparinux prevents venous thromboembolism after joint replacement surgery in Japanese patients.
Fuji, T; Fujita, S; Ochi, T, 2008
)
1.79
" Fixed doses of LMWH are customarily used for VTE prophylaxis regardless of body weight or body mass index, but weight-based dosing with larger doses for obese patients may be more effective than fixed doses."( Assessing, preventing, and treating venous thromboembolism: evidence-based approaches.
Nutescu, EA, 2007
)
0.34
" Careful attention to dosing and excellent vascular access site management after cardiac catheterization are required to decrease the risk of bleeding and blood transfusion, which have been associated with increased mortality risk."( New anticoagulant options for ST-elevation myocardial infarction and unstable angina pectoris/non-ST-elevation myocardial infarction.
Bates, ER, 2007
)
0.34
" This reference therapeutic strategy is firstly parenteral and based on low-molecular-weight heparins (LMWH) or fondaparinux, subcutaneously prescribed at fixed dosage based on body weight without any systematic dose adjustment on hemostasis tests."( [Initial treatment of venous thromboembolic events].
Decousus, H; Mismetti, P; Moulin, N, 2007
)
0.55
" Fondaparinux is also characterized by a simple dosing regimen, no need for coagulation monitoring, and potentially a lower risk of HIT compared with LMWH."( The pharmacoeconomics of deep vein thrombosis treatment.
Shorr, AF, 2007
)
1.25
" DTIs have antiplatelet effects, anticoagulant action, and most do not bind to plasma proteins, thereby providing a more consistent dose-response effect than UFH."( Anticoagulation for acute coronary syndromes: from heparin to direct thrombin inhibitors.
Lepor, NE, 2007
)
0.34
"In a retrospective review of 10 patients with known or suspected HIT over a two-year period, medical records were evaluated for baseline laboratory results, treatment selection, initial dosing and monitoring, discontinuation of heparin, and alternative therapies chosen."( Standardizing the management of heparin-induced thrombocytopenia.
Chiappe, J; Fugate, S, 2008
)
0.35
" It is recommended that the clinician carefully evaluate the elderly patient's creatinine clearance and weight before prescribing anticoagulants, particularly when using fixed dosing regimens."( Prevention of venous thromboembolism in the geriatric patient.
Brotman, DJ; Jaffer, AK, 2008
)
0.35
" New anticoagulants have been developed that selectively inhibit thrombin or factor Xa, and have predictable dose-response relationships."( New anticoagulants.
Bauer, KA, 2008
)
0.35
" An almost linear dose-response and high sensitivity of the assay for unfractionated heparin (UFH), low-molecular-weight heparins (LMWHs), r-hirudin, and argatroban was found."( Prothrombinase-induced clotting time assay for determination of the anticoagulant effects of unfractionated and low-molecular-weight heparins, fondaparinux, and thrombin inhibitors.
Calatzis, A; Haas, S; Peetz, D; Rudin, K; Spannagl, M; Wilmer, M, 2008
)
0.55
" Low-molecular-weight heparins (LMWH) are the preferred class of drugs due to multiple advantages, including daily dosing and a decreased risk of heparin-induced thrombocytopenia, to name a few."( Prevention of venous thromboembolism in hospitalized medical patients.
Jaffer, AK; Lenchus, JD, 2008
)
0.35
" This dosage regimen showed a favorable efficacy/safety clinical profile and should be appropriate in preventing venous thromboembolism in patients with moderate renal impairment."( Pharmacokinetic and clinical data supporting the use of fondaparinux 1.5 mg once daily in the prevention of venous thromboembolism in renally impaired patients.
Boyle, DA; Fuji, T; Lensing, AW; Turpie, AG, 2009
)
0.6
" Addition of antithrombin concentrates results in a shift of the dose-response curve."( The reduced anticoagulant effect of fondaparinux at low antithrombin levels.
Ahmad-Nejad, P; Borggrefe, M; Dempfle, CE; Eichner, J; Neumaier, M; Suvajac, N, 2009
)
0.63
" Serum levels indicated adequate absorption of the drug and an effective dosing regimen."( Fondaparinux for prevention of venous thromboembolism in high-risk trauma patients: a pilot study.
Atkinson, K; Bir, N; Kallet, R; Knudson, MM; Lu, JP, 2009
)
1.8
" Its once-daily dosing regimen can improve compliance and reduce cost and eliminate risk of heparin-induced thrombocytopenia."( Fondaparinux for prevention of venous thromboembolism in high-risk trauma patients: a pilot study.
Atkinson, K; Bir, N; Kallet, R; Knudson, MM; Lu, JP, 2009
)
1.8
" All LMWHs tested, as well as fondaparinux, display a similar dose-response in Heptest compared to the chromogenic anti-factor Xa assay."( Heptest-STAT, a new assay for monitoring of low-molecular-weight heparins, is not influenced by pregnancy-related changes of blood plasma.
Ahmad-Nejad, P; Borggrefe, M; Dempfle, CE; Elmas, E; Neumaier, M; Zharkowa, U, 2009
)
0.64
" The optimal drug therapies and dosing strategies for reducing VTE risk are not well defined for many clinical situations, despite the availability of evidence-based guidelines from authoritative sources."( Issues in assessing and reducing the risk for venous thromboembolism.
Dager, WE, 2010
)
0.36
" Dosing strategies for medications used in the ICU are typically developed for use in noncritically ill patients and, therefore, do not account for the altered pharmacokinetic and pharmacodynamic properties encountered in the critically ill as well as the increased potential for drug-drug interactions, given the far greater number of medications ordered."( Adverse drug events associated with disorders of coagulation.
Barletta, JF; Cooper, B; Ohlinger, MJ, 2010
)
0.36
" Additional concerns refer to the dosing-regimens and their practical administration: Fondaparinux, rivaroxaban and dabigatran are dosed to achieve maximum effects very close to their limits of tolerance whereas wide dosing spectra for the low molecular weight herparin (LMWH)'s indicate the potential for dose adaptation and increase."( Prophylaxis of venous thromboembolism: low molecular weight heparin compared to the selective anticoagulants rivaroxaban, dabigatran and fondaparinux.
Fareed, J; Hull, R; Welzel, D, 2011
)
0.8
" Clinicians are increasingly being challenged with making uncertain anticoagulant dosing decisions, as the optimal dosing strategy for most anticoagulants in the obese patient population remains unknown."( Anticoagulating obese patients in the modern era.
Arya, R; Patel, JP; Roberts, LN, 2011
)
0.37
"The administration of low-molecular-weight heparins to obese patients (body mass index [BMI] of ≥30 kg/m(2)) at the dose recommended for VTE prophylaxis has been reported to result in increased thromboembolic events and decreased anti-factor Xa levels, and some evidence indicates that weight-based dosing adjustments may be appropriate."( Effect of fondaparinux prophylaxis on anti-factor Xa concentrations in patients with morbid obesity.
Borrego, M; Burnett, A; Garcia, D; Martinez, L; Streeter, JC; Townsend, K, 2011
)
0.77
" Because dabigatran is cleared principally by the kidneys, dosage adjustments are required in the setting of renal dysfunction."( Advances in anticoagulation: focus on dabigatran, an oral direct thrombin inhibitor.
Augoustides, JG, 2011
)
0.37
" Weak recommendations deal with such issues as loading doses, initiation overlap, monitoring frequency, vitamin K supplementation, patient self-management, weight and renal function adjustment of doses, dosing decision support, drug interactions to avoid, and prevention and management of bleeding complications."( Evidence-based management of anticoagulant therapy: Antithrombotic Therapy and Prevention of Thrombosis, 9th ed: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines.
Crowther, M; Fish, J; Guyatt, GH; Holbrook, A; Kovacs, MJ; Schulman, S; Svensson, PJ; Vandvik, PO; Veenstra, DL; Witt, DM, 2012
)
0.38
" As the drug is mainly eliminated by the kidneys, a reduced dosage (1."( Pharmacokinetics of fondaparinux 1.5 mg once daily in a real-world cohort of patients with renal impairment undergoing major orthopaedic surgery.
Bazzoli, C; Delavenne, X; Laporte, S; Mismetti, P; Nguyen, P; Rosencher, N; Samama, CM; Zufferey, P, 2012
)
0.7
"We studied the pharmacokinetics (PK) of this dosage regimen using data from a real-world cohort of 442 patients with renal impairment (creatinine clearance 20-50 ml/min) undergoing MOS."( Pharmacokinetics of fondaparinux 1.5 mg once daily in a real-world cohort of patients with renal impairment undergoing major orthopaedic surgery.
Bazzoli, C; Delavenne, X; Laporte, S; Mismetti, P; Nguyen, P; Rosencher, N; Samama, CM; Zufferey, P, 2012
)
0.7
"5 mg reduced dosage regimen of fondaparinux available for this context."( Venous thromboembolism prevention with fondaparinux 1.5 mg in renally impaired patients undergoing major orthopaedic surgery. A real-world, prospective, multicentre, cohort study.
Deygas, B; Laporte, S; Mismetti, P; Nguyen, P; Presles, E; Rosencher, N; Samama, CM; Vielpeau, C, 2012
)
0.93
" Thrombotic storm was defined as newly diagnosed multisite venous thromboembolism (VTE) with acute thrombus progression despite conventional or higher than conventional dosing of heparin or low molecular weight heparin."( Treatment, survival, and thromboembolic outcomes of thrombotic storm in children.
Gibson, E; Goldenberg, NA; Knoll, CM; Manco-Johnson, MJ; Mourani, PM; Soep, J; Wang, M, 2012
)
0.38
" This review focuses on pharmacologic information relevant to the dosing of unfractionated heparin, low molecular weight heparin, warfarin, bivalirudin, argatroban and fondaparinux in paediatric patients."( Pharmacokinetics and pharmacodynamics of anticoagulants in paediatric patients.
O'Brien, SH; Yee, DL; Young, G, 2013
)
0.58
" On the basis of dose-response curves, we identified low and moderate doses of EP217609 resulting in similar ex vivo prolongation of the APTT as α-NAPAP analog and comparable ex vivo anti-FXa activity as fondaparinux."( EP217609, a neutralisable dual-action FIIa/FXa anticoagulant, with antithrombotic effects in arterial thrombosis.
Alame, G; Freund, M; Gachet, C; Hechler, B; Magnenat, S; Mangin, PH; Petitou, M; Riehl, N, 2015
)
0.6
" Data regarding dosing and anti-Xa monitoring are lacking in this population."( Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.
An, G; Antigua, A; Bushwitz, J; Cope, J; Patel, A; Zumberg, M, 2015
)
0.69
" Fondaparinux dose, dosing frequency, and anti-Xa level monitoring are described."( Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.
An, G; Antigua, A; Bushwitz, J; Cope, J; Patel, A; Zumberg, M, 2015
)
1.6
"Empirical dose adjustments may be prudent in critically ill patients with renal dysfunction; however, the optimal fondaparinux dosage in this population remains unknown."( Clinical experience with prophylactic fondaparinux in critically ill patients with moderate to severe renal impairment or renal failure requiring renal replacement therapy.
An, G; Antigua, A; Bushwitz, J; Cope, J; Patel, A; Zumberg, M, 2015
)
0.9
" However, there is disagreement regarding the optimal dosing and duration of anticoagulant therapy."( The EFFORT trial: Preoperative enoxaparin versus postoperative fondaparinux for thromboprophylaxis in bariatric surgical patients: a randomized double-blind pilot trial.
Beselman, A; Canner, J; Chen, J; Lidor, A; Magnuson, T; Prokopowicz, G; Schweitzer, M; Steele, KE; Streiff, M; Verde, F; Wyse, R,
)
0.37
"Activated clotting time (ACT) is widely used to guide unfractionated heparin dosing during percutaneous coronary intervention."( Activated clotting time and outcomes during percutaneous coronary intervention for non-ST-segment-elevation myocardial infarction: insights from the FUTURA/OASIS-8 Trial.
Ducrocq, G; Gao, P; Jolly, S; Mehta, SR; Moreno, R; Patel, T; Rao, SV; Steg, PG, 2015
)
0.42
" Low-molecular weight heparins, heparin, and fondaparinux are commonly used agents to prevent VTE, each of which has well established dosing regimens in patients with normal body mass index."( Chemical prophylaxis to prevent venous thromboembolism in morbid obesity: literature review and dosing recommendations.
Lalama, JT; Ritz, LI; Vandiver, JW, 2016
)
0.69
" The increased incidence of major bleeding (excluding fatal) due to fondaparinux could be perhaps lowered by dosage reduction in patients with a mildly decreased creatinine clearance."( [Contribution of novel anticoagulants fondaparinux and dabigatran to venous thromboembolism prevention].
Antonijević, N; Apostolović, M; Jovanović, L; Kanjuh, V; Vukčević, M; Živković, I,
)
0.64
" These NCCN Guidelines Insights summarize the data supporting new dosing recommendations for VTE prophylaxis in obese patients with cancer."( Cancer-Associated Venous Thromboembolic Disease, Version 1.2015.
Ashrani, A; Bockenstedt, PL; Chesney, C; Eby, C; Engh, AM; Fanikos, J; Fenninger, RB; Fogerty, AE; Gao, S; Goldhaber, SZ; Hendrie, P; Holmstrom, B; Kuderer, N; Lee, A; Lee, JT; Lovrincevic, M; McMillian, N; Millenson, MM; Neff, AT; Ortel, TL; Paschal, R; Shattil, S; Siddiqi, T; Smock, KJ; Soff, G; Streiff, MB; Wang, TF; Yee, GC; Zakarija, A, 2015
)
0.42
"A central challenge in designing and administering effective anticoagulants is achieving the proper therapeutic window and dosage for each patient."( A novel, rapid method to compare the therapeutic windows of oral anticoagulants using the Hill coefficient.
Chang, JB; Karan, C; Quinnies, KM; Rand, JH; Realubit, R; Tatonetti, NP, 2016
)
0.43
"Compared to enoxaparin (most commonly dosed 40 mg once daily), the relative risk (RR) of VTE was lowest for edoxaban 30 mg once daily (0."( Safety and Efficacy of New Anticoagulants for the Prevention of Venous Thromboembolism After Hip and Knee Arthroplasty: A Meta-Analysis.
Gage, BF; Ganti, BR; Lee, ED; Lin, H; Nunley, RM; Venker, BT, 2017
)
0.46
" We evaluated anti-factor Xa levels in critically ill patients with SRD who were receiving an extended interval dosing regimen of fondaparinux for VTE prophylaxis."( Assessment of an Extended Interval Fondaparinux Dosing Regimen for Venous Thromboembolism Prophylaxis in Critically Ill Patients with Severe Renal Dysfunction Using Antifactor Xa Levels.
Riley, LK; Tennenberg, SD; Wahby, KA, 2017
)
0.94
" As an alternative to inconvenient and expensive injections of fondaparinux, personalized dosing of a direct oral anticoagulant was sought using clinical pharmacology techniques."( Personalized Anticoagulation: Guided Apixaban Dose Adjustment to Compensate for Pharmacokinetic Abnormalities Related to Short-Bowel Syndrome.
Kim, RB; Pollak, PT; Sun, GR, 2018
)
0.72
" We performed daily assessment of antithrombin- and fondaparinux-specific anti-Xa levels in a 50-year-old female of unknown ethnicity to ensure that fondaparinux dosing was maintained within an acceptable range."( Monitoring Fondaparinux in the Setting of Antithrombin Deficiency.
Feldman, AZ; Pham, HP; Simmons, SC; Staley, EM; Williams, LA, 2019
)
1.15
" We describe a patient diagnosed with anti-phospholipase A2 receptor antibody positive membranous nephropathy and recurrent VTE while on therapeutic dosing of apixaban."( Recurrent venous thromboembolism in primary membranous nephropathy despite direct Xa inhibitor therapy.
Crona, DJ; Derebail, VK; Mooberry, MJ; Nachman, PH; Reynolds, ML, 2019
)
0.51
"This study demonstrates the stable long-term pediatric dosing of fondaparinux with similar efficacy and safety when compared to other anticoagulants."( FondaKIDS III: A long-term retrospective cohort study of fondaparinux for treatment of venous thromboembolism in children.
Shen, X; Wile, R; Young, G, 2020
)
1.04
" Given the favourable safety profile of NOACs (especially if a reduced dosage of Apixaban or Rivaroxaban is initiated after at least six months of therapeutic anticoagulation), extended oral anticoagulation of indefinite duration should be considered for all patients with intermediate risk of recurrence."( [Antithrombotic Treatment of Pulmonary Embolism].
Ebner, M; Lankeit, M, 2020
)
0.56
"Pediatric patients with obesity may benefit from proactively adjusting enoxaparin dosing on initiation of therapy."( Low-Molecular-Weight Heparin and Fondaparinux Use in Pediatric Patients With Obesity.
Fenn, NE; Garner, MP; Onuoha, CP, 2021
)
0.9
" Patients were treated with LMWH or FPX at therapeutic dosage and reduction was considered in selected cases."( Comparison of Fondaparinux and Low-Molecular-Weight Heparin in the Treatment of Portal Vein Thrombosis in Cirrhosis.
Angeli, P; Bombonato, G; Burra, P; Piano, S; Sacerdoti, D; Senzolo, M; Shalaby, S; Simioni, P; Tonello, S; Tonon, M; Zanetto, A, 2021
)
0.98
" This study characterizes the pharmacokinetics (PK) and pharmacodynamics (PD) of fondaparinux in DD-CKD patients undergoing renal replacement therapy (RRT), to assess dosing strategies."( Population pharmacokinetics-pharmacodynamics of fondaparinux in dialysis-dependent chronic kidney disease patients undergoing chronic renal replacement therapy.
Bednářová, V; Hartinger, JM; Hladinová, Z; Krekels, EHJ; Matthios, A; Michaličková, D; Polakovič, V; Slanař, O; Szonowská, B; Tesař, V, 2022
)
1.2
"Model-based simulations showed that standard dosing (2."( Population pharmacokinetics-pharmacodynamics of fondaparinux in dialysis-dependent chronic kidney disease patients undergoing chronic renal replacement therapy.
Bednářová, V; Hartinger, JM; Hladinová, Z; Krekels, EHJ; Matthios, A; Michaličková, D; Polakovič, V; Slanař, O; Szonowská, B; Tesař, V, 2022
)
0.98
" He was treated with azithromycin, isoprinosine, lopinavir, and fondaparinux with thromboprophylaxis dosage since admission."( The Challenging Anticoagulant Therapy in COVID19 Patient with Associated Coagulopathy.
Airlangga, MP; Fatimah, FN; Miftahussurur, M; Pradana, AD; Rianda, RA; Rianda, RV; Subkhan, M, 2021
)
0.86
" We recommend research to refine VTE risk stratification, and to establish the optimal dosing and duration of thromboprophylaxis."( Thromboprophylaxis for venous thromboembolism prevention in hospitalized patients with cirrhosis: Guidance from the SSC of the ISTH.
Hernandez-Gea, V; Lisman, T; Magnusson, M; Roberts, LN; Stanworth, S; Thachil, J; Tripodi, A, 2022
)
0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (1)

RoleDescription
anticoagulantAn agent that prevents blood clotting.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (3)

ClassDescription
amino sugarAny sugar having one or more alcoholic hydroxy groups replaced by substituted or unsubstituted amino groups.
oligosaccharide sulfateAny carbohydrate sulfate that is an oligosaccharide carrying at least one O-sulfo substituent.
pentasaccharide derivativeAn oligosaccharide derivative that is formally obtained from a pentasaccharide.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (1)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Coagulation factor XHomo sapiens (human)IC50 (µMol)0.01100.00030.593710.0000AID1548117
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (4)

Processvia Protein(s)Taxonomy
proteolysisCoagulation factor XHomo sapiens (human)
blood coagulationCoagulation factor XHomo sapiens (human)
positive regulation of cell migrationCoagulation factor XHomo sapiens (human)
positive regulation of TOR signalingCoagulation factor XHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (4)

Processvia Protein(s)Taxonomy
serine-type endopeptidase activityCoagulation factor XHomo sapiens (human)
calcium ion bindingCoagulation factor XHomo sapiens (human)
protein bindingCoagulation factor XHomo sapiens (human)
phospholipid bindingCoagulation factor XHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (6)

Processvia Protein(s)Taxonomy
extracellular regionCoagulation factor XHomo sapiens (human)
endoplasmic reticulum lumenCoagulation factor XHomo sapiens (human)
Golgi lumenCoagulation factor XHomo sapiens (human)
plasma membraneCoagulation factor XHomo sapiens (human)
external side of plasma membraneCoagulation factor XHomo sapiens (human)
extracellular spaceCoagulation factor XHomo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (2)

Assay IDTitleYearJournalArticle
AID1346098Human serpin family C member 1 (Blood coagulation components)2002Clinical pharmacokinetics, , Volume: 41 Suppl 2Fondaparinux sodium mechanism of action: identification of specific binding to purified and human plasma-derived proteins.
AID1548117Inhibition of coagulation factor 10a (unknown origin) incubated for 2 mins in presence of AT3 by chromogenic substrate based fluorescence assay2020Journal of medicinal chemistry, 04-23, Volume: 63, Issue:8
Modulating Heparanase Activity: Tuning Sulfation Pattern and Glycosidic Linkage of Oligosaccharides.
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,144)

TimeframeStudies, This Drug (%)All Drugs %
pre-19900 (0.00)18.7374
1990's0 (0.00)18.2507
2000's500 (43.71)29.6817
2010's545 (47.64)24.3611
2020's99 (8.65)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 82.97

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be very strong demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index82.97 (24.57)
Research Supply Index7.17 (2.92)
Research Growth Index4.51 (4.65)
Search Engine Demand Index149.95 (26.88)
Search Engine Supply Index2.00 (0.95)

This Compound (82.97)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials112 (9.41%)5.53%
Reviews355 (29.83%)6.00%
Case Studies146 (12.27%)4.05%
Observational24 (2.02%)0.25%
Other553 (46.47%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (67)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery [NCT01267305]362 participants (Actual)Interventional2011-01-31Completed
Women's Cancer Center Protocol #45: Prolonged Venous Thromboembolism Prophylaxis With Fondaparinux in Gynecologic Oncology Patients: An Open Label Phase II Trial [NCT00381888]Phase 244 participants (Actual)Interventional2007-01-31Completed
Pharmacokinetic Study of Fondaparinux in Inpatients With Renal Dysfunction [NCT01121770]Phase 19 participants (Actual)Interventional2010-05-31Completed
Safety of Fondaparinux as Postpartum Venous Thromboembolism Prophylaxis [NCT04447378]Phase 460 participants (Actual)Interventional2017-09-01Completed
Direct Oral Anticoagulants (DOACs) Versus LMWH +/- Warfarin for VTE in Cancer: A Randomized Effectiveness Trial (CANVAS Trial) [NCT02744092]811 participants (Actual)Interventional2016-12-13Completed
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Pulmonary Thromboembolism (PE) [NCT00981409]Phase 341 participants (Actual)Interventional2007-07-31Completed
Fondaparinux in Patients With Acute Heparin-Induced Thrombocytopenia [NCT00603824]Phase 40 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to PI relocated)
An International, Multicentre, Randomised, Open, Controlled, Two-parallel Group, Phase II Pilot Study to Evaluate the Efficacy and Safety of ARIXTRA™ for Anticoagulation of Patients With Atrial Fibrillation Undergoing Electric Cardioversion Following Tran [NCT00911300]Phase 2349 participants (Actual)Interventional2009-08-31Completed
The Safety and Efficacy of Fondaparinux 1,5 mg for the Prevention of Venous Thromboembolism in Medical Patients With Renal Insufficiency [NCT00927602]Phase 4206 participants (Actual)Interventional2009-04-30Terminated(stopped due to study was stopped after enrolment of about 200 patients for slow recruitment)
Xarelto® Regulatory Post-Marketing Surveillance [NCT01029743]3,388 participants (Actual)Observational2009-12-31Completed
A Pilot Study to Determine the Feasibility of Conducting a Randomized Clinical Trial Comparing Fondaparinux Sodium (Arixtra) Once Daily With Enoxaparin (Lovenox®) Twice Daily With Respect to Preventing VTE After Bariatric Surgery in Obese Patients [NCT00894283]Early Phase 1198 participants (Actual)Interventional2009-06-30Completed
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Elective Total Hip Replacement Surgery [NCT00320398]Phase 3114 participants (Actual)Interventional2006-01-30Completed
07-742 Phase I/ Feasibility Study of Short Term Fondaparinux (Arixtra) in Chemotherapy-Pretreated Ovarian Carcinoma Patients at High Risk of Progression [NCT00659399]Phase 10 participants (Actual)Interventional2008-01-31Withdrawn(stopped due to Low accrual)
A Multicentre, Randomized, Open-label Study to Evaluate the Efficacy andSafety of Fondaparinux Versus Low Molecular Weight Heparin(Nadroparin) in Patients Requiring Rigid or Semi-rigid Immobilization for at Least 21 Days and up to 45 Days Because of Isola [NCT00843492]Phase 31,351 participants (Actual)Interventional2008-12-31Completed
An International, Multicentre, Randomised, Double-blind, Placebo-controlled, Two-parallel Group, Phase III Study to Evaluate the Efficacy and Safety of ARIXTRA (2.5mg Subcutaneously) for the Treatment of Patients With Acute Symptomatic Isolated Superficia [NCT00443053]Phase 33,002 participants (Actual)Interventional2007-03-31Completed
FondaparinUx Trial With Unfractionated Heparin (UFH) During Revascularization in Acute Coronary Syndromes (ACS) (FUTURA). A Prospective Study Evaluating the Safety of Two Regimens of Adjunctive Intravenous UFH During PCI in High Risk Patients With Unstabl [NCT00790907]Phase 43,235 participants (Actual)Interventional2009-02-28Completed
Prophylaxis Against Thromboembolic Disease Following Orthopaedic Surgeries on Extremities [NCT00767559]330 participants (Anticipated)Interventional2008-11-30Active, not recruiting
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal (Urology,Obstetrics,Gynecology) [NCT01390883]475 participants (Actual)Observational2008-12-31Completed
Special Drug Use Investigation for ARIXTRA (Fondaparinux) Abdominal General Surgery [NCT01390896]329 participants (Actual)Observational2009-09-30Completed
Evaluate (Post Approval) the Adherence to the Prescribing Information for ARIXTRA® (Fondaparinux) in ACS Patients- Commitment of the Fondaparinux EU-RMP [NCT01406301]1 participants (Actual)Observational2008-03-31Completed
A Phase 3, Open-label, Randomized, Multi-center, Controlled Trial to Evaluate the Pharmacokinetics and Pharmacodynamics of Edoxaban and to Compare the Efficacy and Safety of Edoxaban With Standard of Care Anticoagulant Therapy in Pediatric Subjects From B [NCT02798471]Phase 3290 participants (Actual)Interventional2017-03-27Completed
Prophylaxis of Venous Thromboembolism in Patients With a Nonsurgical Fracture of the Lower Extremity Immobilised in a Below-Knee Plaster Cast [NCT00881088]Phase 2/Phase 3669 participants (Anticipated)Interventional2009-04-30Recruiting
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism After Hip Fracture Surgery [NCT00320424]Phase 348 participants (Actual)Interventional2006-02-16Completed
Switching From Arixtra (Fondaparinux) to Angiomax (Bivalirudin) or Unfractionated Heparin in Patients With Acute Coronary Syndromes (ACS) Without ST-segment Elevation Undergoing Percutaneous Coronary Intervention (PCI): SWITCH III [NCT00464087]Phase 3100 participants (Actual)Interventional2007-06-30Completed
Choice of the Optimal Method for Treatment of Acute Thrombophlebitis of the Varicose Great Saphenous Vein: Comparison of Endovenous Laser Ablation and Conservative Approach [NCT05001776]Phase 4105 participants (Actual)Interventional2021-08-16Completed
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in the Treatment of Acute Deep Vein Thrombosis (DVT) [NCT00911157]Phase 339 participants (Actual)Interventional2008-06-30Completed
Special Drug Use Investigation for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment [NCT01428531]200 participants (Actual)Observational2012-01-31Completed
Special Drug Use Investigation (Retrospective) for Arixtra® (Fondaparinux) Venous Thromboembolism Treatment (Over 100kg) [NCT01428544]5 participants (Actual)Observational2012-03-31Completed
Prospective, Multicentre, Open-label Study Evaluating 1.5 mg/Day of Fondaparinux,in Venous Thromboembolic Events Prevention in Patients With Renal Impairment and Undergoing a Major Orthopaedic Surgery. PROPICE Study [NCT00555438]Phase 4451 participants (Actual)Interventional2007-06-30Completed
Randomized, Single Blind, Parallel Study to Compare the Safety and Efficacy of ARIXTRA to Enoxaparine in Patients Undergoing Elective Major Hip or Knee Replacement or a Revision of Components. [NCT00328939]Phase 3240 participants Interventional2004-05-31Completed
Thromboprophylaxis in the Morbidly Obese With Weight Based Dosing of Fondaparinux: A Pharmacodynamic Study [NCT00346879]Phase 10 participants (Actual)Interventional2006-08-31Withdrawn(stopped due to Funding withdrawn; study closed due to lack of accrual.)
An International, Randomized, Double-blind Study Evaluating the Efficacy and Safety of Fondaparinux Versus Enoxaparin in the Acute Treatment of Unstable Angina/Non ST-segment Elevation MI Acute Coronary Syndromes [NCT00139815]Phase 320,078 participants (Actual)Interventional2003-04-30Completed
Pharmacokinetics of Fondaparinux (Arixtra) to Critically Ill Patients on Vasopressor Therapy [NCT00424281]40 participants Observational2007-02-28Not yet recruiting
A Pilot Dose-finding and Pharmacokinetic Study of Fondaparinux in Children With Deep Vein Thrombosis or Heparin-induced Thrombocytopenia [NCT00412464]Phase 124 participants (Actual)Interventional2006-09-30Completed
Systematische Dokumentation Von Patienten Mit Akutem HIT-Verdacht [NCT01304238]195 participants (Actual)Observational2009-02-28Completed
Pharmacokinetic Properties of Fondaparinux Sodium in Morbidly Obese Volunteers [NCT00436787]Phase 221 participants (Anticipated)Interventional2007-02-28Completed
Fondaparinux Compared With Heparin to Prevent Thrombotic Complications and Graft Failure in Patients Undergoing Coronary Artery Bypass Graft Surgery [NCT00474591]Phase 3100 participants (Anticipated)InterventionalNot yet recruiting
Phase I Feasibility Study of the Combination of Fondaparinux (Arixtra) With Chemotherapy in Patients With Advanced Non-Small Cell Lung Cancer [NCT00476216]Phase 123 participants (Actual)Interventional2007-09-30Completed
Studies of Fondaparinux in Patients With Renal Dysfunction: PK Study of Fondaparinux in Outpatients With Renal Dysfunction [NCT00483600]0 participants (Actual)Interventional2007-08-31Withdrawn(stopped due to unable to enroll)
Arixtra(Fondaparinux) vs. Lovenox (Enoxaparin) in Prevention of DVT in Acute Medically Ill, Non-surgical Patients [NCT00521885]1 participants (Actual)Interventional2007-09-30Terminated(stopped due to Study stopped due to lack of accrual)
A Multicenter, Randomized, Double-blind, Parallel Group Trial to Demonstrate the Efficacy of Fondaparinux Sodium in Association With Intermittent Pneumatic Compression (IPC) Versus IPC Used Alone for the Prevention of Venous Thromboembolic Events in Subje [NCT00038961]Phase 31,309 participants (Actual)Interventional2001-11-30Completed
Phase IV, Single Arm Study to Obtain Information Regarding the Safety and Efficacy of Fondaparinux Given Outpatient for Treatment of Acute Pulmonary Embolism [NCT00378027]0 participants (Actual)Observational2006-08-31Withdrawn(stopped due to enrollment criteria not met by PI patient population)
An International Randomized Study Evaluating the Efficacy and Safety of Fondaparinux Versus Control Therapy in a Broad Range of Patients With ST Segment Elevation Acute Myocardial Infarction. [NCT00064428]Phase 312,092 participants (Actual)Interventional2003-08-31Completed
[NCT00060554]Phase 2300 participants Interventional2003-04-30Withdrawn(stopped due to Drug sold to Sanofi-Aventis who sold it to GSK; OBS no longer owns study and does not have data.)
A Randomized Control Trial of Anticoagulation and Inferior Vena Cava Filters in Cancer Patients With A Venous Thromboembolism [NCT00423683]Phase 364 participants (Actual)Interventional2007-01-31Terminated(stopped due to Study accrual stopped due to poor accrual.)
A Phase II Trial Using Fondaparinux in Patients With Confirmed or Suspected Heparin-Induced Thrombocytopenia (HIT) [NCT00673439]Phase 23 participants (Actual)Interventional2007-11-30Terminated(stopped due to study terminated due to low accrual)
Extended Deep Venous Thrombosis Prophylaxis in Gynecologic Oncology Surgery With Intermittent Compression Devices (ICD) With or Without Postoperative Arixtra (Fondaparinux Sodium): A Randomized Controlled Trial [NCT00539942]Phase 37 participants (Actual)Interventional2007-04-30Terminated(stopped due to Problems with accrual)
Thromboprophylaxis With Fondaparinux of Deep Vein Thrombosis and Pulmonary Embolism in the Acutely-ill Medical Inpatients With Thrombocytopenia [NCT01727401]Phase 47 participants (Actual)Interventional2012-11-30Terminated(stopped due to Slow recruitment rate)
Pilot Study Evaluating Alterations in Thrombogenicity and Platelet Reactivity Following Lower Extremity Arthroplasty [NCT01809054]Phase 454 participants (Actual)Interventional2012-04-30Completed
Fondaparinux as Monotherapy for Deep Vein Thrombosis and/or Pulmonary Embolism (Pilot Study) [NCT00413504]30 participants (Actual)Interventional2006-04-30Completed
Assessment of the Safety and Efficacy of Fondaparinux as an Anticoagulant in Haemofiltration in Patients With Acute Renal Failure. [NCT00256100]20 participants (Actual)Interventional2004-06-30Terminated(stopped due to Teh Priincipal investigator responsible for the trial no longer employed at the study site.)
Clinical Evaluation of GSK576428 (Fondaparinux Sodium) in Prevention of Venous Thromboembolism (VTE) After Abdominal Surgery [NCT00333021]Phase 3127 participants (Actual)Interventional2006-05-31Completed
ARIXTRA® Physician Adherence to the Prescribing Information in Isolated Superficial Vein Thrombosis (SVT) Patients. [NCT01691495]1 participants (Actual)Observational2012-10-31Completed
Prospective Study on the Treatment of Unsuspected Pulmonary Embolism in Cancer Patients [NCT01727427]695 participants (Actual)Observational2012-11-30Completed
Superficial Vein Thrombosis (SVT) Treated for Forty-five Days With Rivaroxaban Versus Fondaparinux [NCT01499953]Phase 3472 participants (Actual)Interventional2012-04-30Completed
Pilot Pharmacoeconomic Evaluation of Fondaparinux Treatment of Pulmonary Embolism (PE) Compared to Treatment With Unfractionated Heparin [NCT00377091]Phase 40 participants (Actual)Interventional2007-06-30Withdrawn(stopped due to Study pulled due to a grant disagreement between the U of M and SMDC)
Comparative Analysis of Injectable Anticoagulants for Thromboprophylaxis Post Cancer-related Surgery [NCT01444612]4,068 participants (Actual)Observational2010-02-28Completed
Platelet Inhibition With GP IIb/IIIa Inhibitor in Critically Ill Patients With Coronavirus Disease 2019 (COVID-19). A Compassionate Use Protocol [NCT04368377]Phase 25 participants (Actual)Interventional2020-04-06Completed
Retrospektive Studie zu Patientinnen, Die pränatal, Perinatal Oder Postnatal Prophylaktisch Oder Therapeutisch Mit Fondaparinux Behandelt Wurden [NCT01004939]120 participants (Actual)Observational2010-03-31Completed
A Study of the Efficacy of Preventive Dosing of Fondaparinux Sodium Versus Placebo for the Prevention of Venous Thromboembolism (VTE) in Patients Undergoing Coronary Bypass Surgery Receiving Routine Mechanical Prophylaxis [NCT00789399]78 participants (Actual)Interventional2009-11-19Terminated(stopped due to Principal Investigator moved to another region of the country)
Safety of Fondaparinux as Routine VTE Prophylaxis in Medical ICU Patients: An Investigator Initiated Protocol [NCT00493896]Phase 327 participants (Actual)Interventional2007-07-31Terminated(stopped due to low enrollment)
The Use of Fondaparinux in Preventing Thromboembolism in High Risk Trauma Patients [NCT00531843]Phase 2/Phase 3105 participants (Actual)Interventional2007-12-31Completed
Use of Fondaparinux in Critically Ill Patients With Renal Failure [NCT01467583]Phase 432 participants (Actual)Interventional2011-11-30Completed
Increased Risk of Venous Thromboembolism and Higher Hypercoagulable State in Patients Recovered in Intensive Care Unit and in Medical Ward for Coronavirus Disease 2019 (COVID-19) [NCT04359212]90 participants (Actual)Observational2020-05-01Completed
Phase III Clinical Study of DU-176b (Venous Thromboembolism): Japanese, Multicenter, Open-label Study of DU-176b in Patients With Severe Renal Impairment (SRI) Undergoing Orthopedic Surgery of the Lower Limbs [NCT01857583]Phase 380 participants (Actual)Interventional2012-03-31Completed
The Effects of Arixtra on Wound Drainage Following Total Joint Arthroplasty [NCT00909064]Phase 4114 participants (Actual)Interventional2009-06-30Completed
Risk of Hemorrhage in Patients Prescribed Arixtra Compared to LMWH [NCT01064362]13,442 participants (Actual)Observational2010-01-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00320398 (11) [back to overview]Percentage of Participants With Minor Bleeding
NCT00320398 (11) [back to overview]Percentage of Participants With All Deep Vein Thrombosis (DVT)
NCT00320398 (11) [back to overview]Percentage of Participants With Proximal DVT
NCT00320398 (11) [back to overview]Percentage of Participants With Pulmonary Embolism During Efficacy Period
NCT00320398 (11) [back to overview]Percentage of Participants With Symptomatic DVT During Main Efficacy Period
NCT00320398 (11) [back to overview]Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period
NCT00320398 (11) [back to overview]Number of Transfused Participants
NCT00320398 (11) [back to overview]Volume of Transfusion
NCT00320398 (11) [back to overview]Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths
NCT00320398 (11) [back to overview]Percentage of Participants With Major Bleeding
NCT00320398 (11) [back to overview]Percentage of Participants With Distal Only DVT
NCT00320424 (11) [back to overview]Rate of Symptomatic DVT
NCT00320424 (11) [back to overview]Rate of Proximal DVT During Treatment Period
NCT00320424 (11) [back to overview]Rate of PE During Treatment Period
NCT00320424 (11) [back to overview]Rate of Major Bleeding During Treatment Period
NCT00320424 (11) [back to overview]Rate of DVT During Treatment Period
NCT00320424 (11) [back to overview]Rate of Distal Only DVT During Treatment Period
NCT00320424 (11) [back to overview]Number of Transfused Participants
NCT00320424 (11) [back to overview]Number of Participants With Major Bleeding During Treatment Period
NCT00320424 (11) [back to overview]Summary of Units Transfused
NCT00320424 (11) [back to overview]Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)
NCT00320424 (11) [back to overview]Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death
NCT00381888 (2) [back to overview]Number of Patients With Venous Thromboembolism at Week 4
NCT00381888 (2) [back to overview]Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.
NCT00412464 (5) [back to overview]Adverse Events
NCT00412464 (5) [back to overview]Bleeding Events
NCT00412464 (5) [back to overview]Number of Abnormal Lab Results Resulting in Adverse Events.
NCT00412464 (5) [back to overview]Therapeutic Plasma Concentration of Fondaparinux at 21 Days
NCT00412464 (5) [back to overview]Thrombocytopenic Events
NCT00423683 (4) [back to overview]Resolution of PE
NCT00423683 (4) [back to overview]Resolution of DVT
NCT00423683 (4) [back to overview]Overall Survival
NCT00423683 (4) [back to overview]Adverse Outcomes
NCT00443053 (7) [back to overview]Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77
NCT00443053 (7) [back to overview]Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77
NCT00443053 (7) [back to overview]Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77
NCT00443053 (7) [back to overview]Number of Any Adjudicated Bleeding Events at Days 47 and 77
NCT00443053 (7) [back to overview]Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77
NCT00443053 (7) [back to overview]Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77
NCT00443053 (7) [back to overview]Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT00464087 (4) [back to overview]Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis
NCT00464087 (4) [back to overview]The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge
NCT00531843 (3) [back to overview]Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)
NCT00531843 (3) [back to overview]Normal Trough and Peak Fondaparinux Concentration
NCT00531843 (3) [back to overview]Increased Bleeding Attributed to Fondaparinux
NCT00539942 (2) [back to overview]Incidence of Untoward Effects With Arixtra
NCT00539942 (2) [back to overview]Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra
NCT00555438 (5) [back to overview]Number of Patients With Major Bleedings at 1 Month ± 5 Days.
NCT00555438 (5) [back to overview]Death at 1 Month ± 5 Days
NCT00555438 (5) [back to overview]Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10
NCT00555438 (5) [back to overview]Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days
NCT00555438 (5) [back to overview]Number of Patients With Major Bleedings Between Day 1 and Day 10.
NCT00673439 (2) [back to overview]the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux
NCT00673439 (2) [back to overview]Number of Participants Showing Clinically Significant Bleeding
NCT00789399 (2) [back to overview]Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11
NCT00789399 (2) [back to overview]Number of Participants With a Venous Thromboembolisms to 35 Days
NCT00790907 (8) [back to overview]Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period
NCT00790907 (8) [back to overview]Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30
NCT00790907 (8) [back to overview]Number of Participants With Major Bleeding During the Peri-PCI Period
NCT00790907 (8) [back to overview]Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period
NCT00790907 (8) [back to overview]Number of Participants With Minor Bleeding During the Peri-PCI Period
NCT00790907 (8) [back to overview]Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30
NCT00790907 (8) [back to overview]Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30
NCT00790907 (8) [back to overview]Number of Participants With Major PCI-related Procedural Complications
NCT00843492 (7) [back to overview]Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact
NCT00843492 (7) [back to overview]Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact
NCT00843492 (7) [back to overview]Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact
NCT00843492 (7) [back to overview]Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact
NCT00843492 (7) [back to overview]Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact
NCT00843492 (7) [back to overview]Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death
NCT00843492 (7) [back to overview]Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization
NCT00909064 (3) [back to overview]Number of Days Until a Dry Wound
NCT00909064 (3) [back to overview]Incidence of Wound Infection
NCT00909064 (3) [back to overview]Number of Days in Hospital.
NCT00911157 (5) [back to overview]Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)
NCT00911157 (5) [back to overview]Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10
NCT00911157 (5) [back to overview]Percentage of Participants With a Bleeding Event
NCT00911157 (5) [back to overview]Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
NCT00911157 (5) [back to overview]Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event
NCT00911300 (10) [back to overview]Number of Participants Who Were Re-hospitalized
NCT00911300 (10) [back to overview]Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm
NCT00911300 (10) [back to overview]Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days
NCT00911300 (10) [back to overview]Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE
NCT00911300 (10) [back to overview]Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event
NCT00981409 (5) [back to overview]The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)
NCT00981409 (5) [back to overview]The Percentage of Participants With a Bleeding Event
NCT00981409 (5) [back to overview]The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)
NCT00981409 (5) [back to overview]Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10
NCT00981409 (5) [back to overview]The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse
NCT01004939 (37) [back to overview]Mean Head Circumference of Newborn
NCT01004939 (37) [back to overview]Mean Height of Newborn
NCT01004939 (37) [back to overview]Mean Weight of Newborn
NCT01004939 (37) [back to overview]Number of Hours After Birth at Which Fondaparinux Administration Was Restarted
NCT01004939 (37) [back to overview]Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered
NCT01004939 (37) [back to overview]"Number of Newborns Who Had a Healthy Postnatal Classification"
NCT01004939 (37) [back to overview]Duration of Hospitalizations Before, During, and After Fondaparinux Administration
NCT01004939 (37) [back to overview]Mean APGAR Score at 1, 5, and 10 Minutes After Birth
NCT01004939 (37) [back to overview]Number of Newborns With Abnormalities
NCT01004939 (37) [back to overview]Number of Participants Administered the Indicated Dose of Fondaparinux Per Day
NCT01004939 (37) [back to overview]Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth
NCT01004939 (37) [back to overview]Number of Participants Hospitalized Because of Thromboembolic Treatment
NCT01004939 (37) [back to overview]Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals
NCT01004939 (37) [back to overview]Number of Participants Who Delivered a Single Child Versus Twins
NCT01004939 (37) [back to overview]Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With and Without Complications Under Fondaparinux Therapy
NCT01004939 (37) [back to overview]Number of Participants With Bleedings Under Fondaparinux Therapy
NCT01004939 (37) [back to overview]Number of Participants With Bleedings Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With Complications Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With Skin Changes Under Fondaparinux Therapy
NCT01004939 (37) [back to overview]Number of Participants With Skin Changes Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth
NCT01004939 (37) [back to overview]Number of Participants With the Indicated Reason for Change to Fondaparinux
NCT01004939 (37) [back to overview]Number of Participants With the Indicated Reason for the End of Fondaparinux Administration
NCT01004939 (37) [back to overview]Number of Participants With the Indicated Type of Conception/Fertilization
NCT01004939 (37) [back to overview]Number of Participants With Thromboembolisms Under Fondaparinux Therapy
NCT01004939 (37) [back to overview]Number of Participants With Thromboembolisms Under UFH/LMWH Therapy
NCT01004939 (37) [back to overview]Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy
NCT01004939 (37) [back to overview]Duration From Start of Fondaparinux Therapy to HIT
NCT01004939 (37) [back to overview]Duration From Start of UFH/LMWH Therapy to HIT
NCT01004939 (37) [back to overview]Duration From Start of UFH/LMWH Therapy to Skin Change
NCT01004939 (37) [back to overview]Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration
NCT01004939 (37) [back to overview]Duration of Fondaparinux Administration
NCT01004939 (37) [back to overview]Duration of Postnatal Fondaparinux Administration
NCT01004939 (37) [back to overview]Duration of Prenatal Fondaparinux Administration
NCT01064362 (2) [back to overview]Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
NCT01064362 (2) [back to overview]Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)
NCT01304238 (6) [back to overview]Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II
NCT01304238 (6) [back to overview]Number of Participants With Fatal Complications After the Occurrence of HIT II
NCT01304238 (6) [back to overview]Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II
NCT01304238 (6) [back to overview]Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II
NCT01304238 (6) [back to overview]Number of Participants Who Underwent Amputation After the Occurrence of HIT II
NCT01304238 (6) [back to overview]Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II
NCT01467583 (2) [back to overview]To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period
NCT01467583 (2) [back to overview]To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.
NCT01499953 (6) [back to overview]Rate of Major VTE
NCT01499953 (6) [back to overview]Clinically Relevant Non-major, Minor and Total (Any) Bleeding
NCT01499953 (6) [back to overview]Rates of Surgery for SVT
NCT01499953 (6) [back to overview]Rate of Objectively Confirmed VTE Complications
NCT01499953 (6) [back to overview]Major Bleeding (Main Safety Outcome)
NCT01499953 (6) [back to overview]Composite Primary Efficacy Outcome
NCT01809054 (2) [back to overview]Blood Loss
NCT01809054 (2) [back to overview]Deep Vein Thrombosis
NCT01857583 (1) [back to overview]Incidence of Any Adjudicated Bleeding Events
NCT02744092 (11) [back to overview]Cumulative Rates of Major Bleeding
NCT02744092 (11) [back to overview]Cumulative Non-Fatal VTE Recurrence at 6 Months (%)
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 3-months
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire
NCT02744092 (11) [back to overview]Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire
NCT02744092 (11) [back to overview]Health Related Quality of Life (Mental Health) Reported by Participants Via the Optum SF-12v2 Health Survey Questionnaire at 6-months
NCT02798471 (14) [back to overview]Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With Deep Vein Thrombosis, Catheter-related Thrombosis, Sino-venous Thrombosis, and Pulmonary Embolism During the Main, Extension, and Overall Treatment Periods Following Edoxaban or Standard of Care Treatment
NCT02798471 (14) [back to overview]Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment
NCT02798471 (14) [back to overview]Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)
NCT02798471 (14) [back to overview]Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)
NCT02798471 (14) [back to overview]Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)
NCT02798471 (14) [back to overview]Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)

Percentage of Participants With Minor Bleeding

Minor bleeding was defined as the clinically overt bleeding not meeting the criteria for major bleeding like: (Fatal bleed; Including retroperitoneal and intracranial bleeding, or bleed in critical organ [eye, adrenal gland, pericardium, spine]; c) Reoperation due to bleeding or hematoma at operative site; d) Bleeding leading to hemoglobin (Hb) fall > = 2 g/dL(1.6 mmol/L) within 48 hour of the bleed; e)Bleeding that required transfusion of RBCs or WB derived from >= 900 mL of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2), and which were considered more than expected in the clinical context. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg1.7
Fondaparinux 2.5 mg3.6

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Percentage of Participants With All Deep Vein Thrombosis (DVT)

The percentage of participants with All DVT were reported, where the analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg8.3
Fondaparinux 2.5 mg2.2

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Percentage of Participants With Proximal DVT

The percentage of participants with DVT (proximal) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg0
Fondaparinux 2.5 mg0

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Percentage of Participants With Pulmonary Embolism During Efficacy Period

The percentage of participants with pulmonary embolism (pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia ) were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg0
Fondaparinux 2.5 mg0

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Percentage of Participants With Symptomatic DVT During Main Efficacy Period

The percentage of participants with different symptoms of DVT (proximal) like pain or tenderness, swelling, warmth, redness or discoloration, and distention of surface veins, post the total hip replacement surgery were reported, where analysis was done using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg0
Fondaparinux 2.5 mg0

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Percentage of Participants With Venous Thromboembolism (VTE) During Efficacy Period

The percentage of participants with VTE, who underwent elective total hip replacement surgery, detected by routine venography, during the treatment period were reported. The percentage VTE was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg8.3
Fondaparinux 2.5 mg2.2

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Number of Transfused Participants

The number of participants who received RBCs or WB after the total hip replacement surgery within 48 hours of bleed were reported. (NCT00320398)
Timeframe: Up to Day 17.

Interventionparticipants (Number)
Fondaparinux 1.5 mg5
Fondaparinux 2.5 mg2

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Volume of Transfusion

The total volume of transfusion (RBCs or WB) received by the participant was reported. (NCT00320398)
Timeframe: Up to Day 17

InterventionmL (Mean)
Fondaparinux 1.5 mg400.0
Fondaparinux 2.5 mg600.0

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Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) and Deaths

An AE was any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e. lack of efficacy), abuse or misuse. SAE was any experience that: resulted in death, was life-threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was medically significant. (NCT00320398)
Timeframe: From first injection of study drug (Day 3) to up to 2 calendar days after last injection (Treatment period), up to Day 17.

,
Interventionparticipants (Number)
DeathsAny SAEAny AE
Fondaparinux 1.5 mg0049
Fondaparinux 2.5 mg0045

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Percentage of Participants With Major Bleeding

Major bleeding defined as any clinically unusual bleeding meeting 1 of following criteria; a)Fatal bleeding; b) Including retroperitoneal and intracranial bleeding, or bleeding into critical organ (eye, adrenal gland, pericardium, spine); c) Reoperation due to bleeding or hematoma at operative site; d)Bleeding leading to hemoglobin (Hb) fall > = 2 gram per deciliter (g/dL)(1.6 millimole per litre [mmol/L]) within 48 hour of the bleed; e)Bleeding that required transfusion of red blood cells (RBCs) or whole blood (WB) derived from >= 900 milliliter (mL) of WB within 48 hours of the bleed (excluding autologous transfusion except for treatment of bleeding adverse event); f) Bleeding leading to bleeding index (BI) >=2. The percentage was calculated by the number of events divided by the number of participants evaluated multiplied by 100. This was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage of participants (Number)
Fondaparinux 1.5 mg0
Fondaparinux 2.5 mg0

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Percentage of Participants With Distal Only DVT

The percentage of participants with distal only DVT were reported, by using a venogram. It was calculated by the number of events divided by the number of participants evaluated multiplied by 100. The Venogram was obtained post 2 calendar days after the administration of last study drug (between Day 11 and 17). Day 1 was the day of surgery and the participant was given study drug 24±2 hours after surgical closure. It was adjudicated by the CIACE. (NCT00320398)
Timeframe: Up to Day 17

Interventionpercentage participants (Number)
Fondaparinux 1.5 mg4
Fondaparinux 2.5 mg1

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Rate of Symptomatic DVT

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. (NCT00320424)
Timeframe: Up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.0

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Rate of Proximal DVT During Treatment Period

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. (NCT00320424)
Timeframe: Up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.2.6

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Rate of PE During Treatment Period

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity PE: pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. (NCT00320424)
Timeframe: Up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.0

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Rate of Major Bleeding During Treatment Period

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of venous thromboembolic events (VTE) included, but were not limited to lower extremity deep vein thrombosis (DVT): erythema, warmth, pain, swelling, tenderness and pulmonary embolism (PE): pleuritic chest pain, dyspnea, cough, hemoptysis, syncope, light-headedness/dizziness, tachypnea, and tachycardia. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00320424)
Timeframe: From the first study drug injection up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.21.6

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Rate of DVT During Treatment Period

Rate (%) was defined as number of events divided by the number of patients evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. (NCT00320424)
Timeframe: Up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.21.6

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Rate of Distal Only DVT During Treatment Period

Rate (%) was defined as number of events divided by the number of participants evaluated multiplied by 100. Signs and symptoms suggestive of VTE included, but were not limited to lower extremity DVT: erythema, warmth, pain, swelling, tenderness. Intended treatment period started 24±2 hours after surgical closure. Venogram was obtained not later than 2 calendar days after the last study drug administration (between Day 11 and 17). These events were adjudicated by the CIACE. It was evaluated from the first study drug injection up to Day 17 or to first venogram, whichever occurred first. (NCT00320424)
Timeframe: Up to Day 17

Intervention% of normalized events per participant (Number)
Fondaparinux Sodium 2.5 mg s.c.21.6

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Number of Transfused Participants

Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. (NCT00320424)
Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

InterventionParticipants (Count of Participants)
Fondaparinux Sodium 2.5 mg s.c.1

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Number of Participants With Major Bleeding During Treatment Period

Major bleeding events were defined as clinically unusual bleeding meeting any of the following criteria: fatal bleeding, bleeding including retroperitoneal and intracranial bleeding or bleeding into a critical organ (eye, adrenal gland, pericardium, spine), reoperation due to bleeding/hematoma at the operative site, bleeding leading to a hemoglobin (Hb) fall >=2 grams per deciliter (g/dL, 1.6 millimoles per liter [mmol/L]) within 48 hour of the bleed, bleeding that required a transfusion of red blood cell or whole blood derived from >=900 millilters (mL) of whole blood within 48 hours of the bleed (excluding the autologous transfusion except for the treatment of bleeding adverse event (AE) and bleeding leading to the bleeding index (BI) >=2. Major bleeding events were adjudicated by the Central Independent Adjudication Committee of Safety (CIACS). (NCT00320424)
Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

InterventionParticipants (Count of Participants)
Fondaparinux Sodium 2.5 mg s.c.0

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Summary of Units Transfused

Blood product transfusions consisted of packed red blood cells or fresh frozen plasma or both. This was done between Day 2 and 2 calendar days after the last injection. (NCT00320424)
Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

InterventionmL (Number)
Fondaparinux Sodium 2.5 mg s.c.280

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Number of Participants With Minor Bleeding and Any Bleeding (Major and/or Minor Bleeding)

Minor bleeding and any bleeding (major and/or minor bleeding) events were adjudicated by the CIACS. Minor bleeding was defined as clinically overt bleeding not meeting the criteria for major bleeding and considered more than expected in the clinical context. Any bleeding (major and/or minor bleeding) could be recorded may be major and/or minor. (NCT00320424)
Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

InterventionParticipants (Count of Participants)
Minor BleedingAny Bleeding
Fondaparinux Sodium 2.5 mg s.c.00

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Number of Participants With Adverse Events (AE), Serious Adverse Events (SAE) and Death

An AE was defined as any untoward medical occurrence (MO) in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP and can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with its use. The SAE was any untoward MO that, at any dose, results in death, life threatening, persistent or significant disability/incapacity, results in or prolongs inpatient hospitalization, congenital abnormality or birth defect, that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition. (NCT00320424)
Timeframe: From the first study drug injection up to 2 days after the last study drug injection (approximately up to Day 17)

InterventionParticipants (Count of Participants)
Any AEAny SAEDeath
Fondaparinux Sodium 2.5 mg s.c.3720

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Number of Patients With Venous Thromboembolism at Week 4

Venous thromboembolism is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. (NCT00381888)
Timeframe: Week 4 (Days 28-35)

InterventionParticipants (Number)
Fondaparinux Patients Who Completed Study0

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Number of Patients Who Achieved Thromboembolism Prophylaxis at Week 4.

This is a count of patients who did not have a clot (thromboembolism) occur during the 4 weeks of study - attributed to the use of Fondaparinux (study dry). Prophylaxis is a measure taken for the prevention of a disease or condition. (NCT00381888)
Timeframe: Week 4

InterventionParticipants (Number)
Fondaparinux Patients Who Completed Study27

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Adverse Events

Adverse events will be defined as any untoward or unexpected event which can be a symptom, physical exam sign or laboratory abnormality. Adverse events will be classified as serious if they lead to prolonged hospitalization, re-hospitalization, transfer to an intensive care unit, or death. Adverse events will be categorized in terms of their likely association with fondaparinux as probably related, possibly related, unrelated, or unknown, and will be recorded according to standard adverse reporting guidelines for clinical trials. (NCT00412464)
Timeframe: Study period which was up to 21 days of fondaparinux

InterventionAdverse Events (Number)
Fondaparinux Group0

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Bleeding Events

Bleeding assessment Patients will be monitored for bleeding symptoms by physician and nursing assessment. Major bleeding will be defined as bleeding which is in a critical space (intracranial, retroperitoneal, or visceral) or leads to the need for blood transfusion. Minor bleeding will be all other bleeding and will be classified as clinically significant (i.e. If the physician has to take action to treat the minor bleed) or clinically insignificant (i.e. if the physician does not need to intervene to treat the minor bleed). (NCT00412464)
Timeframe: Study period which was up to 21 days of fondaparinux

InterventionAdverse Events (Number)
Fondaparinux Group2

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Number of Abnormal Lab Results Resulting in Adverse Events.

The primary outcome measure was assessment of safety by reporting the number of abnormal lab results resulting in adverse events. Safety laboratory assessments are as follows: Liver and kidney toxicity will be determined by serial measurements of AST, ALT, total bilirubin, BUN and creatinine. Hematologic toxicity will be assessed by serial CBCs. (NCT00412464)
Timeframe: Study period which was up to 21 days of fondaparinux

InterventionAdverse Events (Number)
Fondaparinux Group0

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Therapeutic Plasma Concentration of Fondaparinux at 21 Days

Subjects all had detailed pharmacokinetic measurements done which were subsequently analyzed in a population pharmacokinetic model. This model then informed the dosing recommendations that were published as a result of the study. (NCT00412464)
Timeframe: 21 days

Interventionmg/dL (Mean)
Fondaparinux Group24

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Thrombocytopenic Events

Patient's platelet counts should be kept above 50 x 10^9/L while on study with platelet transfusions as needed with the exception of patients enrolled under the HIT/ suspicion of HIT inclusion (platelet transfusions are contraindicated in HIT). With regards to study patients who experience progressive decreases in platelet count to below 50 x 10^9/L while receiving fondaparinux (excluding patients being treated for HIT or suspicion of HIT), fondaparinux will be discontinued. (NCT00412464)
Timeframe: Study period which was up to 21 days of fondaparinux

InterventionAdverse Events (Number)
Fondaparinux Group0

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Resolution of PE

(NCT00423683)
Timeframe: 3 years or until death

Interventionpercentage of PE sites (Number)
Arm 1 Arixtra32.0
Arm 2 Arixtra + IVC Filter66.7

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Resolution of DVT

(NCT00423683)
Timeframe: 3 years or until death

Interventionpercentage of DVT sites (Number)
Arm 1 Arixtra61.0
Arm 2 Arixtra + IVC Filter37.5

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Overall Survival

(NCT00423683)
Timeframe: 3 years or until death

Interventiondays (Median)
Arm 1 Arixtra493
Arm 2 Arixtra + IVC Filter266

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Adverse Outcomes

Rates of VCF complications, bleeding, and recurrent or residual DVTs or PEs (NCT00423683)
Timeframe: 3 years or until death

Interventionpercentage of participants (Number)
Arixtra15.2
Arixtra and Filter16.1

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Number of Participants With at Least One Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 77

VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment. (NCT00443053)
Timeframe: Baseline to Day 77

Interventionparticipants (Number)
Fondaparinux 2.5 mg18
Placebo94

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Number of Adjudicated Major Bleeding Events and Deaths at Days 47 and 77

"Major bleeding was defined as bleeding that was fatal and/or (1) in a critical area/organ (e.g., intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome); (2) associated with a fall in hemoglobin >=20 g/L (1.24 mmol/L); (3) led to a transfusion of >=2 units of packed red blood cells/whole blood. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days." (NCT00443053)
Timeframe: Days 47 (or last dose plus 4 days) and 77

,
Interventionevents (Number)
Major bleeding events, Day 47Deaths, Day 47Major bleeding events, Day 77Deaths, Day 77
Fondaparinux 2.5 mg1212
Placebo1111

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Number of Adjudicated Non-Major Bleeding Events at Days 47 and 77

"Clinically relevant non-major bleeding was defined as clinically relevant bleeding that did not qualify as major but satisfied a priori criteria, and/or any bleeding that resulted in clinical consequences for a participant. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days." (NCT00443053)
Timeframe: Days 47 (or last dose plus 4 days) and 77

,
Interventionevents (Number)
Day 47Day 77
Fondaparinux 2.5 mg56
Placebo89

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Number of Any Adjudicated Bleeding Events at Days 47 and 77

"The sum of adjudicated major bleeds, non-major clinically relevant bleeds, and minor bleeds was calculated. Minor bleeding was defined as other clinically overt bleeding events that did not meet the criteria for major or clinically relevant non-major bleeding. The revision of the Day 47 time point was to account for participants with treatment duration longer than 45 days. Adverse events were evaluated On-Treatment, defined as from randomization up to the last injection +4 days." (NCT00443053)
Timeframe: Days 47 (or last dose plus 4 days) and 77

,
Interventionevents (Number)
Day 47Day 77
Fondaparinux 2.5 mg1516
Placebo1415

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Number of Participants Who Required Surgery to Treat Superficial Vein Thrombosis Recurrence at Days 47 and 77

The number of participants requiring surgery was measured. (NCT00443053)
Timeframe: Days 47 and 77

,
Interventionparticipants (Number)
Day 47Day 77
Fondaparinux 2.5 mg1115
Placebo5761

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Number of Participants With at Least One Occurrence of Each Adjudicated Component of the Primary Efficacy Endpoint at Days (D) 47 and 77

VTE was defined as a composite of symptomatic DVT; symptomatic PE; symptomatic extension of SVT, defined as downstream progression of the initial SVT by at least 2 cm and to within <=3 cm from the sapheno-femoral junction; or symptomatic recurrence of SVT, defined as a new episode in any other superficial venous location, meeting the following criteria: the new SVT was in a different superficial vein and not directly contiguous upstream with the index SVT, or it was in the same superficial vein but clearly distinct from the index SVT with an open venous segment of at least 10 cm in length. (NCT00443053)
Timeframe: Days 47 and 77

,
Interventionparticipants (Number)
Participants with at least one event, D 47Death, D 47Symptomatic PE, D 47Symptomatic DVT, D 47Symptomatic recurrence of SVT, D 47Symptomatic extension of SVT, D 47Participants with at least one event, D 77Death, D 77Symptomatic PE, D 77Symptomatic DVT, D 77Symptomatic recurrence of SVT, D 77Symptomatic extension of SVT, D 77
Fondaparinux 2.5 mg13203541820485
Placebo88151824519416192654

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Number of Participants With at Least on Event of Venous Thromboembolism (VTE) and/or Death From Any Cause Recorded up to Day 47

VTE was defined as a composite of symptomatic deep-vein thrombosis (DVT), symptomatic pulmonary embolism (PE), symptomatic extension of superficial vein thrombosis (SVT), or symptomatic recurrence of SVT. All VTEs were confirmed by objective tests and then adjudicated by an independent central adjudication committee (CAC), whose members were blinded to treatment assignment. (NCT00443053)
Timeframe: Baseline to Day 47

Interventionparticipants (Number)
Fondaparinux 2.5 mg13
Placebo88

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The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Characterized as Fatal bleed, Major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after Fondaparinux administration, prior to randomization

Interventionparticipants (Number)
Heparin0
Bivalirudin0

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The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Categorized as Fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after randomization, during PCI

Interventionparticipants (Number)
Heparin0
Bivalirudin0

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Secondary in Hospital Endpoint Will be In-hospital Death (Non-hemorrhagic Related), Vascular Access Site Complications, Myocardial Infarction, Need for Repeat Revascularization, Procedural Complication and Catheter Thrombosis

Characterized as death, access site complication, access site thrombus, hematoma, myocardial infarction, repeat vascularization, dissection, stent thrombosis, catheter thrombosis (NCT00464087)
Timeframe: during index hospitalization

Interventionparticipants (Number)
Heparin4
Bivalirudin4

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The Primary Endpoint Will be in Hospital Major Bleed as Defined by the Study Protocol, Assessed at Three Time Points: After Study Drug Administration, But Prior to Randomization;After Randomization During PCI; and After PCI, Prior to Discharge

Characterized as fatal bleed, major bleed (SWITCH III criteria) or major bleed (OASIS criteria) (NCT00464087)
Timeframe: During hospitalization, after PCI

Interventionparticipants (Number)
Heparin0
Bivalirudin1

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Presence of Deep Vein Thrombosis (DVT) or Pulmonary Embolus (PE)

Color-flow duplex venous ultrasonography examinations of upper and lower extremities were performed within 48 hours of injury, and then weekly until discharge or 3 weeks. DVT was defined as any clot occurring in the subclavian, iliac, femoral, or popliteal location. Patients were examined daily for clinical signs and symptoms of venous thromboembolism (VTE) and PE. Small, nonocclusive clots discovered in other locations were observed for progression on sequential ultrasonography examinations. (NCT00531843)
Timeframe: within 3 weeks post injury

,
Interventionparticipants (Number)
DVTDVT after fondaparinuxPE
Fondaparinux Sodium210
No Fondaparinux2NA0

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Normal Trough and Peak Fondaparinux Concentration

Serum samples were collected 30 minutes before (trough) and 2 hours after (peak) the third dose of fondaparinux. Normative data plots comparing study participants with healthy volunteers were supplied by the company outsourced to analyze samples. (NCT00531843)
Timeframe: Day 3

InterventionParticipants (Number)
Trough values outside normative rangePeak values outside normative range
Fondaparinux Sodium00

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Increased Bleeding Attributed to Fondaparinux

Coagulopathic bleeding due to fondaparinux was suspected in patients requiring packed red cell transfusions after initiation of fondaparinux therapy only if the change in hematocrit prompting transfusion was not clinically commensurate with the degree of injuries that the patient had sustained (primarily orthopaedic) and/or the hematocrit did not respond appropriately post-transfusion. (NCT00531843)
Timeframe: 3 weeks post injury

Interventionparticipants (Number)
Fondaparinux Sodium0

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Incidence of Untoward Effects With Arixtra

Adverse events will be evaluated to determine untoward effects. (NCT00539942)
Timeframe: 21 days

Interventionparticipants (Number)
Intermittent Compression Devices0
Arixtra (Fondaparinux Sodium)0

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Comparison of Deep Venous Thromboembolism (DVT) Using Intermittent Compression Devices With and Without Arixtra

Deep venous thromboembolism (DVT) rates are determined from lower extremity doppler ultrasound measurements. (NCT00539942)
Timeframe: 21 days

Interventionparticipants (Number)
Intermittent Compression Devices4
Arixtra (Fondaparinux Sodium)3

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Number of Patients With Major Bleedings at 1 Month ± 5 Days.

evaluate the number of patients affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L at 1 month ± 5 days. (NCT00555438)
Timeframe: 45 day

Interventionparticipants (Number)
Fondaparinux 1.5 mg/l23

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Death at 1 Month ± 5 Days

Evaluate the total number of death at 1 month ± 5 days (NCT00555438)
Timeframe: 1 month ± 5 days

Interventionparticipants (Number)
Fondaparinux 1.5 mg/l10

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Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism Between Day 1 and Day 10

Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) between Day 1 and Day 10. (NCT00555438)
Timeframe: 10 days

Interventionparticipants (Number)
Fondaparinux 1.5 mg/l2

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Number of Patients With Symptomatic Deep Vein Thrombosis and Pumonary Embolism at 1 Month ± 5 Days

Evaluate the number of patients affected by symptomatic Deep Vein Thrombosis (any symptomatic distal and/or proximal deep-vein thrombosis) and Pumonary Embolism (symptomatic pulmonary embolism confirmed by objective tests) at 1 month ± 5 days. (NCT00555438)
Timeframe: at 1 month ± 5

Interventionparticipants (Number)
Fondaparinux 1.5 mg/l3

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Number of Patients With Major Bleedings Between Day 1 and Day 10.

evaluate between Day 1 and Day 10, the number of patients under study treatment who has affected by major bleedings defined as fatal, involved a critical organ, treatment cessation, occurred at the surgical site and necessitated any medical intervention, or if it was overt and necessitated transfusion of >2 units of packed red blood cells or was associated with a fall in hemoglobin >20 g/L. (NCT00555438)
Timeframe: 10 day

Interventionparticipants (Number)
Fondaparinux 1.5 mg/l20

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the Incidence of Venous or Thrombotic Events After Starting Treatment With Fondaparinux

(NCT00673439)
Timeframe: 4 weeks after INR reaches 2 or more

InterventionParticipants (Count of Participants)
Fondaparinux0

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Number of Participants Showing Clinically Significant Bleeding

Clinically significant bleed is defined as Hemodynamically Significant Bleeding or Requiring Blood Transfusions While Being Treated With Fondaparinux (NCT00673439)
Timeframe: 4 weeks after INR reaches 2 or more

Interventionparticipants (Number)
Fondaparinux0

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Number of Participants With Venous Thromboembolisms and/or Major Hemorrhages to Day 11

there were 2 events; one in placebo group and one in fondaparinux group (NCT00789399)
Timeframe: 11 days

InterventionParticipants (Count of Participants)
Fondaparinux1
Placebo1

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Number of Participants With a Venous Thromboembolisms to 35 Days

(NCT00789399)
Timeframe: 35 days

InterventionParticipants (Count of Participants)
Fondaparinux1
Placebo1

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Number of Participants With Composite of Major Bleeding, Minor Bleeding, or Major Vascular Access Site Complications During the Peri-PCI Period

The peri-percutaneous coronary intervention (peri-PCI) period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major and minor bleeding events were adjudicated by a blinded central independent adjudication committee (CIAC). Major vascular access site complications comprised large hematoma, pseudoaneurysm requiring treatment, aterio-venous fistula, or other vascular procedures related to the access site. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Interventionparticipants (Number)
OL Fondaparinux Background + Low Dose UFH During PCI48
OL Fondaparinux Background + Standard Dose UFH During PCI58

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Number of Participants With Composite of Major Bleeding During the Peri-PCI Period, With Death, MI, or TVR at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, myocardial infarction (MI) and target vessel revascularisation (TVR) was performed at Day 30. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI period for major bleeding (during the time from randomization up to 48 hours after the end of PCI [typically 49 hours total] ) and from randomization up to Day 30 for death, MI, or TVR

Interventionparticipants (Number)
OL Fondaparinux Background + Low Dose UFH During PCI59
OL Fondaparinux Background + Standard Dose UFH During PCI39

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Number of Participants With Major Bleeding During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major bleeding, MI and TVR were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Interventionparticipants (Number)
OL Fondaparinux Background + Low Dose UFH During PCI14
OL Fondaparinux Background + Standard Dose UFH During PCI12

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Number of Participants With Major Vascular Access Site Complications During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Major vascular access site complications included: large hematoma, pseudoaneurysm requiring treatment, arterio-venous fistula, or other vascular procedures related to the access site. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Interventionparticipants (Number)
OL Fondaparinux Background + Low Dose UFH During PCI33
OL Fondaparinux Background + Standard Dose UFH During PCI43

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Number of Participants With Minor Bleeding During the Peri-PCI Period

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Minor bleeding events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI Period: occurred at randomization (from randomization to 48 hours after end of PCI procedure, typically 49 hours total)

Interventionparticipants (Number)
OL Fondaparinux Background + Low Dose UFH During PCI7
OL Fondaparinux Background + Standard Dose UFH During PCI17

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Number of Participants Experiencing Death, MI, TVR, Definite/Probable Stent Thrombosis, or Stroke, Assessed Separately During the Peri-PCI Period and at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of death, MI, TVR, definite/probable stent thrombosis, or stroke was performed during the peri-PCI period and at Day 30. MI, TVR, definite/probable stent thrombosis, and stroke events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

,
Interventionparticipants (Number)
Death during peri-PCI periodMI during peri-PCI periodTVR during peri-PCI periodDefinite/Probable Stent Thrombosis during peri-PCIStroke during peri-PCIDeath at Day 30MI at Day 30TVR at Day 30Definite/Probable Stent Thrombosis at Day 30Stroke at Day 30
OL Fondaparinux Background + Low Dose UFH During PCI1203138319125
OL Fondaparinux Background + Standard Dose UFH During PCI216225625355

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Number of Participants With Composite of Death, MI or TVR During the Peri-PCI Period and at Day 30

The peri-PCI period was defined as the period during the time from randomization up to 48 hours after the end of the PCI procedure, typically 49 hours total. Assessment of composite of death, MI, or TVR was performed both during the peri-PCI period and at Day 30. MI and TVR events were adjudicated by a blinded CIAC. (NCT00790907)
Timeframe: Peri-PCI (during the time from randomization up to 48 hours after the end of PCI, typically 49 hours total) and from randomization up to Day 30

,
Interventionparticipants (Number)
Composite of death, MI, and TVR Peri-PCIComposite of death, MI, and TVR at Day 30
OL Fondaparinux Background + Low Dose UFH During PCI2346
OL Fondaparinux Background + Standard Dose UFH During PCI1929

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Number of Participants With Confirmed VTE and Death up to the Final Visit or Contact

The number of participants with VTE (defined as asymptomatic deep vein thrombosis [DVT: the formation of a blood clot in a deep vein] detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism [PE]) and death was assessed. An embolism is a clot in the blood that forms and blocks a blood vessel. A PE is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. (NCT00843492)
Timeframe: Day 1 to 5 weeks (plus or minus 1 week) after complete mobilization (average of 67.8 study days)

Interventionparticipants (Number)
Nadroparin49
Fondaparinux15

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Number of Participants With Minor Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

,
Interventionparticipants (Number)
Up to complete mobilization plus 4 daysUp to the final visit or contact
Fondaparinux99
Nadroparin33

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Participants With Any Incidence of Any Bleeding Event as Adjudicated by a CAC) From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

All episodes of bleeding, except minor bruising, skin hematomas not greater than 5 centimeters in diameter, self-limited epistaxis (bleeding through the nose), and self-limited gingival (gum) bleeding, were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

,
Interventionparticipants (Number)
Up to complete mobilization plus 4 daysUp to the final visit or contact
Fondaparinux1111
Nadroparin67

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Number of Participants With Major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

Major bleeding is defined as bleeding that results in a fatality, symptomatic bleeding in a critical area or organ, bleeding causing a fall in hemoglobin level of 20 grams/liter (1.24 millimoles/liter) or more compared with the pre-randomization hemoglobin level, or bleeding that leads to a transfusion of two or more units of whole blood or red blood cells. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

,
Interventionparticipants (Number)
Up to complete mobilization plus 4 daysUp to the final visit or contact
Fondaparinux11
Nadroparin00

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Number of Participants With Clinically Relevant Non-major Bleeding From Day 1 to Complete Mobilization and From Day 1 up to the Final Visit or Contact

Clinically relevant non-major bleeding that does not qualify as major is defined as bleeding leading to treatment discontinuation, and/or epistaxis (bleeding through the nose) that lasts for more than 5 minutes or necessitates intervention (e.g., packing), spontaneous macroscopic haematuria (blood in urine), gastrointestinal haemorrhage, haemoptysis (coughing up blood), or subcutaneous haematoma (localized collection of blood) > 100 centimeters squared. All episodes of bleeding were adjudicated by an independent CAC. The committee members were unaware of the participants' treatment assignment. (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 4 days (average of 37.7 study days); Day 1 up to final visit or contact (average of 66.3 study days)

,
Interventionparticipants (Number)
Up to complete mobilization plus 4 daysUp to the final visit or contact
Fondaparinux11
Nadroparin34

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Number of Participants With Any Adjudicated Components of VTE, Asymptomatic DVT, Symptomatic DVT, Symptomatic PE, and Death

All components of the primary endpoint were considered separately: any VTE; symptomatic (providing no evidence of disease existence) DVT (the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography; symptomatic(providing evidence of disease existence) DVT; symptomatic PE (blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung of one of its branches); and death. (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 2 days (average of 35.7 study days)

,
Interventionparticipants (Number)
Any VTE, n=586, 583Any asymptomatic DVT, n=585, 582Any symptomatic DVT, n=622, 621Any symptomatic PE, n=622, 621Death, n=622, 621
Fondaparinux1411221
Nadroparin4842700

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Number of Participants With Venous Thromboembolism (VTE) or Death up to the Time of Complete Mobilization

VTE is defined as asymptomatic deep vein thrombosis (DVT: the formation of a blood clot in a deep vein) detected by systematic compression ultrasonography, symptomatic DVT, or symptomatic fatal or non-fatal pulmonary embolism (PE). An embolism is a clot in the blood that forms and blocks a blood vessel. A pulmonary embolism is a blood clot that has travelled from elsewhere in the body through the blood stream to block the main artery of the lung or one of its branches. All venous thromboembolic events and deaths were adjudicated by the independent Central Adjudication Committee (CAC). (NCT00843492)
Timeframe: Day 1 to complete mobilization plus 2 days (average of 35.9 study days)

Interventionparticipants (Number)
Nadroparin48
Fondaparinux15

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Number of Days Until a Dry Wound

Days from day of surgery to stoppage of leakage from the wound (NCT00909064)
Timeframe: Up to 10 days

Interventiondays (Mean)
Arixtra3.6

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Incidence of Wound Infection

Incidence of Cellulitis in patients undergoing Arixtra treatment (NCT00909064)
Timeframe: Up to 10 days

InterventionParticipants (Count of Participants)
Arixtra2

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Number of Days in Hospital.

Days after surgery to dischage (NCT00909064)
Timeframe: Up to 10 days

Interventiondays (Mean)
Arixtra3.73

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Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic VTE (by Type)

VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the CIACE. (NCT00911157)
Timeframe: From Day 1 to Day 90 (±7 days)

,
Interventionpercentage of participants (Number)
Symptomatic DVT only(Symptomatic) Non-fatal PE(Symptomatic) Fatal PEAsymptomatic DVT onlyAsymptomatic PE
Fondaparinux Sodium (FPX)0003.60
Unfractionated Heparin (UFH)00000

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Total Perfusion Score at Baseline and Mean Change From Baseline at Day 5-10

Change from baseline was calculated as the score on the day medication was finished/discontinued (anywhere from Day 5 to Day 10) minus the baseline score. The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the CIACE. Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). (NCT00911157)
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

,
Interventionpoints on a scale (Mean)
BaselineChange from Baseline
Fondaparinux Sodium (FPX)0.9440.015
Unfractionated Heparin (UFH)0.9590.004

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Percentage of Participants With a Bleeding Event

Bleeding events (major bleeding [clinically overt bleeding with fatality, location in a critical organ, a fall in hemoglobin >=2 grams (g)/deciliter (dL), or a transfusion >=2 units]; minor bleeding [clinically overt bleeding and not adjudicated as major bleeding], and no bleeding) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). (NCT00911157)
Timeframe: Initial treatment period (from the first dose of FPX/UFH to N days after the last dose of FPX/UFH; specified based on creatinine clearance [CLcr]; N=3, CLcr >=50 mL/min; N=4, 30 =< CLcr < 50 mL/min; N=9, CLcr < 30 mL/min).

,
Interventionpercentage of participants (Number)
Major bleedingMinor bleeding onlyAny bleeding (major and/or minor bleedings)
Fondaparinux Sodium (FPX)3.43.46.9
Unfractionated Heparin (UFH)000

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Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)

VTE (pulmonary thromboembolism [PE] and/or deep vein thrombosis [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00911157)
Timeframe: From Day 1 to Day 90 (±7 days)

Interventionpercentage of participants (Number)
Fondaparinux Sodium (FPX)0
Unfractionated Heparin (UFH)0

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Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse Compared to Baseline

"Classifications of Improved, No change, or Worse were adjudicated blindly by the CIACE." (NCT00911157)
Timeframe: Baseline, single day between Day 5 and Day 10 (the day when the medication [FPX or UFH] was finished /discontinued) (±1 day)

,
Interventionpercentage of participants (Number)
ImprovedNo ChangeWorse
Fondaparinux Sodium (FPX)18.581.50
Unfractionated Heparin (UFH)11.188.90

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Number of Thrombus-negative and Thrombus-positive Participants With Conversion to Sinus Rhythm

Sinus rhythm is the normal beating of the heart, as measured by an ECG. Normal sinus rhythm not only indicates that the rhythm is normally generated by the sinus node and is traveling in a normal fashion in the heart, but it also indicates that the heart rate (the rate at which the sinus node is generating impulses) is within normal limits. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Day 64 until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Clot-negative par. until 4 days after EOTClot-positive par. until 4 days after EOTClot-negative participants until the FUClot-positive participants until the FU
Fondaparinux10951054
UFH/VKA11541065

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Number of Thrombus-negative and Thrombus-positive Participants With at Least One Systemic Thromboembolism

Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All systemic thromboembolic events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Thrombus-negative par. until 4 days after EOTThrombus-positive par. until 4 days after EOTThrombus-negative participants until the FUThrombus-positive participants until the FU
Fondaparinux0000
UFH/VKA0000

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Number of Thrombus-negative and Thrombus-positive Participants With at Least One Major Bleeding Event

Major bleeding: fatal, and/or symptomatic in a critical area/ organ, causes a fall in hemoglobin of >=3 grams/deciliter compared with the pre-randomization level, or leads to the transfusion of >=2 units of whole blood/red blood cells. All bleeding events were adjudicated by a CAC, the members of which were unaware of the participants' treatment assignment. A thrombus/ blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Thrombus-negative par. until 4 days after EOTThrombus-positive par. until 4 days after EOTThrombus-negative participants until the FUThrombus-positive participants until the FU
Fondaparinux3040
UFH/VKA1010

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Number of Thrombus-negative and Thrombus-positive Participants Who Died From Any Cause

The cause of death was classified as due to a thromboembolic event (like cerebral infarction), bleeding, or other established diagnosis, or as unexplained. All deaths were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Thrombus-negative par. until 4 days after EOTThrombus-positive par. until 4 days after EOTThrombus-negative participants until the FUThrombus-positive participants until the FU
Fondaparinux1030
UFH/VKA0000

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Number of Thrombus-negative and Thrombus-positive Participants (Par.) With at Least One Cerebral Neurologic Event

Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolisation, e.g., TIA, cerebral infarction. All cerebral neurologic events were adjudicated by a CAC, members of which were unaware of the participants' treatment assignment.The cerebrovascular origin of the event was confirmed by objective procedures. A thrombus or blood clot is the final product of the blood coagulation step in hemostasis. It is achieved via the aggregation of platelets that form a platelet plug, and the activation of the humoral coagulation system (i.e., clotting factors). (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Thrombus-negative par. until 4 days after EOTThrombus-positive par. until 4 days after EOTThrombus-negative participants until the FUThrombus-positive participants until the FU
Fondaparinux0010
UFH/VKA1010

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Number of Participants Who Were Re-hospitalized

Hospitalization signifies that the participant has been detained (usually involving at least an overnight stay) at the hospital or emergency ward for observation and/or treatment that would not have been appropriate in the physician's office or out-patient setting. Re-hospitalization refers to an event of hospitalization after discharge for the initial hospitilization for the cardioversion. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
until 4 days after EOTuntil the FU
Fondaparinux1418
UFH/VKA711

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Number of Participants With Primary Successful Electrical Cardioversion (CV) in Sinus Rhythm

CV may be performed electively to restore sinus rhythm in patients with persistent AF. The primary successful electric CV was assessed by a 12- lead electrocardiogram (ECG) directly after the CV. Results of the last cardioversion were used in cases for which more than one CV was performed. (NCT00911300)
Timeframe: Day 1 until Day 3

Interventionparticipants (Number)
Fondaparinux137
UFH/VKA133

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Number of Participants With at Least One Event of Cerebral Neurologic Event, Systemic Thromboembolism, Death From Any Cause, and/or Major Bleeding Until the End of Treatment (EOT) Plus 4 Days

Cerebral neurologic events are defined as any new neurologic disorders caused by cerebrovascular embolization, e.g., Transient Ischemic Attack (TIA), cerebral infarction. The cerebrovascular origin of the event has to be confirmed by objective procedures. Systemic thromboembolism comprises any arterial thromboembolic event (e.g., peripheral vascular embolism, mesenteric infarct, or myocardial infarction). All cerebral neurologic events were adjudicated by a Central Adjudication Committee (CAC), members of which were unaware of the participants' treatment assignment. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants

Interventionparticipants (Number)
Fondaparinux3
UFH/VKA2

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Number of Participants With a Thrombus in the Left Atrium (LA) or in the Left Atrial Appendage (LAA) at the Time of the Second TEE

Atrial fibrillation (AF) causes stagnant blood in the LA or LAA and can lead to a thromboembolism. Stasis in the LAA represents the principal mechanism of thrombus formation in AF. (NCT00911300)
Timeframe: At second TEE (at Day 28+/-4)

Interventionparticipants (Number)
Fondaparinux3
UFH/VKA7

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Number of Thrombus-negative and Thrombus-positive Participants With at Least One Minor Bleeding Event

Minor bleeding is defined as clinically overt bleeding events that do not meet the criteria for major or clinically relevant non-major bleeding. All episodes of bleeding were adjudicated by an independent CAC, the members of which were unaware of the participants' treatment assignment. (NCT00911300)
Timeframe: Baseline (Day 1) until Day 64 (4 days after the EOT [i.e., last administration of study drug]) for CP participants; Baseline until Day 36 (4 days after the EOT) for CN participants; and from Baseline until the follow-up visit (FU) (Day 90+/-7)

,
Interventionparticipants (Number)
Thrombus-negative par. until 4 days after EOTThrombus-positive par. until 4 days after EOTThrombus-negative participants until the FUThrombus-positive participants until the FU
Fondaparinux3031
UFH/VKA4050

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The Percentage of Participants With Recurrent or New Symptomatic Venous Thromboembolism (VTE)

VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00981409)
Timeframe: From Day 1 to Day 90 (±7 days)

Interventionpercentage of participants (Number)
Fondaparinux Sodium (FPX)0
Unfractionated Heparin (UFH)0

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The Percentage of Participants With a Bleeding Event

Bleeding events (major bleeding [clinically overt bleeding with: fatality, location in critical organ, a fall in hemoglobin >=2 g/dL, or a transfusion >=2 units], minor bleeding [clinically overt bleeding and not adjudicated as major bleeding]) were adjudicated blindly by the Central Independent Adjudication Committee of Safety (CIACS). (NCT00981409)
Timeframe: FPX or UFH treatment period (Days 5-10, on average)

,
Interventionpercentage of participants (Number)
Major bleeding onlyMinor bleedingAny bleeding (major and/or minor bleeding)
Fondaparinux Sodium (FPX)09.79.7
Unfractionated Heparin (UFH)000

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The Percentage of Participants With Recurrent or New Symptomatic/Asymptomatic Venous Thromboembolism (VTE) (by Type)

VTE (pulmonary thromboembolism [PE] and/or deep vein thromboembolism [DVT]) was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). (NCT00981409)
Timeframe: From Day 1 to Day 90 (±7 days)

,
Interventionpercentage of participants (Number)
Symptomatic DVT only(Symptomatic) Non-fatal PE(Symptomatic) Fatal PEAsymptomatic DVT onlyAsymptomatic PE
Fondaparinux Sodium (FPX)00000
Unfractionated Heparin (UFH)00000

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Total Perfusion Score at Baseline and Mean Change From Baseline at Days 5-10

The perfusion score (0: no perfusion; 0.25, 0.5, 0.75, 1: normal) in each of the six lobes of the lung was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Total perfusion score (r) was calculated as: r = (0.25 x right lower lobe) + (0.12 x right middle lobe) + (0.18 x right upper lobe) + (0.20 x left lower lobe) + (0.12 x lingula) + (0.13 x left upper lobe). (NCT00981409)
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

,
Interventionpoints on a scale (Mean)
BaselineChange from baseline, Days 5-10 (+/-1)
Fondaparinux Sodium (FPX)0.6540.101
Unfractionated Heparin (UFH)0.5860.185

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The Percentage of Participants With Perfusion Lung Scan Results Scored as Improved, no Change, or Worse

"Improved, No change, or Worse was adjudicated blindly by the Central Independent Adjudication Committee of Efficacy (CIACE). Each category is adjudicated by comparison with the perfusion score at baseline by the CIACE." (NCT00981409)
Timeframe: Baseline, Days 5-10 (the day when the medication [FPX or UFH] was finished /discontinued) (+/-1)

,
Interventionpercentage of participants (Number)
ImprovedNo changeWorse
Fondaparinux Sodium (FPX)78.621.40
Unfractionated Heparin (UFH)90.010.00

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Mean Head Circumference of Newborn

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventioncentimeters (Mean)
Fondaparinux34

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Mean Height of Newborn

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventioncentimeters (Mean)
Fondaparinux49.6

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Mean Weight of Newborn

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiongrams (Mean)
Fondaparinux3042

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Number of Hours After Birth at Which Fondaparinux Administration Was Restarted

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionhours (Mean)
Fondaparinux11.3

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Number of Hours Before Birth That the Last Fondaparinux Dose Was Administered

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionhours (Mean)
Fondaparinux34.6

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"Number of Newborns Who Had a Healthy Postnatal Classification"

"A healthy documentation was based on the investigators' individual assessment." (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionnewborns (Number)
Missing dataHealthyNot healthy
Fondaparinux101104

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Duration of Hospitalizations Before, During, and After Fondaparinux Administration

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Before Fondaparinux, n=3During Fondaparinux, n=5After Fondaparinux, n=1
Fondaparinux1052

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Mean APGAR Score at 1, 5, and 10 Minutes After Birth

APGAR is a test performed by a doctor, midwife, or nurse at 1 and 5 minutes after birth. The 1-minute score determines how well the baby tolerated the birthing process; the 5-minute score assesses how well the newborn is adapting to the new environment. The health care provider examines the baby's breathing effort, heart rate, muscle tone, reflexes, and skin color. Each category is scored with 0 (worst score), 1, or 2 (best score), depending on the observed condition. The rating is based on a total score of 1-10, with 10 suggesting the healthiest infant. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionscores on a scale (Mean)
after 1 min, n=26after 5 min, n=27after 10 min, n=27
Fondaparinux8.69.19.6

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Number of Newborns With Abnormalities

No formal definition for abnormalities was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionnewborns (Number)
Missing dataNo abnormalities
Fondaparinux10114

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Number of Participants Administered the Indicated Dose of Fondaparinux Per Day

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Dose missing2.5 milligrams (mg)5 mg5 mg until delivery, followed by 2.5 mg7.5 mg10 mg
Fondaparinux29416134

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Number of Participants for Whom Fondaparinux Administration Was Interrupted for Birth

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Missing dataNot interruptedInterrupted
Fondaparinux92091

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Number of Participants Hospitalized Because of Thromboembolic Treatment

Thromboembolic treatment is a defined as prophylaxis for an elevated thromboembolic risk or therapeutic treatment of acute thromboembolism. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNot hospitalizedHospitalized
Fondaparinux12010218

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Number of Participants Receiving Fondaparinux in the Indicated Therapy Intervals

The prenatal interval is defined as the interval of time until 3 days before birth. The perinatal interval is defined as the interval of time from 2 days before birth to one day after birth. The postnatal interval is defined as the interval of time beginning 2 days after birth. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Prenatal onlyPerinatal onlyPostnatal onlyPrenatal and PerinatalPerinatal and PostnatalPrenatal and PostnatalPrenatal, Perinatal, and PostnatalUnknown
Fondaparinux6013129710

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Number of Participants Who Delivered a Single Child Versus Twins

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Single childTwins
Fondaparinux1164

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Number of Participants Who Exhibited Observed Skin Changes and Also Had Erythema Associated With the Skin Changes Under UFH/LMWH Therapy

Erythema is defined as inflammation of the skin, associated with reddening, and is a frequent side effect of heparins. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo erythema or missing dataErythema
Fondaparinux40436

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Number of Participants Who Exhibited Observed Skin Changes and Also Had Skin Necrosis Associated With the Skin Changes Under UFH/LMWH Therapy

Skin necrosis is defined as the dying off of skin area because of allergic reaction. Skin necrosis is a severe side effect of heparins. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo skin necrosis or missing dataSkin necrosis
Fondaparinux40328

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Number of Participants With and Without Complications Under Fondaparinux Therapy

A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, death, or other complication (as indicated by investigator). (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo complications or missing dataComplications
Fondaparinux1201119

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Number of Participants With Bleedings Under Fondaparinux Therapy

No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo bleedings or missing dataBleedings
Fondaparinux1201182

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Number of Participants With Bleedings Under UFH/LMWH Therapy

No formal definition for bleeding was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo bleeding or missing dataBleeding
Fondaparinux1201182

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Number of Participants With Complications Under UFH/LMWH Therapy

A complication is defined as any thromoemolism, bleeding, skin change, HIT, amputation, or other complication (as indicated by investigator). (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalMissing dataNo complicationsComplications
Fondaparinux120403149

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Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under UFH/LMWH Therapy

HIT II is characterized as a sudden decrease of thrombocyte count because of allergic response on heparin/platelet factor 4 (PF-4) complexes and is a severe and potentially fatal side effect of heparins. Usually, HIT occurs between Day 5 and Day 14 of exposure to UFH or LMWH. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo HIT II or missing dataHIT II
Fondaparinux1201119

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Number of Participants With Skin Changes Under Fondaparinux Therapy

No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo skin changes or missing data
Fondaparinux120120

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Number of Participants With Skin Changes Under UFH/LMWH Therapy

No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo skin changes or missing dataSkin changes
Fondaparinux1208040

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Number of Participants With the Indicated Outcome of Pregnancy by Type of Birth

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Missing dataSpontaneousInducedCaesarian sectionInduced/Caesarian section
Fondaparinux11713341

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Number of Participants With the Indicated Reason for Change to Fondaparinux

It was possible for a participant to have changed to fondaparinux for multiple reasons. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Heparin-induced thrombocytopenia (HIT)Allergy to heparinOther intolerancesLack of complianceFix doseNo monitoring of thrombocyte count necessaryMedical decision because of other reasonsOther reasons
Fondaparinux1250330164247

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Number of Participants With the Indicated Reason for the End of Fondaparinux Administration

It is possible that a participant stopped receiving Fondaparinux for multiple reasons. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
Missing dataEnd of thromboembolism prophylaxis/therapyChange to another antithrombotic agentThrombocytopenia (HIT II)Allergic reactionOther reasons
Fondaparinux18946005

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Number of Participants With the Indicated Type of Conception/Fertilization

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
MissingNormal conceptionInduced pregnancy with normal conceptionIn-vitro fertilization
Fondaparinux2107110

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Number of Participants With Thromboembolisms Under Fondaparinux Therapy

Any sign of thromboembolism as indicated by investigator was measured. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalEither missing data or no thromboembolisms
Fondaparinux120120

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Number of Participants With Thromboembolisms Under UFH/LMWH Therapy

Any sign of thromboembolism as indicated by investigator was measured. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo thromboembolism or missing dataThromboembolisms
Fondaparinux1201182

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Number of Participants With Heparin-induced Thrombocytopenia (HIT II) Under Fondaparinux Therapy

The participant with HIT II was pretreated with LMWH; however, the serious adverse event of HIT II was documented after the participant switched to Fondaparinux treatment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventionparticipants (Number)
TotalNo HIT II or missing dataHIT II
Fondaparinux1201191

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Duration From Start of Fondaparinux Therapy to HIT

For the 1 participant who developed HIT after receiving Fondaparinux, the number of days from start of therapy to HIT is presented. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Number)
Fondaparinux15

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Duration From Start of UFH/LMWH Therapy to HIT

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux27.5

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Duration From Start of UFH/LMWH Therapy to Skin Change

No formal definition for skin change was predetermined; documentation was based on the investigators' individual assessment. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux42

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Duration of All Hospitalizations Under UFH, LMWH, and Fondaparinux Administration

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux5

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Duration of Fondaparinux Administration

(NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux131

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Duration of Postnatal Fondaparinux Administration

The postnatal interval is defined as the interval of time beginning 2 days after birth. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux23

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Duration of Prenatal Fondaparinux Administration

The prenatal interval is defined as the interval of time until 3 days before birth. (NCT01004939)
Timeframe: 4 months (all cases occurred between 2004 and 2010)

Interventiondays (Median)
Fondaparinux130

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Number of Participants With the Indicated Types of Haemorrhages During Hospitalization or Follow-up for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first

,
Interventionparticipants (Number)
Bleeding or hematoma as complication of a surgeryEpistaxisGastrointestinal bleedsHemarthrosisIntracranial bleedsUrinary tract bleeding
Fondaparinux700001
Low Molecular Weight Heparins (LMWHs)1039211

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Number of Participants With the Indicated Haemorrhages During Hospitalization for Major Orthopaedic Surgery of Lower Limbs (MOSLL)

Haemorrhages during MOSLL hospitalization or follow-up as identified by ICD-9-CM codes were measured. The PHARMO medical record linkage system (RLS), in the Netherlands, is a population-based patient-centric data tracking system that includes high quality/ complete information of patient demographics, drug dispensing, and hospital morbidity records of approximately 2.3 million inhabitants in the Netherlands. (NCT01064362)
Timeframe: Follow-up continued until the date of first event, death, end of initial therapy, hospital discharge, end of follow-up in PHARMO RLS, or 60 days after discharge, whichever came first.

,
Interventionparticipants (Number)
Bleeding or hematoma as complication of a surgeryEpistaxis
Fondaparinux10
Low Molecular Weight Heparins (LMWHs)01

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Number of Participants Diagnosed With Bleeding After the Occurrence of HIT II

Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Bleeding was documented in the participant files. (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
No BleedingBleeding
Argatroban302
Argatroban/Danaparoid/Fondaparinux30
Argatroban/Fondaparinux110
Danaparoid433
Danaparoid/Argatroban83
Danaparoid/Fondaparinux50
Danaparoid/Fondaparinux/Lepirudin10
Danaparoid/Lepirudin22
Fondaparinux744
Lepirudin40

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Number of Participants With Fatal Complications After the Occurrence of HIT II

Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). A fatal complication is defined as a complication resulting in death. (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
No fatal complicationFatal complication
Argatroban275
Argatroban/Danaparoid/Fondaparinux30
Argatroban/Fondaparinux110
Danaparoid3511
Danaparoid/Argatroban92
Danaparoid/Fondaparinux50
Danaparoid/Fondaparinux/Lepirudin10
Danaparoid/Lepirudin22
Fondaparinux780
Lepirudin40

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Number of Participants Diagnosed With Thrombosis and/or Pulmonary Embolism After the Occurrence of HIT II

Thrombosis is a clotting in a blood vessel. Pulmonary embolism is a clot, usually from the deep veins of the legs, carried away with the venous bloodstream into the lungs, where it may block pulmonary vessels. Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
ThrombosisNo thrombosis or pulmonary embolismPulmonary embolismThrombosis and pulmonary embolismUnknown
Argatroban311000
Argatroban/Danaparoid/Fondaparinux30000
Argatroban/Fondaparinux110000
Danaparoid451000
Danaparoid/Argatroban64100
Danaparoid/Fondaparinux50000
Danaparoid/Fondaparinux/Lepirudin10000
Danaparoid/Lepirudin12100
Fondaparinux780000
Lepirudin40000

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Number of Participants Who Experienced Skin Changes (Erythema and Necrosis) After the Occurrence of HIT II

Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Erythema is a redness of the skin caused by hyperemia. Necrosis is the premature death of cells or tissues. (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
No skin changesSkin changes
Argatroban320
Argatroban/Danaparoid/Fondaparinux30
Argatroban/Fondaparinux110
Danaparoid451
Danaparoid/Argatroban110
Danaparoid/Fondaparinux50
Danaparoid/Fondaparinux/Lepirudin01
Danaparoid/Lepirudin31
Fondaparinux780
Lepirudin40

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Number of Participants Who Underwent Amputation After the Occurrence of HIT II

Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
No amputationAmputation
Argatroban320
Argatroban/Danaparoid/Fondaparinux30
Argatroban/Fondaparinux110
Danaparoid460
Danaparoid/Argatroban101
Danaparoid/Fondaparinux50
Danaparoid/Fondaparinux/Lepirudin10
Danaparoid/Lepirudin31
Fondaparinux780
Lepirudin40

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Number of Participants Who Were Diagnosed With Thrombocytopenia (Recurrent of Persistent) After the Occurrence of HIT II

Participants' medical records were used to abstract data that were collected on standardized hard copy Case Report Forms (CRFs). Thrombocytopenia after HIT-II was documented in the participant files. (NCT01304238)
Timeframe: 19 January 2005 to 25 October 2009

,,,,,,,,,
Interventionparticipants (Number)
Recurrent thrombocytopeniaPersistent thrombocytopeniaNo thrombocytopenia
Argatroban0131
Argatroban/Danaparoid/Fondaparinux021
Argatroban/Fondaparinux0011
Danaparoid1144
Danaparoid/Argatroban308
Danaparoid/Fondaparinux005
Danaparoid/Fondaparinux/Lepirudin001
Danaparoid/Lepirudin103
Fondaparinux0078
Lepirudin004

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To Determine Number of Participants Who Experienced a Bleeding Event, Either Major or Minor, and to Determine the Number of Participants Who Experienced a Venous Thromboembolism During the Study Period

Safety will be assessed through monitoring for clinical signs of bleeding. Major and minor bleeding will be documented. In additions, venous doppler studies of the bilateral lower extremities will be performed at study entry and study completion to monitor for any evidence of venous thromboembolism during the study period. We will report on the number of participants experiencing an adverse event during the study (NCT01467583)
Timeframe: 2 years

Interventionparticipants (Number)
Renal Failure on Intermittent Dialysis (IHD)0
Renal Failure-renal Replacement Therapy0
Renal Failure, Not on Dialysis0

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To Determine if an Adjusted-dose of Fondaparinux 2.5 mg Subcutaneously (SQ) q48 hr in Critically Ill Patients With Renal Failure Will Achieve Peak and Trough Levels Similar to Patients With Normal Renal Function on 2.5 mg SQ Daily Dosing of Fondaparinux.

Fondaparinux Peak Levels measured at time +3 hours after the dose, and Trough Levels, measured at time + 47 hours post-dose around the first 5 doses of fondaparinux and then every 3rd dose thereafter. Levels will be sent to our hospital laboratory and performed using a calibrated fondaparinux assay. (NCT01467583)
Timeframe: 2 years

,,
Interventionmcg/ml (Mean)
Peak LevelsTrough Levels
Renal Failure-continuous Renal Replacement Therapy0.310.12
Renal Failure, Not on Dialysis0.370.17
Renal Failure, on Intermittent Hemodialysis (IHD)0.420.18

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Rate of Major VTE

"composite of:~symptomatic pulmonary embolism~symptomatic proximal DVT~VTE-related death" (NCT01499953)
Timeframe: 90 +/-10 days

,
InterventionParticipants (Count of Participants)
Deep vein thrombosisPulmonary embolismVTE-related death
Fondaparinux200
Rivaroxaban600

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Clinically Relevant Non-major, Minor and Total (Any) Bleeding

"Clinically relevant, non-major bleeding is defined as any overt bleeding and~associated with a medical intervention, or~unscheduled contact with the physician (presence or telephone contact)~temporary or complete cessation of study drug~associated with any relevant discomfort to the patient (pain, impairment of activities of daily life)" (NCT01499953)
Timeframe: 45 +/- 5 days

,
InterventionParticipants (Count of Participants)
CRNM bleedingMinor bleedingAny bleeding
Fondaparinux11516
Rivaroxaban61520

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Rates of Surgery for SVT

(NCT01499953)
Timeframe: 90 +/-10 days

InterventionParticipants (Count of Participants)
Rivaroxaban0
Fondaparinux2

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Rate of Objectively Confirmed VTE Complications

The primary efficacy outcome was the composite of death from any cause, symptomatic pulmonary embolism (confirmed by ventilation-perfusion scanning, helical computed tomography, pulmonary angiography, or autopsy), symptomatic deep vein thrombosis (confirmed by ultrasonography or venography), or symptomatic extension towards the saphenofemoral junction or symptomatic recurrence of superficial vein thrombosis (confirmed by ultrasonography) up to day 45. (NCT01499953)
Timeframe: 45 +/- 5 days

InterventionParticipants (Count of Participants)
Rivaroxaban7
Fondaparinux4

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Major Bleeding (Main Safety Outcome)

"associated with a fall of hemoglobin of 2 g/l or more, or;~leading to a transfusion of 2 or more units of packed red blood cells or whole blood, or;~occurring into a critical site such as intracranial, intraspinal, intraocular, pericardial, intraarticular, intramuscular with compartment syndrome, retroperitoneal, or;~fatal bleeding." (NCT01499953)
Timeframe: 45 +/- 5 days

InterventionParticipants (Count of Participants)
Rivaroxaban0
Fondaparinux0

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Composite Primary Efficacy Outcome

For this, secondary efficacy outcomes were the composite primary efficacy outcome up to Day 90 and the following outcomes up to Day 45 and Day 90: each component of the primary efficacy outcome, the rate of major VTE (composite of symptomatic pulmonary embolism or symptomatic proximal DVT or VTE-related death) and the rates of surgery for SVT. (NCT01499953)
Timeframe: 90 +/- 10 days

InterventionParticipants (Count of Participants)
Rivaroxaban15
Fondaparinux15

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Blood Loss

requiring transfusion (NCT01809054)
Timeframe: 6 weeks

Interventionparticipants (Number)
Arixtra Arm6
Pneumatic Compression Stockings Arm1

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Deep Vein Thrombosis

verified by ultrasound (NCT01809054)
Timeframe: 6 weeks

Interventionparticipants (Number)
Arixtra Arm0
Pneumatic Compression Stockings Arm0

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Incidence of Any Adjudicated Bleeding Events

Incidence of any adjudicated bleeding events (including major bleeding, clinically relevant non-major bleeding, and minor bleeding). (NCT01857583)
Timeframe: 14 days

Interventionpercentage of subjects with bleeds (Number)
MiRI 30mg DU 176b (50 mL/Min ≤ CLCR ≤ 80 mL/Min)33.3
SRI 15mg DU 176b (15 mL/Min ≤ CLCR < 20 mL/Min)14.3
SRI 15mg DU 176b (20 mL/Min ≤ CLCR < 30 mL/Min)22.7
Fondaparinux (20 mL/Min ≤ CLCR < 30mL/Min)40.0

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Cumulative Rates of Major Bleeding

To compare the harms of DOAC vs. LMWH/warfarin therapy for cancer patients with VTE based on the cumulative rate of major bleeding at 6 months. d. Major bleeding was defined as Grade >=3 on the Common Terminology Criteria for Adverse Events from the National Cancer Institute (NCI CTCAE) criteria version 5.0 (i.e., severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care activities of daily living). (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)5.2
Randomized Arm 2 (LMWH)5.6
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)7.6

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Cumulative Non-Fatal VTE Recurrence at 6 Months (%)

To compare the effectiveness of anticoagulation with a DOAC (intervention) with LMWH/warfarin (comparator) for preventing VTE recurrence in patients with cancer based on cumulative VTE recurrence reported by patients or clinicians at 6 months. Only VTEs that were nonfatal were considered because of the challenges of attributing cause of death in cancer patients to tumor progression vs. VTE. (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)6.1
Randomized Arm 2 (LMWH)8.8
Preference Cohort 1 (DOACs)7.5
Preference Cohort 2 (LMWH)4.1

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 6 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.5
Randomized Arm 2 (LMWH)54.1
Preference Cohort 1 (DOACs)54.9
Preference Cohort 2 (LMWH)53.1

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 6 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 6-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.6
Randomized Arm 2 (LMWH)11.3
Preference Cohort 1 (DOACs)11.5
Preference Cohort 2 (LMWH)10.1

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Benefit of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the benefit of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The benefits scale has 3 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS benefits tool is then scored using the totals from each question with a total score from 3 to 15 possible. Higher scores signify greater satisfaction (greater benefits). (NCT02744092)
Timeframe: 3-months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)11.2
Randomized Arm 2 (LMWH)10.7
Preference Cohort 1 (DOACs)10.3
Preference Cohort 2 (LMWH)10.5

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Burden of Anticoagulation Therapy Reported by Participants Via the Anti-Clot Treatment Scale (ACTS) Questionnaire

To compare the burden of anticoagulation therapy with DOAC vs. with LMWH/warfarin for cancer patients with VTE at 3 months. The burden scale has12 items and patients are asked to rate their experiences on a 5-point scale of intensity (1=not at all, 2=a little, 3=moderately, 4=quite a bit, 5=extremely). The ACTS burden tool is then scored using the totals from each question with a total score from 12 to 60 possible. Higher scores signify greater satisfaction (lower burden). (NCT02744092)
Timeframe: 3 months

Interventionscore on a scale (Mean)
Randomized Arm 1 (DOACs)56.7
Randomized Arm 2 (LMWH)53.3
Preference Cohort 1 (DOACs)55.8
Preference Cohort 2 (LMWH)54.9

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Mortality Reported by Participants' Surrogates (Via Study-specific Questionnaire) or Clinicians (Via Study-specific Case Report Form)

To compare the impact of DOAC vs. LMWH/warfarin therapy on mortality in cancer patients with VTE based on survival at 6 months. Mortality was reported by participants' surrogates (via study-specific questionnaire) or clinicians (via study-specific case report form) (NCT02744092)
Timeframe: 6 months

Interventionpercentage of patients (Number)
Randomized Arm 1 (DOACs)21.5
Randomized Arm 2 (LMWH)18.4
Preference Cohort 1 (DOACs)16.3
Preference Cohort 2 (LMWH)23.8

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Number of Participants With No Change or Extension of Thrombotic Burden During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus at baseline and at Month 3. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: Randomization to Month 3

InterventionParticipants (Count of Participants)
Edoxaban21
Standard of Care29

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Number of Participants With No Change or Extension of Thrombotic Burden During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

No change or extension of thrombotic burden as assessed by quantitative diagnostic imaging of the index qualifying VTE thrombus. Imaging criteria for VTE included: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: From randomization up to Month 12

InterventionParticipants (Count of Participants)
Edoxaban35
Standard of Care47

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Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: From randomization up to Month 12

InterventionParticipants (Count of Participants)
Edoxaban7
Standard of Care2

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Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). (NCT02798471)
Timeframe: Randomization to Month 3

InterventionParticipants (Count of Participants)
Edoxaban3
Standard of Care5

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Number of Participants With Adjudicated Individual Component of Primary Efficacy Endpoints During the Main Treatment Period Following Edoxaban or Standard of Care Treatment

Diagnosis of recurrent VTE requires the confirmation imaging and ≥1 symptom of VTE. Death from VTE is based on diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. No change or extension of thrombotic burden (quantitative diagnostic imaging) of the index qualifying VTE thrombus. Imaging criteria for VTE: - Abnormal compression ultrasonography where compression had been normal or, if non-compressible during screening, an increase in diameter of the thrombus during full compression; - An extension of the echogenic intra-luminal thrombus or absence of flow in the central venous system on Doppler ultrasonography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect, or an extension of non-visualization of veins in the presence of a sudden cut-off on venography. - An extension of an intraluminal filling defect, or a new intraluminal filling defect on computed tomography angiogram (CTA). (NCT02798471)
Timeframe: Randomization to Month 3

,
InterventionParticipants (Count of Participants)
Symptomatic recurrent VTEPE with or without DVTDVT onlyDeath as a result of VTEUnexplained death which VTE cannot be ruled outNo change or extension of thrombotic burden
Edoxaban4041121
Standard of Care1101129

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Number of Participants With Symptomatic Recurrent Venous Thromboembolism During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: Randomization to Month 3

InterventionParticipants (Count of Participants)
Edoxaban5
Standard of Care2

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Number of Participants With All Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

All bleeding events included major bleeding defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells (RBCs), clinically relevant non-major bleeding defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug), nuisance bleeding, or a combination of bleeding events. (NCT02798471)
Timeframe: From randomization up to Month 12

InterventionParticipants (Count of Participants)
Edoxaban25
Standard of Care24

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Number of Participants Reporting Adjudicated All-Cause Mortality During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated)

All-cause mortality is defined as death due to any cause. Adjudicated data are reported for overall all-cause mortality, all-cause mortality by the primary cause of death, and primary cause of death further described by additional specifications. (NCT02798471)
Timeframe: From randomization up to Month 12

,
InterventionParticipants (Count of Participants)
Participants with adjudicated all-cause mortalityVenous thromboembolism (VTE)-related deathVenous thromboembolism (VTE)-related death: Unexplained death which VTE cannot be ruled outOther known causes of deathOther known causes of death: CancerOther known causes of death: Infectious diseaseOther known causes of death: Other
Edoxaban2111001
Standard of Care3112110

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Number of Participants Who Died as a Result of VTE During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: From randomization up to Month 12

,
InterventionParticipants (Count of Participants)
Pulmonary embolism (PE) with or without deep vein thrombosis (DVT)Fatal PENon-fatal PEDeep vein thrombosis (DVT) onlyFatal DVTNon-fatal DVTUnexplained death which VTE cannot be ruled out
Edoxaban1016051
Standard of Care1011001

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Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)

Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: Randomization to Month 3

,
InterventionParticipants (Count of Participants)
Death as a result of VTEUnexplained death which VTE cannot be ruled out
Edoxaban11
Standard of Care11

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Number of Participants Who Died as a Result of VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Death from venous thromboembolism (VTE) is based on objective diagnostic testing, autopsy or death which cannot be attributed to documented cause for which VTE cannot be ruled out. (NCT02798471)
Timeframe: Randomization to Month 3

,
InterventionParticipants (Count of Participants)
Pulmonary embolism (PE) with or without deep vein thrombosis (DVT)Fatal PENon-fatal PEDeep vein thrombosis (DVT) onlyFatal DVTNon-fatal DVTUnexplained death which VTE cannot be ruled out
Edoxaban0005041
Standard of Care1011001

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Number of Participants With Major and Clinically Relevant Non-Major Bleeding Events (On Treatment) During the Overall Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Composite)

Any bleeding event defined as major and clinically relevant non-major bleeding (CRNM) events was reported. Major bleeding was defined as defined as a composite of any of the following: fatal bleeding; and/or symptomatic bleeding in critical area or organ such as intracranial, intra-spinal, intraocular, retroperitoneal, intra-articular, pulmonary, or pericardial, or intramuscular with compartment syndrome; and/or bleeding that causes a decrease in hemoglobin of at least 2 g/dL or more, or leading to transfusion of the equivalent of two or more units of whole blood or red blood cells. CRNM was defined as acute or sub-acute clinically overt bleed that does not meet the criteria for a major bleed but prompts a clinical response, in that it leads to at least one of the following: a hospital admission for bleeding; a physician-guided medical or surgical treatment for bleeding or a change in antithrombotic therapy (including interruption or discontinuation of study drug). (NCT02798471)
Timeframe: From randomization up to Month 12

InterventionParticipants (Count of Participants)
Edoxaban8
Standard of Care5

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Number of Participants With Symptomatic Recurrent VTE During the Main Treatment Period Following Edoxaban or Standard of Care Treatment (Adjudicated Individual Component of Primary Efficacy Endpoint)

Diagnosis of recurrent venous thromboembolism (VTE) requires the confirmation by diagnostic imaging and at least one of the symptoms of VTE from such areas as lower or upper extremity, catheter related thrombosis, pulmonary embolism, or sinovenous thrombosis. (NCT02798471)
Timeframe: Randomization to Month 3

,
InterventionParticipants (Count of Participants)
Symptomatic VTEPulmonary embolism (PE) with or without deep vein thrombosis (DVT)Deep vein thrombosis (DVT) only
Edoxaban404
Standard of Care110

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